Page last updated: 2024-10-16

gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders

gamma-aminobutyric acid has been researched along with Sleep Initiation and Maintenance Disorders in 91 studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Sleep Initiation and Maintenance Disorders: Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.

Research Excerpts

ExcerptRelevanceReference
"Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design."9.19Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014)
"Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response."9.19Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014)
"To evaluate the efficacy and safety of pregabalin in the treatment of postherpetic neuralgia (PHN)."9.10Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003)
"The efficacy of a new drug, pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg), was studied on 100 patients affected by insomnia, associated with mood disorders."9.08Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders. ( Negri, L, 1997)
" Gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage-dependent calcium channels which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia."8.95Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
"We will include all randomised controlled trials (RCTs) reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia."8.95Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
"We studied the effects of low-dose ozone therapy on the sleep quality of patients with coronary heart disease (CHD) and insomnia by measuring the levels of brain-derived neurotrophic factor (BDNF) and GABA in blood serum."8.02Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA. ( Feng, X; Huang, H; Li, Y; Ren, H; Wang, Y; Yu, S, 2021)
"Forty chronic insomnia participants were randomized to either real or sham rTMS group."7.11Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study. ( Huang, X; Liang, K; Wang, C; Zhang, H, 2022)
" Given the maximal dosage studied, pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity."6.71Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003)
"Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy."6.55Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
"Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response."5.19Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014)
"Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design."5.19Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. ( Arnold, LM; Arsenault, P; Chew, ML; Clair, AG; Huffman, C; Messig, M; Patrick, JL; Pauer, L; Sanin, L; Scavone, JM, 2014)
"Pregabalin 150 to 600 mg/day was effective in relieving central neuropathic pain, improving sleep, anxiety, and overall patient status in patients with spinal cord injury."5.12Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. ( Chambers, R; Cousins, MJ; Griesing, T; Murphy, TK; Otte, A; Siddall, PJ, 2006)
"To evaluate the efficacy and safety of pregabalin in the treatment of postherpetic neuralgia (PHN)."5.10Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003)
"The efficacy of a new drug, pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg), was studied on 100 patients affected by insomnia, associated with mood disorders."5.08Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders. ( Negri, L, 1997)
"We will include all randomised controlled trials (RCTs) reported as double-blind and comparing gabapentin or pregabalin with placebo or any other active pharmacological treatment (any preparation, dose, frequency, route of delivery or setting) in patients with bipolar disorder, anxiety or insomnia."4.95Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
" Gabapentin and pregabalin, a very similar drug with the same mechanism of action, bind to a subunit of voltage-dependent calcium channels which are implicated in the aetiopathogenesis of bipolar disorder, anxiety and insomnia."4.95Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
"We studied the effects of low-dose ozone therapy on the sleep quality of patients with coronary heart disease (CHD) and insomnia by measuring the levels of brain-derived neurotrophic factor (BDNF) and GABA in blood serum."4.02Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA. ( Feng, X; Huang, H; Li, Y; Ren, H; Wang, Y; Yu, S, 2021)
"Considerable evidence implicates the neurotransmitter gamma-aminobutyric acid (GABA) in the biochemical pathophysiology of mood disorders."3.70GABAA alpha-1 subunit gene not associated with depressive symptomatology in mood disorders. ( Catalano, M; Cusin, C; Di Bella, D; Lattuada, E; Lilli, R; Macciardi, F; Serretti, A; Smeraldi, E, 1998)
"After 21-day sleep deprivation (SD) in platform water environment, CSD mice model was prepared."3.54Effects of BXSMD on ESR1 and ESR2 expression in CSD female mice. ( Liang, S; Liu, L; Liu, X; Wang, S; Yang, J; Zhang, Y, 2024)
"Forty chronic insomnia participants were randomized to either real or sham rTMS group."3.11Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study. ( Huang, X; Liang, K; Wang, C; Zhang, H, 2022)
"Both AB+AA and AA can relieve insomnia symptoms, but a stronger long-term effect were observed for AB+AA."3.11Effect of Auricular Acupoint Bloodletting plus Auricular Acupressure on Sleep Quality and Neuroendocrine Level in College Students with Primary Insomnia: A Randomized Controlled Trial. ( Chen, H; Huo, YX; Liu, DN; She, YF; Shi, XL; Sun, H; Wu, JA; Yuan, XR; Zhang, MJ, 2022)
"One hundred and thirty patients with insomnia were randomized into an observation group and a control group, 65 cases in each one."2.79[Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy]. ( Du, L; Liu, XC; Yang, JL; Yang, YS; Zhang, R, 2014)
"Individuals with major depressive disorder (MDD) often use hypnotics like zolpidem (Ambien(®)) to improve sleep in addition to their selective serotonin reuptake inhibitor (SSRI) regimen."2.79Zolpidem increases GABA in depressed volunteers maintained on SSRIs. ( Conn, NA; Jensen, JE; Licata, SC; Lukas, SE; Winer, JP, 2014)
"Aside from treating insomnia, using zolpidem in the presence of SSRIs may have some unidentified therapeutic effects for depressed individuals."2.79Zolpidem increases GABA in depressed volunteers maintained on SSRIs. ( Conn, NA; Jensen, JE; Licata, SC; Lukas, SE; Winer, JP, 2014)
"Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant."2.79A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. ( Furey, SA; Hull, SG; Jayawardena, S; Lankford, DA; Mayleben, DW; Rosenberg, RP; Roth, T; Seiden, DJ, 2014)
" The starting dosage of pregabalin was 75 mg/day and was increased up to as much as 300 mg/day, depending on the individual patient's condition, while tapering off hypnotics."2.79Effects of pregabalin in patients with hypnotic-dependent insomnia. ( Cho, YW; Song, ML, 2014)
"Gabapentin was associated with less %stage1 on Day 1, and greater %REM on Day 28, versus placebo."2.79A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. ( Furey, SA; Hull, SG; Jayawardena, S; Leibowitz, MT; Roth, T, 2014)
" Using plasma gabapentin concentration data obtained after administration of GEn in 12 phase 1 to 3 GEn studies in healthy adults or patients with RLS (dose range, 300-2400 mg/d), a population pharmacokinetic (PK) model was developed by nonlinear mixed-effect modeling using NONMEM."2.78Population pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbil. ( Cundy, KC; Lal, R; Lassauzet, ML; Luo, W; Sukbuntherng, J; Tovera, J, 2013)
"Insomnia is a common phenomenon particularly in patients with epilepsy."2.77Pregabalin increases slow-wave sleep and may improve attention in patients with partial epilepsy and insomnia. ( Bazil, CW; Cole, J; Dave, J; Drake, E; Stalvey, J, 2012)
"A 'high-insomnia' subgroup was defined by a baseline HAM for Depression (HAM-D) insomnia factor score greater than 3 (maximum = 6)."2.74The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia. ( Herman, BK; Mandel, FS; Montgomery, SA; Schweizer, E, 2009)
"To evaluate pregabalin in central neuropathic pain associated with spinal cord injury."2.72Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. ( Chambers, R; Cousins, MJ; Griesing, T; Murphy, TK; Otte, A; Siddall, PJ, 2006)
"Dizziness was the most common side effect."2.71Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. ( Bockbrader, H; Knapp, LE; Lamoreaux, L; Portenoy, R; Richter, RW; Sharma, U, 2005)
"Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo."2.71Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. ( Bockbrader, H; Knapp, LE; Lamoreaux, L; Portenoy, R; Richter, RW; Sharma, U, 2005)
" Given the maximal dosage studied, pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity."2.71Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. ( Bockbrader, H; Corbin, AE; Dworkin, RH; Garofalo, EA; LaMoreaux, L; Poole, RM; Sharma, U; Young, JP, 2003)
"Gabapentin is a calcium channel GABAergic modulator that is widely used for pain."2.58Gabapentin for the treatment of alcohol use disorder. ( Mason, BJ; Quello, S; Shadan, F, 2018)
"Expert opinion: Alcohol use disorder represents a challenge and large, unmet medical need."2.58Gabapentin for the treatment of alcohol use disorder. ( Mason, BJ; Quello, S; Shadan, F, 2018)
"Behavioral therapies for insomnia include the following: sleep hygiene, cognitive behavioral therapy for insomnia, multicomponent behavioral therapy or brief behavioral therapy for insomnia, relaxation strategies, stimulus control, and sleep restriction."2.55An update of management of insomnia in patients with chronic orofacial pain. ( Almoznino, G; Benoliel, R; Haviv, Y; Sharav, Y, 2017)
"Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy."2.55Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis. ( Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017)
"Chronic orofacial pain can greatly improve following treatment of the underlying insomnia, and therefore, re-evaluation of COFP is advised after 1 month of treatment."2.55An update of management of insomnia in patients with chronic orofacial pain. ( Almoznino, G; Benoliel, R; Haviv, Y; Sharav, Y, 2017)
"Sleep disorders are treated using anti-insomnia drugs that target ionotropic and G protein-coupled receptors (GPCRs), including γ-aminobutyric acid (GABA) agonists, melatonin agonists, and orexin receptor antagonists."2.53Sleep Control, GPCRs, and Glucose Metabolism. ( Sakurai, T; Sasaoka, T; Tsuneki, H, 2016)
"The consequences of insomnia, including issues with mood, behavior, and cognition, are discussed."2.53Pediatric Insomnia. ( Brown, KM; Malow, BA, 2016)
"Chronic insomnia is a common condition that affects people worldwide and has negative effects on patients' health and wellbeing."2.53Advances in the management of chronic insomnia. ( Attarian, H; Kay-Stacey, M, 2016)
"Therefore, insomnia and alcohol dependence might be best thought of as co-occurring disorders, each of which requires its own treatment."2.52Assessment and treatment of insomnia in adult patients with alcohol use disorders. ( Brower, KJ, 2015)
"Insomnia in patients with alcohol dependence has increasingly become a target of treatment due to its prevalence, persistence, and associations with relapse and suicidal thoughts, as well as randomized controlled studies demonstrating efficacy with behavior therapies and non-addictive medications."2.52Assessment and treatment of insomnia in adult patients with alcohol use disorders. ( Brower, KJ, 2015)
"Neuroimaging studies in primary insomnia remain relatively few, considering the important prevalence of this disorder in the general population."2.50Neuroimaging findings in primary insomnia. ( Berman Rosa, M; Dang-Vu, TT; Gouin, JP; O'Byrne, JN, 2014)
"This review aims to analyze pharmacokinetic profile, plasma level variations so as the metabolism, interactions and possible relation to clinical effect of several drugs which are used primarily as anxiolytics."2.49Understanding the pharmacokinetics of anxiolytic drugs. ( Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013)
"There is a need for a more balanced assessment of the benefits and risks associated with benzodiazepine use, particularly considering pharmacokinetic profile of the drugs to ensure that patients, who would truly benefit from these agents, are not denied appropriate treatment."2.49Understanding the pharmacokinetics of anxiolytic drugs. ( Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013)
"Suvorexant is a dual orexin antagonist currently in Phase III clinical trials for the modulation of sleep and is being developed by Merck."2.48ACS chemical neuroscience molecule spotlight on Suvorexant. ( Hopkins, CR, 2012)
"Therefore, exploring the anti-insomnia effects of volatile oils from HAD is of great importance."2.44Effects of aqueous extracts and volatile oils prepared from Huaxiang Anshen decoction on p-chlorophenylalanine-induced insomnia mice. ( Chen, D; He, C; Li, X; Pu, Y; Shen, M; Wang, M; Zhang, T; Zhou, J, 2024)
"It is hard to define what ratio of insomnia and daytime hypersomnia is caused by the antiparkinsonian treatment, by the somatic and mental-emotional symptoms of the neurodegenerative disease and by the neurodegenerative brain process itself."2.44[Sleep disorders in Parkinson syndromes]. ( Kovács, GG; Lalit, N; Péter, H; Szucs, A, 2007)
"Sleep-onset and maintenance insomnia is a characteristic feature of schizophrenic patients regardless of either their medication status (drug-naive or previously treated) or the phase of the clinical course (acute or chronic)."2.43Sleep disturbance in schizophrenia. ( Monti, D; Monti, JM, 2005)
"Chronic insomnia affects a significant proportion of young adult and elderly populations."2.43Treating insomnia: Current and investigational pharmacological approaches. ( Deacon, S; Ebert, B; Wafford, KA, 2006)
"Insomnia is a common symptom in schizophrenia, although it is seldom the predominant complaint."2.43Sleep disturbance in schizophrenia. ( Monti, D; Monti, JM, 2005)
"Some correlates of insomnia in alcoholic patients are identical to those observed in non-alcoholic insomniacs, including anxiety and depression, tobacco smoking, and the use of alcohol to aid sleep."2.42Insomnia, alcoholism and relapse. ( Brower, KJ, 2003)
" The safety and tolerability of GABA-BZ receptor agonists and SUX were high, and no serious adverse effects were observed after switching to LEM."1.91Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023)
"Insomnia is the most common sleep disorder and is often comorbid with mental and physical diseases."1.91Electroacupuncture of the cymba concha alleviates p-chlorophenylalanine-induced insomnia in mice. ( Peng, Q; Tang, L; Zhang, F; Zhang, X, 2023)
"AA have certain therapeutic effects on insomnia."1.91The Effect of Chinese Agarwood Essential Oil with Cyclodextrin Inclusion against PCPA-Induced Insomnia Rats. ( Chen, J; Hua, L; Lai, Y; Li, J; Shi, S; Xu, J; Yang, J; Zhang, S; Zhu, S, 2023)
"Although gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor agonists are used to treat insomnia, their long-term or high-dosage use causes adverse events."1.91Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023)
"The novel dual orexin receptor antagonist lemborexant (LEM) has fewer adverse effects than GABA-BZ receptor agonists."1.91Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant. ( Inamoto, A; Iwanami, A; Kawai, K; Okino, K; Sanada, K; Suzuki, H; Tomioka, H, 2023)
"That meets the main mechanism of insomnia in traditional Chinese medicine."1.72Jiaotaiwan increased GABA level in brain and serum, improved sleep via increasing NREM sleep and REM sleep, and its component identification. ( ChongLiang, L; LuFeng, H; Ren, Y; SiSi, L; Yuan, F; ZhengZhong, Y, 2022)
"In the caffeine-induced insomnia model, the administration of a Saaz-Saphir mixture increased the sleep time compared to Saaz or Saphir administration alone, which was attributed to the increase in NREM sleep time by the δ-wave increase."1.62GABA ( Ahn, Y; Cho, HJ; Jo, K; Kwak, WK; Min, B; Suh, HJ, 2021)
"In this study, PCPA-induced insomnia model was used to explore the sleep-promoting mechanism of enzymolysis peptides from PMM, and its main composition and chemical structure were analyzed."1.62Enzymolysis peptides from Mauremys mutica plastron improve the disorder of neurotransmitter system and facilitate sleep-promoting in the PCPA-induced insomnia mice. ( Luo, LS; Lv, YB; Yan, JX; Zhang, JL; Zhou, Q, 2021)
"Established the PCPA insomnia model of mice, The open field test, pentobarbital-induced falling asleep rate, latency of sleeping time, and duration of sleeping time experiments were used to evaluate the behavior of mice, the enzyme-linked immunosorbent assay was used to analyze the content of 5-HT and GABA in hypothalamus and cerebral cortex."1.62Sedative and hypnotic effects of Perilla frutescens essential oil through GABAergic system pathway. ( Du, Q; Guo, Y; Hu, P; Huang, X; Li, J; Li, W; Liu, S; Ren, G; Shuai, S; Wu, L; Xiao, S; Yang, M; Zhang, K; Zhang, M; Zheng, Q; Zhong, Y; Zhu, L, 2021)
"Insomnia is a common health problem in modern societies."1.56Beneficial effect of GABA-rich fermented milk on insomnia involving regulation of gut microbiota. ( Cen, S; Chen, W; Duan, H; Feng, S; Han, X; Tian, F; Xue, Y; Yu, L; Zhai, Q; Zhang, H; Zhao, J, 2020)
"The extent to which comorbid insomnia contributes to GABAergic or glutamatergic deficiencies in MDD remains unclear."1.56 ( Baer, L; Benson, KL; Bottary, R; Eric Jensen, J; Gonenc, A; Schoerning, L; Winkelman, JW, 2020)
"Both Major Depressive Disorder (MDD) and Primary Insomnia (PI) have been linked to deficiencies in cortical γ-aminobutyric acid (GABA) and glutamate (Glu) thus suggesting a shared neurobiological link between these two conditions."1.56 ( Baer, L; Benson, KL; Bottary, R; Eric Jensen, J; Gonenc, A; Schoerning, L; Winkelman, JW, 2020)
"Chronic insomnia is defined as a persistent difficulty with sleep initiation maintenance or non-restorative sleep."1.46The dual orexin receptor antagonist, DORA-22, lowers histamine levels in the lateral hypothalamus and prefrontal cortex without lowering hippocampal acetylcholine. ( Coleman, PJ; Fox, SV; Gotter, AL; Hodgson, R; Ramirez, AD; Renger, JJ; Roecker, AJ; Smith, SM; Uslaner, JM; Winrow, CJ; Yao, L, 2017)
"Chronic insomnia is one of the most prevalent central nervous system disorders."1.43Magnetic Resonance Spectroscopy in Patients with Insomnia: A Repeated Measurement Study. ( Baglioni, C; Feige, B; Hennig, J; Lange, T; Nissen, C; Regen, W; Riemann, D; Spiegelhalder, K, 2016)
"The findings have implications for PTSD treatment approaches."1.40Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014)
"As expected, PTSD+ had higher depressive and anxiety symptom scores and a higher Insomnia Severity Index (ISI) score."1.40Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014)
" Before dosing and at 30, 60, 120, 240 min, general behaviors within 5 min were recorded."1.40[Mechanism of Bailemian capsules in the treatment of insomnia in mice]. ( Bian, Y; Tang, X, 2014)
"In middle and high-dose groups, insomnia symptoms improved significantly."1.40[Mechanism of Bailemian capsules in the treatment of insomnia in mice]. ( Bian, Y; Tang, X, 2014)
"Insomnia is a prominent modern disease that affects an increasing population."1.40Discovery of novel insomnia leads from screening traditional Chinese medicine database. ( Chan, YC; Chang, SS; Chen, CY; Chen, HY, 2014)
"Twenty-seven patients with PTSD (PTSD+) and 18 trauma-exposed controls without PTSD (PTSD-), recruited from United States Army reservists, Army National Guard, and mental health clinics."1.40Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality. ( Metzler, T; Meyerhoff, DJ; Mon, A; Neylan, TC, 2014)
"Insomnia is prevalent in pediatrics, particularly in those with neurodevelopmental disorders."1.39Gabapentin shows promise in treating refractory insomnia in children. ( Malow, BA; Robinson, AA, 2013)
"The model of insomnia rats were established by PCPA intraperitoneal injection, after the modeling, all the therapeutic group were treated with corresponding drug for one week."1.39[Effects of extracts from ziziphi spinosae semen and schisandrae chinensis fructus on amino acid neurotransmitter in rats with insomnia induced by PCPA]. ( Chen, JF; Gao, JR; Ji, WB; Jiang, H, 2013)
"We report a case with refractory insomnia."1.39Treatment-resistant insomnia treated with pregabalin. ( Di Iorio, G; Di Tizio, L; Martinotti, G; Matarazzo, I, 2013)
"Gabapentin has shown promise in treating insomnia in adults."1.39Gabapentin shows promise in treating refractory insomnia in children. ( Malow, BA; Robinson, AA, 2013)
"Increased GABA levels in persons with insomnia may reflect an allostatic response to chronic hyperarousal."1.38Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012)
"Acupuncture can effectively suppress insomnia induced down-regulation of hypothalamic GABA and GABA(A)R in rats and lengthen pole-climbing time, which may contribute to its effect in relieving insomnia."1.38[Effect of acupuncture at different acupoints on expression of hypothalamic GABA and GABA(A) receptor proteins in insomnia rats]. ( Gao, XY; Ren, S; Wang, PY; Zhou, YL, 2012)
"Insomnia is closely related to major depressive disorder (MDD) both cross-sectionally and longitudinally, and as such, offers potential opportunities to refine our understanding of the neurobiology of both sleep and mood disorders."1.38Reduced γ-aminobutyric acid in occipital and anterior cingulate cortices in primary insomnia: a link to major depressive disorder? ( Jensen, JE; Plante, DT; Schoerning, L; Winkelman, JW, 2012)
"Non-medicated persons with primary insomnia (N = 16) and no sleep complaints (N = 17)."1.38Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012)
"The primary insomnia group was distinguished from persons with no sleep complaints on self-reported and polysomnographically measured sleep."1.38Cortical GABA levels in primary insomnia. ( Fasula, M; Forselius, E; Mason, GF; Morgan, PT; Pace-Schott, EF; Sanacora, G; Valentine, GW, 2012)
"Human transmissible spongiform encephalopathies (TSEs) or prion diseases are neurodegenerative disorders of infectious, inherited or sporadic origin and include Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker disease (GSS), kuru and fatal familial insomnia (FFI)."1.30Selective neuronal vulnerability in human prion diseases. Fatal familial insomnia differs from other types of prion diseases. ( Budka, H; Flicker, H; Guentchev, M; Voigtländer, T; Wanschitz, J, 1999)

Research

Studies (91)

TimeframeStudies, this research(%)All Research%
pre-19902 (2.20)18.7374
1990's6 (6.59)18.2507
2000's22 (24.18)29.6817
2010's39 (42.86)24.3611
2020's22 (24.18)2.80

Authors

AuthorsStudies
Hong, JSW1
Atkinson, LZ2
Al-Juffali, N1
Awad, A2
Geddes, JR2
Tunbridge, EM1
Harrison, PJ2
Cipriani, A2
SiSi, L1
Yuan, F1
LuFeng, H1
ChongLiang, L1
Ren, Y1
ZhengZhong, Y1
Min, B1
Ahn, Y2
Cho, HJ1
Kwak, WK1
Suh, HJ2
Jo, K1
Zhang, H2
Huang, X3
Wang, C2
Liang, K1
Zuo, CS1
Davis, KA1
Lukas, SE2
Kim, H1
Park, I1
Park, K1
Park, S1
Kim, YI1
Park, BG1
Wang, Y2
Gong, B1
Wu, Y1
Chen, X1
Liu, Y1
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Yuan, XR1
Huo, YX1
Sun, H1
Liu, DN1
Shi, XL1
Mu, K3
Zhang, J3
Feng, X4
Zhang, D3
Li, K3
Li, R3
Yang, P3
Mao, S3
Lai, Y1
Hua, L1
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Xu, J1
Chen, J1
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Okino, K1
Suzuki, H1
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Sanada, K1
Kawai, K1
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Ren, G2
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Zhai, Q1
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Benson, KL2
Bottary, R1
Schoerning, L2
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Gonenc, A1
Eric Jensen, J1
Winkelman, JW4
Wu, L1
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Li, W1
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Zhang, M1
Li, Y1
Ren, H1
Huang, H1
Yu, S1
Lv, YB1
Zhou, Q1
Yan, JX1
Luo, LS1
Zhang, JL1
Lee, S1
Jung, W1
Eom, S1
Yeom, HD1
Park, HD1
Lee, JH1
Houghton, KT1
Forrest, A1
Stockton, S1
Yao, L1
Ramirez, AD1
Roecker, AJ1
Fox, SV1
Uslaner, JM1
Smith, SM1
Hodgson, R1
Coleman, PJ1
Renger, JJ1
Winrow, CJ1
Gotter, AL1
Mason, BJ1
Quello, S1
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Feng, J1
Zhang, Q1
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Zhou, X1
Peplow, M1
Chen, HY1
Chang, SS1
Chan, YC1
Chen, CY2
Di Iorio, G1
Matarazzo, I1
Di Tizio, L1
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Krystal, AD1
Benca, RM1
Kilduff, TS1
Gao, JR1
Ji, WB1
Jiang, H1
Chen, JF1
Meyerhoff, DJ1
Mon, A1
Metzler, T1
Neylan, TC1
Cho, YW1
Song, ML1
Arnold, LM1
Arsenault, P1
Huffman, C1
Patrick, JL1
Messig, M1
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Sanin, L1
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Pauer, L1
Clair, AG1
Licata, SC1
Jensen, JE4
Conn, NA1
Winer, JP1
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Dang-Vu, TT1
Rosenberg, RP1
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Leibowitz, MT1
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Brower, KJ5
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Tsai, HY1
Myra Kim, H1
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Ellenbogen, AL1
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Barrett, RW1
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Sadosky, A1
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Mason, GF1
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Zhou, YL1
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Lassauzet, ML1
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Poole, RM1
Karam-Hage, M2
Staner, L1
Luthringer, R1
Macher, JP1
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Knapp, LE1
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Griesing, T1
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Voigtländer, T1
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Gessa, GL1

Clinical Trials (12)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)[NCT01271933]Phase 3441 participants (Actual)Interventional2011-03-31Completed
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance[NCT00674752]Phase 3377 participants (Actual)Interventional2006-03-31Completed
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.[NCT04818450]60 participants (Actual)Interventional2021-04-19Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance[NCT00163046]Phase 3256 participants (Actual)Interventional2005-10-31Completed
Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia[NCT05664295]60 participants (Actual)Observational [Patient Registry]2022-12-30Completed
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence[NCT03897062]Phase 222 participants (Actual)Interventional2019-08-26Terminated (stopped due to Recruitment problems during covid lockdowns resulted in Merck ceasing supply of suvorexant/placebo)
Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)[NCT04246619]Phase 4254 participants (Actual)Interventional2019-11-12Terminated (stopped due to The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.)
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study.[NCT00954187]8 participants (Actual)Interventional2009-11-30Terminated (stopped due to PI left institution)
Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia[NCT00595504]Phase 425 participants (Actual)Interventional2008-01-31Completed
Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia: a Randomized Clinical Trial[NCT01431092]Phase 486 participants (Actual)Interventional2011-10-31Completed
The Emergence of Abstract Structure Knowledge Across Learning and Sleep[NCT05746299]250 participants (Anticipated)Interventional2023-03-29Recruiting
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury[NCT04057456]Phase 3140 participants (Anticipated)Interventional2023-03-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6

Interventionhours (Mean)
Pregabalin (Single Blind Phase)0.7

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

InterventionMinutes (Least Squares Mean)
Pregabalin (Double Blind Phase)-3.5
Placebo (Double Blind Phase)-2.3

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

InterventionPercent of daytime (Least Squares Mean)
Pregabalin (Double Blind Phase)-1.4
Placebo (Double Blind Phase)-2.0

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

InterventionPercentage of immobile bouts (Least Squares Mean)
Pregabalin (Double Blind Phase)-2.5
Placebo (Double Blind Phase)-0.6

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

InterventionCounts of total daytime activity (Least Squares Mean)
Pregabalin (Double Blind Phase)-182.7
Placebo (Double Blind Phase)-6672.2

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

InterventionHours (Least Squares Mean)
Pregabalin (Double Blind Phase)0.5
Placebo (Double Blind Phase)0.1

Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit

The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

InterventionUnits on a scale (Least Squares Mean)
Pregabalin (Double Blind Phase)-2.6
Placebo (Double Blind Phase)-2.5

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

InterventionUnits on a scale (Least Squares Mean)
Pregabalin (Double Blind Phase)1.9
Placebo (Double Blind Phase)1.4

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

InterventionNumber of times the participant awakened (Least Squares Mean)
Pregabalin (Double Blind Phase)-0.5
Placebo (Double Blind Phase)-0.8

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

InterventionHours (Least Squares Mean)
Pregabalin (Double Blind Phase)0.6
Placebo (Double Blind Phase)0.4

Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

InterventionUnits on a scale (Least Squares Mean)
Pregabalin (Double Blind Phase)-2.9
Placebo (Double Blind Phase)-2.5

Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19

Interventionhours (Least Squares Mean)
Pregabalin (Double Blind Phase)0.7
Placebo (Double Blind Phase)0.5

Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)

Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 19

InterventionUnits on a scale (Least Squares Mean)
Pregabalin (Double Blind Phase)-3.1
Placebo (Double Blind Phase)-2.4

Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event

Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. (NCT01271933)
Timeframe: Randomization to Week 19

InterventionParticipants (Count of Participants)
Pregabalin (Double Blind Phase)34
Placebo (Double Blind Phase)41

Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)

The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). (NCT01271933)
Timeframe: Randomization to Week 19

InterventionDays (Median)
Pregabalin (Double Blind Phase)58
Placebo (Double Blind Phase)23

Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)

Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
Pregabalin (Single Blind Phase)-1.6

Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
Sleep disturbanceSnoringAwakening Short of Breath/with a HeadacheSleep adequacySomnolenceSleep Problems Index ISleep Problems Index II
Pregabalin (Single Blind Phase)-21.8-1.0-11.018.9-3.6-16.1-15.9

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

,
InterventionMinutes (Mean)
Minutes of Interrupted Sleep (Week 11)Minutes of Interrupted Sleep (Week 12)Minutes of Interrupted Sleep (Week 13)Minutes of Interrupted Sleep (Week 14)Minutes of Interrupted Sleep (Week 15)
Placebo (Double Blind Phase)2.5-1.70.4-1.8-0.5
Pregabalin (Double Blind Phase)-9.0-3.0-3.0-3.2-0.4

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

,
InterventionPercent of daytime (Mean)
Percent Sedentary (Week 11)Percent Sedentary (Week 12)Percent Sedentary (Week 13)Percent Sedentary (Week 14)Percent Sedentary (Week 15)
Placebo (Double Blind Phase)1.1-1.4-0.9-1.1-1.4
Pregabalin (Double Blind Phase)-0.7-0.8-1.3-2.1-1.5

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

,
InterventionPercentage of immobile bouts (Mean)
Sleep Fragmentation Index (Week 11)Sleep Fragmentation Index (Week 12)Sleep Fragmentation Index (Week 13)Sleep Fragmentation Index (Week 14)Sleep Fragmentation Index (Week 15)
Placebo (Double Blind Phase)0.1-0.4-0.3-0.6-0.9
Pregabalin (Double Blind Phase)-4.4-2.8-2.2-2.4-0.9

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

,
InterventionCounts of total daytime activity (Mean)
Total daytime activity (Week 11)Total daytime activity ((Week 12)Total daytime activity ((Week 13)Total daytime activity ((Week 14)Total daytime activity ((Week 15)
Placebo (Double Blind Phase)-2083.9-6691.1521.8-4523.8-4649.4
Pregabalin (Double Blind Phase)-1894.1-50.7-4362.4-179.7-4138.3

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

,
InterventionHours (Mean)
Total Sleep Time (Week 11)Total Sleep Time (Week 12)Total Sleep Time (Week 13)Total Sleep Time (Week 14)Total Sleep Time (Week 15)
Placebo (Double Blind Phase)0.00.10.10.10.3
Pregabalin (Double Blind Phase)0.50.50.40.40.2

Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionUnits on a scale (Mean)
Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20
Placebo (Double Blind Phase)-3.0-2.8-2.9-2.6-2.5-2.5-2.6-2.5-2.6-2.7-2.5-2.4-2.4-4.9
Pregabalin (Double Blind Phase)-3.4-3.3-3.2-3.2-3.1-3.4-3.2-3.2-3.4-3.1-3.4-3.2-3.1-2.7

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionUnits on a scale (Mean)
Sleep Quality (Week 7)Sleep Quality (Week 8)Sleep Quality (Week 9)Sleep Quality (Week 10)Sleep Quality (Week 11)Sleep Quality (Week 12)Sleep Quality (Week 13)Sleep Quality (Week 14) N=48,43Sleep Quality (Week 15)Sleep Quality (Week 16)Sleep Quality (Week 17)Sleep Quality (Week 18)Sleep Quality (Week 19)Sleep Quality (Week 20)
Placebo (Double Blind Phase)1.91.71.81.71.71.71.92.12.01.91.91.81.53.3
Pregabalin (Double Blind Phase)1.92.02.12.22.32.11.92.22.21.92.22.12.03.1

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionNumber of times the participant awakened (Mean)
Subjective No.of Awakenings after Sleep (Week 7)Subjective No.of Awakenings after Sleep (Week 8)Subjective No.of Awakenings after Sleep (Week 9)Subjective No.of Awakenings after Sleep (Week 10)Subjective No.of Awakenings after Sleep (Week 11)Subjective No.of Awakenings after Sleep (Week 12)Subjective No.of Awakenings after Sleep (Week 13)Subjective No.of Awakenings after Sleep (Week 14)Subjective No.of Awakenings after Sleep (Week 15)Subjective No.of Awakenings after Sleep (Week 16)Subjective No.of Awakenings after Sleep (Week 17)Subjective No.of Awakenings after Sleep (Week 18)Subjective No.of Awakenings after Sleep (Week 19)Subjective No.of Awakenings after Sleep (Week 20)
Placebo (Double Blind Phase)-1.0-0.8-1.1-0.9-0.9-0.8-1.0-1.1-1.1-1.0-0.9-1.0-0.9-1.5
Pregabalin (Double Blind Phase)-1.1-1.2-1.2-1.2-1.1-1.1-1.0-1.0-0.8-1.0-1.2-1.1-0.7-1.5

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionHours (Mean)
Subjective Total Sleep Time (Week 7)Subjective Total Sleep Time (Week 8)Subjective Total Sleep Time (Week 9)Subjective Total Sleep Time (Week 10)Subjective Total Sleep Time (Week 11)Subjective Total Sleep Time (Week 12)Subjective Total Sleep Time (Week 13)Subjective Total Sleep Time (Week 14)Subjective Total Sleep Time (Week 15)Subjective Total Sleep Time (Week 16)Subjective Total Sleep Time (Week 17)Subjective Total Sleep Time (Week 18)Subjective Total Sleep Time (Week 19)Subjective Total Sleep Time (Week 20)
Placebo (Double Blind Phase)0.50.60.50.50.60.50.60.70.70.70.70.50.60.5
Pregabalin (Double Blind Phase)0.70.90.80.90.90.80.70.90.70.70.70.60.5-0.1

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

,
InterventionMinutes (Least Squares Mean)
Subjective Wake after Sleep OnsetSubjective Latency to Sleep Onset
Placebo (Double Blind Phase)-20.6-11.9
Pregabalin (Double Blind Phase)-26.2-10.6

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionMinutes (Mean)
Subjective Wake after Sleep Onset (Week 7)Subjective Wake after Sleep Onset (Week 8)Subjective Wake after Sleep Onset (Week 9)Subjective Wake after Sleep Onset (Week 10)Subjective Wake after Sleep Onset (Week 11)Subjective Wake after Sleep Onset (Week 12)Subjective Wake after Sleep Onset (Week 13)Subjective Wake after Sleep Onset (Week 14)Subjective Wake after Sleep Onset (Week 15)Subjective Wake after Sleep Onset (Week 16)Subjective Wake after Sleep Onset (Week 17)Subjective Wake after Sleep Onset (Week 18)Subjective Wake after Sleep Onset (Week 19)Subjective Wake after Sleep Onset (Week 20)Subjective Latency to Sleep Onset (Week 7)Subjective Latency to Sleep Onset (Week 8)Subjective Latency to Sleep Onset (Week 9)Subjective Latency to Sleep Onset (Week 10)Latency to Sleep Onset (Week 11)Subjective Latency to Sleep Onset (Week 12)Subjective Latency to Sleep Onset (Week 13)Subjective Latency to Sleep Onset (Week 14)Subjective Latency to Sleep Onset (Week 15)Subjective Latency to Sleep Onset (Week 16)Subjective Latency to Sleep Onset (Week 17)Subjective Latency to Sleep Onset (Week 18)Subjective Latency to Sleep Onset (Week 19)Subjective Latency to Sleep Onset (Week 20)
Placebo (Double Blind Phase)-32.0-28.0-33.2-26.2-37.4-31.0-31.4-43.3-35.1-35.0-36.2-37.3-23.1-7.1-19.1-12.3-16.0-18.0-18.0-18.8-16.8-21.8-19.1-20.9-20.9-18.7-19.5-28.7
Pregabalin (Double Blind Phase)-27.8-27.4-27.0-26.9-29.0-26.0-22.8-27.0-31.7-25.9-31.5-32.4-27.3-22.5-15.6-19.1-18.4-19.5-18.5-16.3-17.5-20.8-19.4-15.8-23.1-16.3-16.723.0

Double-Blind Phase: Change From Baseline in FIQ Score at Week 19

The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
Item 1: Physical activitiesItem 2: feel goodItem 3: Work missedItem 4: Do jobItem 5: PainItem 6: FatigueItem 7: RestedItem 8: StiffnessItem 9: AnxietyItem 10: DepressionTotal Score
Placebo (Double Blind Phase)-1.3-3.2-1.0-2.2-2.2-2.4-2.2-2.2-1.7-0.7-19.1
Pregabalin (Double Blind Phase)-1.0-3.0-1.2-2.1-2.7-2.3-2.6-2.4-1.8-0.7-19.6

Double-Blind Phase: Change From Baseline in HADS Score at Week 19

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
HADS-A Anxiety scaleHADS-D Depression scale
Placebo (Double Blind Phase)-1.6-1.1
Pregabalin (Double Blind Phase)-0.7-1.4

Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

,
InterventionUnits on a scale (Mean)
Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20
Placebo (Double Blind Phase)-3.0-2.7-2.8-2.4-2.6-2.6-2.6-2.5-2.6-2.6-2.5-2.5-2.4-4.9
Pregabalin (Double Blind Phase)-3.9-3.7-3.6-3.7-3.7-3.7-3.6-3.5-3.6-3.4-3.6-3.4-3.4-3.0

Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
Sleep disturbanceSnoringAwakening Short of Breath/with a HeadacheSleep adequacySomnolenceSleep Problems Index ISleep Problems Index II
Placebo (Double Blind Phase)-15.5-2.9-4.217.1-6.6-13.7-14.0
Pregabalin (Double Blind Phase)-25.4-2.4-8.123.9-11.9-19.5-19.7

Double-Blind Phase: Change From Baseline in MFI Score at Week 19

The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
General fatiguePhysical fatigueReduced activityReduced motivationMental fatigue
Placebo (Double Blind Phase)-0.10.2-0.30.30.1
Pregabalin (Double Blind Phase)0.1-0.10.01.0-0.1

Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
SF-36 Physical FunctioningSF-36 Role-PhysicalSF-36 Pain IndexSF-36 General Health PerceptionsSF-36 VitalitySF-36 Social FunctioningSF-36 Role-EmotionalSF-36 Mental Health IndexPhysical Component ScoreMental Component Score
Placebo (Double Blind Phase)13.716.216.09.315.713.52.25.27.22.4
Pregabalin (Double Blind Phase)12.418.919.23.312.213.33.86.66.82.6

Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19

WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 19

,
InterventionUnits on a scale (Least Squares Mean)
Percent Work Time MissedPercent Impairment While WorkingPercent Activity ImpairmentPercent Overall Work Impairment
Placebo (Double Blind Phase)-26.7-15.0-19.6-17.5
Pregabalin (Double Blind Phase)-7.3-14.0-16.4-15.9

Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 19

,
InterventionParticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Placebo (Double Blind Phase)7111211682
Pregabalin (Double Blind Phase)715149771

Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19

The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 19

,
InterventionParticipants (Number)
Benefit from treatment-NoBenefit from treatment-Little benefitBenefit from treatment-much benefitSatisfaction from treatment-very dissatisfiedSatisfaction from treatment-a little dissatisfiedSatisfaction from treatment-a little satisfiedSatisfaction from treatment-very satisfiedWilling to continue treatment-very unwillingWilling to continue treatment-little unwillingWilling to continue treatment-little bit willingWilling to continue treatment-very willing
Placebo (Double Blind Phase)111630681330481134
Pregabalin (Double Blind Phase)31541410103686937

Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)

C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20

,
InterventionParticipants (Number)
Week 11Week 15Week 19Week 20
Placebo (Double Blind Phase)0131
Pregabalin (Double Blind Phase)3111

Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)

C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20

InterventionParticipants (Number)
Week 1Week 2Week 3Week 6Week 7
Pregabalin (Single Blind Phase)5641610

Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

InterventionPercentage of immobile bouts (Mean)
Sleep Fragmentation Index (Week 3)Sleep Fragmentation Index (Week 4)Sleep Fragmentation Index (Week 5)Sleep Fragmentation Index (Week 6)Sleep Fragmentation Index (Week 7)
Pregabalin (Single Blind Phase)-0.8-2.5-2.8-2.60.7

Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
SF-36 Physical FunctioningSF-36 Role-PhysicalSF-36 Pain IndexSF-36 General Health PerceptionsSF-36 VitalitySF-36 Social FunctioningSF-36 Role-EmotionalSF-36 Mental Health IndexPhysical Component ScoreMental Component Score
Pregabalin (Single Blind Phase)14.017.820.78.518.212.98.67.97.24.5

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

InterventionMinutes (Mean)
Minutes of Interrupted Sleep (Week 3)Minutes of Interrupted Sleep (Week 4)Minutes of Interrupted Sleep (Week 5)Minutes of Interrupted Sleep (Week 6)Minutes of Interrupted Sleep (Week 7)
Pregabalin (Single Blind Phase)-5.3-5.9-7.0-6.60.7

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

InterventionPercent of daytime (Mean)
Percent Sedentary (Week 3)Percent Sedentary (Week 4)Percent Sedentary (Week 5)Percent Sedentary (Week 6)Percent Sedentary (Week 7)
Pregabalin (Single Blind Phase)0.70.70.60.30.2

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

InterventionCounts of total daytime activity (Mean)
Total daytime activity (Week 3)Total daytime activity (Week 4)Total daytime activity (Week 5)Total daytime activity (Week 6)Total daytime activity (Week 7)
Pregabalin (Single Blind Phase)10264.310588.18635.87134.218420.7

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

InterventionHours (Mean)
Total Sleep Time (Week 3)Total Sleep Time (Week 4)Total Sleep Time (Week 5)Total Sleep Time (Week 6)Total Sleep Time (Week 7)
Pregabalin (Single Blind Phase)-0.10.40.30.30.6

Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6

The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionUnits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6
Pregabalin (Single Blind Phase)-0.7-1.2-1.6-2.0-2.2-2.3

Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionNumber of times the participant awakened (Mean)
Subjective No.of Awakenings after Sleep (Week 1)Subjective No.of Awakenings after Sleep (Week 2)Subjective No.of Awakenings after Sleep (Week 3)Subjective No.of Awakenings after Sleep (Week 4)Subjective No.of Awakenings after Sleep (Week 5)Subjective No.of Awakenings after Sleep (Week 6)
Pregabalin (Single Blind Phase)-0.8-1.0-1.1-1.1-1.2-1.2

Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionHours (Mean)
Subjective Total Sleep Time (Week 1)Subjective Total Sleep Time (Week 2)Subjective Total Sleep Time (Week 3)Subjective Total Sleep Time (Week 4)Subjective Total Sleep Time (Week 5)Subjective Total Sleep Time (Week 6)
Pregabalin (Single Blind Phase)0.60.60.60.70.70.7

Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionUnits on a scale (Mean)
Sleep quality (Week 1)Sleep quality (Week 2)Sleep quality (Week 3)Sleep quality (Week 4)Sleep quality (Week 5)Sleep quality (Week 6)
Pregabalin (Single Blind Phase)1.01.21.51.61.71.7

Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionMinutes (Mean)
Subjective Wake after Sleep Onset (Week 1)Subjective Wake after Sleep Onset (Week 2)Subjective Wake after Sleep Onset (Week 3)Subjective Wake after Sleep Onset (Week 4)Subjective Wake after Sleep Onset (Week 5)Subjective Wake after Sleep Onset (Week 6)Subjective Latency to Sleep Onset (Week 1)Subjective Latency to Sleep Onset (Week 2)Subjective Latency to Sleep Onset (Week 3)Subjective Latency to Sleep Onset (Week 4)Subjective Latency to Sleep Onset (Week 5)Subjective Latency to Sleep Onset (Week 6)
Pregabalin (Single Blind Phase)-19.1-22.4-25.0-27.5-31.4-32.8-10.3-13.0-15.5-19.6-20.0-16.9

Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6

The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
Item 1: Physical activitiesItem 2: Feel goodItem 3: Work missedItem 4: Do jobItem 5: PainItem 6: FatigueItem 7: RestedItem 8: StiffnessItem 9: AnxietyItem 10: DepressionTotal Score
Pregabalin (Single Blind Phase)-0.9-2.2-0.5-1.5-1.6-1.4-1.7-1.8-1.2-0.6-13.4

Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
HADS-A Anxiety scaleHADS-D Depression scale
Pregabalin (Single Blind Phase)-1.8-1.5

Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

InterventionUnits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6
Pregabalin (Single Blind Phase)-0.9-1.5-2.0-2.3-2.5-2.6

Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6

The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
General fatiguePhysical fatigueReduced activityReduced motivationMental fatigue
Pregabalin (Single Blind Phase)-0.20.1-0.20.2-0.1

Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6

WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 6

InterventionUnits on a scale (Mean)
Percent Work Time MissedPercent Impairment While WorkingPercent Activity ImpairmentPercent Overall Work Impairment
Pregabalin (Single Blind Phase)-5.8-10.0-13.5-12.3

Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 6

InterventionParticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Pregabalin (Single Blind Phase)24771034616185

Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6

The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 6

InterventionParticipants (Number)
Benefit from treatment-NoBenefit from treatment-Little benefitBenefit from treatment-much benefitSatisfaction from treatment-very dissatisfiedSatisfaction from treatment-a little dissatisfiedSatisfaction from treatment-a little satisfiedSatisfaction from treatment-very satisfiedWilling to continue treatment-very unwillingWilling to continue treatment-little unwillingWilling to continue treatment-little bit willingWilling to continue treatment-very willing
Pregabalin (Single Blind Phase)691372115259103203683349266

Change in Abdominal Fat (DEXA).

A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8

Interventiong (Mean)
Ramelteon3934.86
Placebo (Sugar Pill)5120.92

Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).

A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8

InterventionHOMA score (Mean)
Ramelteon2.4
Placebo (Sugar Pill)2.36

Change in Waist Circumference

A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8

Interventioncm (Mean)
Ramelteon106.09
Placebo (Sugar Pill)108.37

Reviews

23 reviews available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders

ArticleYear
Gabapentin and pregabalin in bipolar disorder, anxiety states, and insomnia: Systematic review, meta-analysis, and rationale.
    Molecular psychiatry, 2022, Volume: 27, Issue:3

    Topics: Amines; Anxiety; Bipolar Disorder; Calcium Channels; Cyclohexanecarboxylic Acids; Gabapentin; gamma-

2022
Effects of BXSMD on ESR1 and ESR2 expression in CSD female mice.
    Journal of ethnopharmacology, 2024, Jan-10, Volume: 318, Issue:Pt B

    Topics: Animals; Estrogen Receptor alpha; Estrogen Receptor beta; Female; gamma-Aminobutyric Acid; Mice; RNA

2024
Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis.
    BMJ open, 2017, 03-27, Volume: 7, Issue:3

    Topics: Amines; Anti-Anxiety Agents; Anxiety Disorders; Bipolar Disorder; Cyclohexanecarboxylic Acids; Doubl

2017
Gabapentin for the treatment of alcohol use disorder.
    Expert opinion on investigational drugs, 2018, Volume: 27, Issue:1

    Topics: Alcohol Drinking; Alcoholism; Amines; Animals; Calcium Channel Blockers; Cyclohexanecarboxylic Acids

2018
Understanding the sleep-wake cycle: sleep, insomnia, and the orexin system.
    The Journal of clinical psychiatry, 2013, Volume: 74 Suppl 1

    Topics: Animals; Benzodiazepines; Brain; Brain Mapping; Circadian Rhythm; Cognitive Behavioral Therapy; Comb

2013
Neuroimaging findings in primary insomnia.
    Pathologie-biologie, 2014, Volume: 62, Issue:5

    Topics: Affective Symptoms; Arousal; Cerebral Cortex; Comorbidity; gamma-Aminobutyric Acid; Hippocampus; Hum

2014
Assessment and treatment of insomnia in adult patients with alcohol use disorders.
    Alcohol (Fayetteville, N.Y.), 2015, Volume: 49, Issue:4

    Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Amines; Anti-Anxiety Agents; Anticonvulsants; Antipsych

2015
Pediatric Insomnia.
    Chest, 2016, Volume: 149, Issue:5

    Topics: Actigraphy; Adolescent; Amines; Anti-Anxiety Agents; Autism Spectrum Disorder; Central Nervous Syste

2016
Not a single but multiple populations of GABAergic neurons control sleep.
    Sleep medicine reviews, 2017, Volume: 32

    Topics: Animals; Brain; GABAergic Neurons; gamma-Aminobutyric Acid; Humans; Rats; Receptors, GABA; Sleep; Sl

2017
Advances in the management of chronic insomnia.
    BMJ (Clinical research ed.), 2016, 07-06, Volume: 354

    Topics: Cognitive Behavioral Therapy; GABA Agents; gamma-Aminobutyric Acid; Humans; Prevalence; Relaxation T

2016
Sleep Control, GPCRs, and Glucose Metabolism.
    Trends in endocrinology and metabolism: TEM, 2016, Volume: 27, Issue:9

    Topics: Animals; gamma-Aminobutyric Acid; Glucose; Humans; Melatonin; Receptors, G-Protein-Coupled; Sleep; S

2016
An update of management of insomnia in patients with chronic orofacial pain.
    Oral diseases, 2017, Volume: 23, Issue:8

    Topics: Amines; Anticonvulsants; Antidepressive Agents; Benzodiazepines; Chronic Pain; Cognitive Behavioral

2017
[Update on the treatment of restless legs syndrome].
    Brain and nerve = Shinkei kenkyu no shinpo, 2009, Volume: 61, Issue:5

    Topics: Amines; Analgesics, Opioid; Anticonvulsants; Baths; Benzodiazepines; Cyclohexanecarboxylic Acids; Do

2009
ACS chemical neuroscience molecule spotlight on Suvorexant.
    ACS chemical neuroscience, 2012, Sep-19, Volume: 3, Issue:9

    Topics: Animals; Azepines; Clinical Trials, Phase I as Topic; Clinical Trials, Phase III as Topic; gamma-Ami

2012
Understanding the pharmacokinetics of anxiolytic drugs.
    Expert opinion on drug metabolism & toxicology, 2013, Volume: 9, Issue:4

    Topics: Adrenergic beta-Antagonists; Amines; Anti-Anxiety Agents; Anticonvulsants; Anxiety Disorders; Atenol

2013
[Development of compounds active in insomnia: recent developments and methodological aspects].
    Revue neurologique, 2003, Volume: 159, Issue:11 Suppl

    Topics: Benzodiazepines; Circadian Rhythm; Clinical Trials as Topic; Drug Design; GABA Agonists; GABA-A Rece

2003
Insomnia, alcoholism and relapse.
    Sleep medicine reviews, 2003, Volume: 7, Issue:6

    Topics: Acetylcholine; Adenosine; Alcoholism; Dopamine; gamma-Aminobutyric Acid; Glutamic Acid; Humans; Nore

2003
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Sleep disturbance in schizophrenia.
    International review of psychiatry (Abingdon, England), 2005, Volume: 17, Issue:4

    Topics: Brain; Dopamine; gamma-Aminobutyric Acid; Humans; Schizophrenia; Sleep Initiation and Maintenance Di

2005
Treating insomnia: Current and investigational pharmacological approaches.
    Pharmacology & therapeutics, 2006, Volume: 112, Issue:3

    Topics: Animals; Electroencephalography; GABA-A Receptor Agonists; gamma-Aminobutyric Acid; Humans; Hypnotic

2006
[Sleep disorders in Parkinson syndromes].
    Ideggyogyaszati szemle, 2007, May-30, Volume: 60, Issue:5-6

    Topics: Acetylcholine; Antidepressive Agents; Antiparkinson Agents; Diagnosis, Differential; Disorders of Ex

2007
Pontine reticular formation (PnO) administration of hypocretin-1 increases PnO GABA levels and wakefulness.
    Sleep, 2008, Volume: 31, Issue:4

    Topics: Animals; Arousal; Body Temperature; gamma-Aminobutyric Acid; Injections; Intracellular Signaling Pep

2008
Sleep-promoting effects of melatonin: at what dose, in whom, under what conditions, and by what mechanisms?
    Sleep, 1997, Volume: 20, Issue:10

    Topics: Adult; Aged; Body Temperature Regulation; Circadian Rhythm; gamma-Aminobutyric Acid; Humans; Hypnoti

1997
Sex, steroids, and sleep: a review.
    Sleep, 1999, Aug-01, Volume: 22, Issue:5

    Topics: Animals; Depressive Disorder; Female; gamma-Aminobutyric Acid; Gonadal Steroid Hormones; Humans; Hyp

1999

Trials

23 trials available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders

ArticleYear
Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study.
    Sleep medicine, 2022, Volume: 92

    Topics: Dorsolateral Prefrontal Cortex; gamma-Aminobutyric Acid; Humans; Magnetic Resonance Spectroscopy; Pr

2022
Effect of Auricular Acupoint Bloodletting plus Auricular Acupressure on Sleep Quality and Neuroendocrine Level in College Students with Primary Insomnia: A Randomized Controlled Trial.
    Chinese journal of integrative medicine, 2022, Volume: 28, Issue:12

    Topics: Acupressure; Acupuncture Points; Bloodletting; gamma-Aminobutyric Acid; Humans; Sleep Initiation and

2022
[Effect of acupuncture combined with low frequency rTMS on comorbid mild-to-moderate depressive disorder and insomnia: a randomized controlled trial].
    Zhongguo zhen jiu = Chinese acupuncture & moxibustion, 2023, Apr-12, Volume: 43, Issue:4

    Topics: Acupuncture Points; Acupuncture Therapy; Brain-Derived Neurotrophic Factor; Depressive Disorder; gam

2023
Effects of pregabalin in patients with hypnotic-dependent insomnia.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, May-15, Volume: 10, Issue:5

    Topics: Female; gamma-Aminobutyric Acid; Humans; Hypnotics and Sedatives; Male; Middle Aged; Pregabalin; Sle

2014
Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
    Current medical research and opinion, 2014, Volume: 30, Issue:10

    Topics: Adult; Aged; Analgesics; Delayed-Action Preparations; Double-Blind Method; Drug Dosage Calculations;

2014
Zolpidem increases GABA in depressed volunteers maintained on SSRIs.
    Psychiatry research, 2014, Oct-30, Volume: 224, Issue:1

    Topics: Adult; Depressive Disorder, Major; Female; GABA-A Receptor Agonists; gamma-Aminobutyric Acid; Humans

2014
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, 10-15, Volume: 10, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic

2014
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, 10-15, Volume: 10, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic

2014
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, 10-15, Volume: 10, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic

2014
A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, 10-15, Volume: 10, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic

2014
A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014, 10-15, Volume: 10, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Calcium Channel Blockers; Cyclohexanecarboxylic

2014
[Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy].
    Zhongguo zhen jiu = Chinese acupuncture & moxibustion, 2014, Volume: 34, Issue:12

    Topics: Acupuncture Points; Acupuncture Therapy; Acupuncture, Ear; Adult; Aged; Female; gamma-Aminobutyric A

2014
A randomized double-blind pilot trial of gabapentin versus placebo to treat alcohol dependence and comorbid insomnia.
    Alcoholism, clinical and experimental research, 2008, Volume: 32, Issue:8

    Topics: Adult; Alcohol Drinking; Alcoholism; Amines; Antimanic Agents; Cyclohexanecarboxylic Acids; Dose-Res

2008
Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.
    Neurology, 2009, Feb-03, Volume: 72, Issue:5

    Topics: Adult; Amines; Anti-Anxiety Agents; Carbamates; Central Nervous System; Cyclohexanecarboxylic Acids;

2009
The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome.
    Sleep medicine, 2009, Volume: 10, Issue:6

    Topics: Analgesics; Double-Blind Method; Female; Fibromyalgia; gamma-Aminobutyric Acid; Humans; Male; Medica

2009
Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia.
    Health and quality of life outcomes, 2009, Jun-17, Volume: 7

    Topics: Adult; Analysis of Variance; Double-Blind Method; Female; Fibromyalgia; gamma-Aminobutyric Acid; Hum

2009
The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia.
    International clinical psychopharmacology, 2009, Volume: 24, Issue:4

    Topics: Adult; Anxiety Disorders; Benzodiazepines; Double-Blind Method; Female; gamma-Aminobutyric Acid; Hum

2009
Pregabalin increases slow-wave sleep and may improve attention in patients with partial epilepsy and insomnia.
    Epilepsy & behavior : E&B, 2012, Volume: 23, Issue:4

    Topics: Adolescent; Adult; Anticonvulsants; Attention Deficit Disorder with Hyperactivity; Cross-Over Studie

2012
Population pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbil.
    Journal of clinical pharmacology, 2013, Volume: 53, Issue:1

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amines; Carbamates; Cyclohexanecarboxylic Acids; Female;

2013
Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial.
    Neurology, 2003, Apr-22, Volume: 60, Issue:8

    Topics: Adult; Affect; Aged; Analgesics, Non-Narcotic; Dizziness; Double-Blind Method; Edema; Female; gamma-

2003
Open pilot study of gabapentin versus trazodone to treat insomnia in alcoholic outpatients.
    Psychiatry and clinical neurosciences, 2003, Volume: 57, Issue:5

    Topics: Acetates; Alcoholism; Amines; Antidepressive Agents, Second-Generation; Cyclohexanecarboxylic Acids;

2003
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
    The journal of pain, 2005, Volume: 6, Issue:4

    Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N

2005
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
    The journal of pain, 2005, Volume: 6, Issue:4

    Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N

2005
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
    The journal of pain, 2005, Volume: 6, Issue:4

    Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N

2005
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
    The journal of pain, 2005, Volume: 6, Issue:4

    Topics: Aged; Analgesia; Analgesics; Anticonvulsants; Calcium Channel Blockers; Calcium Channels; Diabetic N

2005
Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial.
    Neurology, 2006, Nov-28, Volume: 67, Issue:10

    Topics: Adult; Affect; Aged; Aged, 80 and over; Analgesics; Anxiety; Disability Evaluation; Dose-Response Re

2006
Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2007, Aug-15, Volume: 3, Issue:5

    Topics: Adult; Aged; Anticonvulsants; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administra

2007
Evaluation of the efficacy of pivagabine on insomnia associated with mood disorders.
    Arzneimittel-Forschung, 1997, Volume: 47, Issue:11A

    Topics: Adult; Blood Pressure; Double-Blind Method; Female; gamma-Aminobutyric Acid; Heart Rate; Humans; Mal

1997
Gabapentin treatment for insomnia associated with alcohol dependence.
    The American journal of psychiatry, 2000, Volume: 157, Issue:1

    Topics: Acetates; Adult; Alcoholism; Amines; Anticonvulsants; Comorbidity; Cyclohexanecarboxylic Acids; Fema

2000

Other Studies

45 other studies available for gamma-aminobutyric acid and Sleep Initiation and Maintenance Disorders

ArticleYear
Jiaotaiwan increased GABA level in brain and serum, improved sleep via increasing NREM sleep and REM sleep, and its component identification.
    Journal of ethnopharmacology, 2022, Mar-01, Volume: 285

    Topics: Animals; Brain; Drugs, Chinese Herbal; gamma-Aminobutyric Acid; Male; Mice; Rats; Rats, Sprague-Dawl

2022
GABA
    Molecules (Basel, Switzerland), 2021, Nov-24, Volume: 26, Issue:23

    Topics: Acids; Animals; Bicuculline; Caffeine; Cyclohexenes; Disease Models, Animal; Electroencephalography;

2021
Lower dACC glutamate in cannabis users during early phase abstinence.
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2022, Volume: 47, Issue:11

    Topics: Cannabinoid Receptor Agonists; Cannabis; Dronabinol; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus C

2022
The Positive Effects of
    International journal of environmental research and public health, 2022, 05-29, Volume: 19, Issue:11

    Topics: Animals; Caffeine; gamma-Aminobutyric Acid; Mice; Mice, Inbred ICR; Plant Extracts; Quality of Life;

2022
Effective Components and Molecular Mechanism of Agarwood Essential Oil Inhalation and the Sedative and Hypnotic Effects Based on GC-MS-Qtof and Molecular Docking.
    Molecules (Basel, Switzerland), 2022, May-28, Volume: 27, Issue:11

    Topics: Animals; Fenclonine; gamma-Aminobutyric Acid; Gas Chromatography-Mass Spectrometry; Glutamic Acid; H

2022
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
Sedative-hypnotic effects of Boropinol-B on mice via activation of GABAA receptors.
    The Journal of pharmacy and pharmacology, 2023, Jan-31, Volume: 75, Issue:1

    Topics: Animals; gamma-Aminobutyric Acid; Hypnotics and Sedatives; Mice; Pentobarbital; Rats; Receptors, GAB

2023
The Effect of Chinese Agarwood Essential Oil with Cyclodextrin Inclusion against PCPA-Induced Insomnia Rats.
    Molecules (Basel, Switzerland), 2023, Jan-07, Volume: 28, Issue:2

    Topics: Animals; Cyclodextrins; Fenclonine; gamma-Aminobutyric Acid; Neurotransmitter Agents; Oils, Volatile

2023
Efficacy and safety of lemborexant as an alternative drug for patients with insomnia taking gamma-aminobutyric acid-benzodiazepine receptor agonists or suvorexant.
    Human psychopharmacology, 2023, Volume: 38, Issue:3

    Topics: gamma-Aminobutyric Acid; Humans; Receptors, GABA-A; Retrospective Studies; Sleep Initiation and Main

2023
Electroacupuncture of the cymba concha alleviates p-chlorophenylalanine-induced insomnia in mice.
    Acupuncture in medicine : journal of the British Medical Acupuncture Society, 2023, Volume: 41, Issue:6

    Topics: Animals; Electroacupuncture; Fenclonine; gamma-Aminobutyric Acid; Hypothalamus; Mice; Sleep Initiati

2023
Sleep-promoting activity of amylase-treated Ashwagandha (Withania somnifera L. Dunal) root extract via GABA receptors.
    Journal of food and drug analysis, 2023, 06-15, Volume: 31, Issue:2

    Topics: Amylases; gamma-Aminobutyric Acid; Pentobarbital; Plant Extracts; Receptors, GABA; Sleep; Sleep Init

2023
Effects of aqueous extracts and volatile oils prepared from Huaxiang Anshen decoction on p-chlorophenylalanine-induced insomnia mice.
    Journal of ethnopharmacology, 2024, Jan-30, Volume: 319, Issue:Pt 3

    Topics: Animals; beta-Cyclodextrins; Dopamine; Fenclonine; gamma-Aminobutyric Acid; Hypnotics and Sedatives;

2024
Sedative and hypnotic effects of compound Anshen essential oil inhalation for insomnia.
    BMC complementary and alternative medicine, 2019, Nov-11, Volume: 19, Issue:1

    Topics: Administration, Inhalation; Animals; Aromatherapy; Brain; Citrus sinensis; Female; gamma-Aminobutyri

2019
Beneficial effect of GABA-rich fermented milk on insomnia involving regulation of gut microbiota.
    Microbiological research, 2020, Volume: 233

    Topics: Animals; Cultured Milk Products; Fatty Acids, Volatile; gamma-Aminobutyric Acid; Gastrointestinal Mi

2020
    Journal of affective disorders, 2020, 09-01, Volume: 274

    Topics: Adult; Depression; Depressive Disorder, Major; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus Cinguli

2020
Sedative and hypnotic effects of Perilla frutescens essential oil through GABAergic system pathway.
    Journal of ethnopharmacology, 2021, Oct-28, Volume: 279

    Topics: Administration, Inhalation; Animals; Disease Models, Animal; Female; gamma-Aminobutyric Acid; Gas Ch

2021
Low-Dose Ozone Therapy Improves Sleep Quality in Patients with Insomnia and Coronary Heart Disease by Elevating Serum BDNF and GABA.
    Bulletin of experimental biology and medicine, 2021, Volume: 170, Issue:4

    Topics: Brain-Derived Neurotrophic Factor; Catalase; Coronary Disease; Depression; gamma-Aminobutyric Acid;

2021
Enzymolysis peptides from Mauremys mutica plastron improve the disorder of neurotransmitter system and facilitate sleep-promoting in the PCPA-induced insomnia mice.
    Journal of ethnopharmacology, 2021, Jun-28, Volume: 274

    Topics: Animals; Brain; Brain-Derived Neurotrophic Factor; Dopamine; gamma-Aminobutyric Acid; Hypnotics and

2021
Molecular Regulation of Betulinic Acid on α3β4 Nicotinic Acetylcholine Receptors.
    Molecules (Basel, Switzerland), 2021, May-01, Volume: 26, Issue:9

    Topics: Acetylcholine; Animals; Betulinic Acid; Binding Sites; Cattle; Electrophysiology; gamma-Aminobutyric

2021
The dual orexin receptor antagonist, DORA-22, lowers histamine levels in the lateral hypothalamus and prefrontal cortex without lowering hippocampal acetylcholine.
    Journal of neurochemistry, 2017, Volume: 142, Issue:2

    Topics: Acetylcholine; Animals; gamma-Aminobutyric Acid; Hippocampus; Histamine; Hypothalamic Area, Lateral;

2017
The Effect of sequential bilateral low-frequency rTMS over dorsolateral prefrontal cortex on serum level of BDNF and GABA in patients with primary insomnia.
    Brain and behavior, 2019, Volume: 9, Issue:2

    Topics: Adult; Brain-Derived Neurotrophic Factor; Correlation of Data; Female; gamma-Aminobutyric Acid; Huma

2019
Structure: the anatomy of sleep.
    Nature, 2013, May-23, Volume: 497, Issue:7450

    Topics: Adolescent; Adult; Child; gamma-Aminobutyric Acid; Humans; Infant, Newborn; Sleep; Sleep Initiation

2013
Discovery of novel insomnia leads from screening traditional Chinese medicine database.
    Journal of biomolecular structure & dynamics, 2014, Volume: 32, Issue:5

    Topics: Binding Sites; Caffeic Acids; Citric Acid; Coumaric Acids; Databases, Chemical; Drugs, Chinese Herba

2014
Treatment-resistant insomnia treated with pregabalin.
    European review for medical and pharmacological sciences, 2013, Volume: 17, Issue:11

    Topics: Female; gamma-Aminobutyric Acid; Humans; Middle Aged; Pregabalin; Restless Legs Syndrome; Sleep Init

2013
[Effects of extracts from ziziphi spinosae semen and schisandrae chinensis fructus on amino acid neurotransmitter in rats with insomnia induced by PCPA].
    Zhong yao cai = Zhongyaocai = Journal of Chinese medicinal materials, 2013, Volume: 36, Issue:10

    Topics: Animals; Disease Models, Animal; Drugs, Chinese Herbal; Female; Fenclonine; Fruit; gamma-Aminobutyri

2013
Cortical gamma-aminobutyric acid and glutamate in posttraumatic stress disorder and their relationships to self-reported sleep quality.
    Sleep, 2014, May-01, Volume: 37, Issue:5

    Topics: Arousal; Aspartic Acid; Cerebral Cortex; gamma-Aminobutyric Acid; Glutamic Acid; Gyrus Cinguli; Huma

2014
[Mechanism of Bailemian capsules in the treatment of insomnia in mice].
    Zhonghua yi xue za zhi, 2014, Dec-16, Volume: 94, Issue:46

    Topics: Animals; Capsules; gamma-Aminobutyric Acid; Injections, Intraperitoneal; Mice; Serotonin; Sleep; Sle

2014
Magnetic Resonance Spectroscopy in Patients with Insomnia: A Repeated Measurement Study.
    PloS one, 2016, Volume: 11, Issue:6

    Topics: Adult; Brain; Brain Chemistry; Case-Control Studies; Female; gamma-Aminobutyric Acid; Glutamic Acid;

2016
Insomnia may increase anesthetic requirement.
    Journal of clinical anesthesia, 2016, Volume: 34

    Topics: Abdominal Pain; Adult; Anesthetics, Inhalation; Carbon Dioxide; Cholecystectomy, Laparoscopic; Consc

2016
What is the effective component in suanzaoren decoction for curing insomnia? Discovery by virtual screening and molecular dynamic simulation.
    Journal of biomolecular structure & dynamics, 2008, Volume: 26, Issue:1

    Topics: Binding Sites; Blood-Brain Barrier; Brain; Computer Simulation; Drugs, Chinese Herbal; gamma-Aminobu

2008
Reduced brain GABA in primary insomnia: preliminary data from 4T proton magnetic resonance spectroscopy (1H-MRS).
    Sleep, 2008, Volume: 31, Issue:11

    Topics: Adult; alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid; Brain; Cross-Sectional Studies; Dia

2008
GABA tea helps sleep.
    Journal of alternative and complementary medicine (New York, N.Y.), 2009, Volume: 15, Issue:7

    Topics: Adult; Camellia sinensis; gamma-Aminobutyric Acid; Humans; Male; Phytotherapy; Plant Extracts; Sleep

2009
Paroxysmal arousals and myoclonic movements associated with interictal epileptiform discharges in NREM and REM sleep.
    Clinical neurology and neurosurgery, 2011, Volume: 113, Issue:5

    Topics: Adolescent; Amines; Antiparkinson Agents; Arousal; Chromosome Disorders; Chromosome Inversion; Chrom

2011
Reduced γ-aminobutyric acid in occipital and anterior cingulate cortices in primary insomnia: a link to major depressive disorder?
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2012, Volume: 37, Issue:6

    Topics: Actigraphy; Adult; Brain Mapping; Case-Control Studies; Creatine; Depressive Disorder, Major; Female

2012
Nighttime awakenings responding to gabapentin therapy in late premenopausal women: a case series.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2012, Apr-15, Volume: 8, Issue:2

    Topics: Adult; Amines; Anti-Anxiety Agents; Cyclohexanecarboxylic Acids; Estradiol; Female; Follicle Stimula

2012
The role of GABA in primary insomnia.
    Sleep, 2012, Jun-01, Volume: 35, Issue:6

    Topics: Brain Chemistry; Female; gamma-Aminobutyric Acid; Humans; Male; Sleep Initiation and Maintenance Dis

2012
Cortical GABA levels in primary insomnia.
    Sleep, 2012, Jun-01, Volume: 35, Issue:6

    Topics: Adult; Brain Chemistry; Case-Control Studies; Female; gamma-Aminobutyric Acid; Humans; Magnetic Reso

2012
Gabapentin shows promise in treating refractory insomnia in children.
    Journal of child neurology, 2013, Volume: 28, Issue:12

    Topics: Adolescent; Amines; Anticonvulsants; Child; Child, Preschool; Cyclohexanecarboxylic Acids; Female; F

2013
[Effect of acupuncture at different acupoints on expression of hypothalamic GABA and GABA(A) receptor proteins in insomnia rats].
    Zhen ci yan jiu = Acupuncture research, 2012, Volume: 37, Issue:4

    Topics: Acupuncture Points; Acupuncture Therapy; Animals; Disease Models, Animal; gamma-Aminobutyric Acid; H

2012
Gabapentin efficacy in reducing nighttime awakenings in premenopausal women: a class effect of GABAergic medications or unique property of gabapentin only?
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2012, Dec-15, Volume: 8, Issue:6

    Topics: Amines; Anti-Anxiety Agents; Cyclohexanecarboxylic Acids; Female; gamma-Aminobutyric Acid; Humans; P

2012
Hyperalgesia induced by REM sleep loss: a phenomenon in search of a mechanism.
    Sleep, 2006, Volume: 29, Issue:2

    Topics: Acetylcholine; Adenosine; Anxiety; Chronic Disease; Depression; Drug Therapy; Drug-Related Side Effe

2006
Cellular mechanisms of benzodiazepine action.
    JAMA, 1982, Apr-16, Volume: 247, Issue:15

    Topics: Animals; Anti-Anxiety Agents; Anxiety; Benzodiazepines; gamma-Aminobutyric Acid; Humans; Mice; Model

1982
Removal of GABAergic inhibition in the mediodorsal nucleus of the rat thalamus leads to increases in heart rate and blood pressure.
    Neuroscience letters, 1998, May-15, Volume: 247, Issue:2-3

    Topics: Animals; Autonomic Nervous System Diseases; Bicuculline; Blood Pressure; GABA Antagonists; GABA-A Re

1998
GABAA alpha-1 subunit gene not associated with depressive symptomatology in mood disorders.
    Psychiatric genetics, 1998,Winter, Volume: 8, Issue:4

    Topics: Adult; Anxiety; Bipolar Disorder; Delusions; Depression; DNA; Female; gamma-Aminobutyric Acid; Genet

1998
Selective neuronal vulnerability in human prion diseases. Fatal familial insomnia differs from other types of prion diseases.
    The American journal of pathology, 1999, Volume: 155, Issue:5

    Topics: Adult; Brain; Female; gamma-Aminobutyric Acid; Humans; Immunohistochemistry; Male; Middle Aged; Neur

1999
Stress-induced insomnia: opioid-dopamine interactions.
    European journal of pharmacology, 1987, Oct-27, Volume: 142, Issue:3

    Topics: 2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine; Animals; Antipsychotic Agents; Appetite

1987