mirtazapine has been researched along with Chronic Insomnia in 48 studies
Mirtazapine: A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
| Excerpt | Relevance | Reference |
|---|---|---|
| "In the present study mirtazapine rapidly improved nausea, sleep disturbance, pain and quality of life, as well as depression in cancer patients." | 9.13 | Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. ( Kim, JM; Kim, KM; Kim, KS; Kim, SW; Kim, YC; Shin, IS; Yang, SJ; Yoon, JS, 2008) |
| " Here, we report the case of a 20-year-old man with severe social anxiety disorder, major depressive disorder, insomnia and attenuated psychotic symptoms despite ongoing treatment with cognitive behavioural therapy and mirtazapine who was treated with adjunctive cannabidiol (CBD) in doses between 200 and 800 mg/day for 6 months." | 7.96 | Treatment of social anxiety disorder and attenuated psychotic symptoms with cannabidiol. ( Amminger, GP; Berger, M; Li, E, 2020) |
| " This report presents the beneficial effect of low-dose mirtazapine added onto selective serotonin reuptake inhibitors in the treatment of the symptoms of severe nausea, insomnia and loss of appetite accompanying psychiatric disorders during pregnancy, which is an important problem in clinical practice." | 7.79 | Low-dose mirtazapine added to selective serotonin reuptake inhibitors in pregnant women with major depression or panic disorder including symptoms of severe nausea, insomnia and decreased appetite: three cases. ( Uguz, F, 2013) |
| "Mirtazapine is an antidepressant that has a receptor-binding profile that may suit it for use in controlling the nausea and insomnia of highly emetic cancer chemotherapy." | 7.71 | Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy. ( Kast, RE, 2001) |
| "To describe the role of mirtazapine in the treatment of depressed Alzheimer patients with comorbid weight loss, insomnia, and anxiety." | 7.71 | Mirtazapine for treatment of depression and comorbidities in Alzheimer disease. ( Brady, SR; Raji, MA, 2001) |
| " In addition, a dose-response effect was seen with Org 3770, 15 mg seeming optimal." | 6.66 | A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery. ( Bettum, V; Dunbar, GC; Jørgensen, J; Steffensen, K; Sørensen, M; Viby-Mogensen, J, 1985) |
| "In the present study mirtazapine rapidly improved nausea, sleep disturbance, pain and quality of life, as well as depression in cancer patients." | 5.13 | Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. ( Kim, JM; Kim, KM; Kim, KS; Kim, SW; Kim, YC; Shin, IS; Yang, SJ; Yoon, JS, 2008) |
| "The aim of this study was to conduct a naturalistic, open-label examination of the efficacy and tolerability of mirtazapine (a medication with both serotonergic and noradrenergic properties) in the treatment of associated symptoms of autism and other pervasive developmental disorders (PDDs)." | 5.09 | A naturalistic open-label study of mirtazapine in autistic and other pervasive developmental disorders. ( Guenin, KD; Kohn, AE; McDougle, CJ; Posey, DJ; Swiezy, NB, 2001) |
| " Here, we report the case of a 20-year-old man with severe social anxiety disorder, major depressive disorder, insomnia and attenuated psychotic symptoms despite ongoing treatment with cognitive behavioural therapy and mirtazapine who was treated with adjunctive cannabidiol (CBD) in doses between 200 and 800 mg/day for 6 months." | 3.96 | Treatment of social anxiety disorder and attenuated psychotic symptoms with cannabidiol. ( Amminger, GP; Berger, M; Li, E, 2020) |
| " This report presents the beneficial effect of low-dose mirtazapine added onto selective serotonin reuptake inhibitors in the treatment of the symptoms of severe nausea, insomnia and loss of appetite accompanying psychiatric disorders during pregnancy, which is an important problem in clinical practice." | 3.79 | Low-dose mirtazapine added to selective serotonin reuptake inhibitors in pregnant women with major depression or panic disorder including symptoms of severe nausea, insomnia and decreased appetite: three cases. ( Uguz, F, 2013) |
| "To describe the role of mirtazapine in the treatment of depressed Alzheimer patients with comorbid weight loss, insomnia, and anxiety." | 3.71 | Mirtazapine for treatment of depression and comorbidities in Alzheimer disease. ( Brady, SR; Raji, MA, 2001) |
| "Mirtazapine is an antidepressant that has a receptor-binding profile that may suit it for use in controlling the nausea and insomnia of highly emetic cancer chemotherapy." | 3.71 | Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy. ( Kast, RE, 2001) |
| "Adults (18-85 years) with insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders-5) who ask their general practitioner (GP) for sleep medication when non-pharmacological treatment is deemed not effective, are eligible." | 3.01 | Effectiveness of low-dose amitriptyline and mirtazapine for insomnia disorder: study protocol of a randomised, double-blind, placebo-controlled trial in general practice (the DREAMING study). ( Bakker, MH; Hugtenburg, JG; Slottje, P; van der Horst, HE; van Straten, A, 2021) |
| " Esmirtazapine was generally well tolerated; somnolence and weight gain were the most common adverse events." | 2.94 | Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. ( Braat, S; Chang, Q; Hajak, G; Ivgy-May, N; Roth, T; van Osta, G, 2020) |
| "Patients aged 18 to 65 years with primary insomnia were randomized to receive placebo or 1." | 2.82 | A Phase 2 Randomized Dose-Finding Study With Esmirtazapine in Patients With Primary Insomnia. ( IJzerman-Boon, P; Ivgy-May, N; Roth, T; Ruwe, F; Zammit, G, 2016) |
| "Those with pre-treatment insomnia were more likely to be female (69." | 2.80 | Pre-treatment insomnia as a predictor of single and combination antidepressant outcomes: a CO-MED report. ( Luther, JF; Rush, AJ; Sung, SC; Trivedi, MH; Wisniewski, SR, 2015) |
| " Overall, 35-42% of esmirtazapine-treated patients had adverse events (AEs) versus 29% in the placebo group." | 2.80 | Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. ( Ivgy-May, N; Krystal, A; Roth, T; Ruwe, F, 2015) |
| " Measures to assess the potential adverse effects of treatment included morning alertness, daytime function/napping, and rebound insomnia during a single-blind placebo run-out week after treatment ended." | 2.80 | Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. ( Ivgy-May, N; Roth, T; Ruwe, F; Walsh, J, 2015) |
| " Mirtazapine in fixed and ascending nocturnal dosing regimens was found to facilitate sleep, but it does not generally reduce daytime alertness." | 2.69 | Mirtazapine effects on alertness and sleep in patients as recorded by interactive telecommunication during treatment with different dosing regimens. ( O'Hanlon, JF; Radhakishun, FS; Roes, KC; van den Bos, J; van der Heijden, BC, 2000) |
| " In addition, a dose-response effect was seen with Org 3770, 15 mg seeming optimal." | 2.66 | A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery. ( Bettum, V; Dunbar, GC; Jørgensen, J; Steffensen, K; Sørensen, M; Viby-Mogensen, J, 1985) |
| "The latter yielded results on VMS, insomnia, circadian rhythm disorders, obstructive sleep apnea (OSA) and restless leg syndrome (RLS)." | 2.61 | Italian Association of Sleep Medicine (AIMS) position statement and guideline on the treatment of menopausal sleep disorders. ( Aricò, I; Bonanni, E; Bonsignore, M; Caretto, M; Caruso, D; Di Perri, MC; Galletta, S; Lecca, RM; Lombardi, C; Maestri, M; Miccoli, M; Palagini, L; Provini, F; Puligheddu, M; Savarese, M; Silvestri, R; Simoncini, T; Spaggiari, MC, 2019) |
| "Such approach to treatment of insomnia in depressed patients protects them against dependence on hypnotic drugs." | 2.47 | [The effects of antidepressants on sleep in depressed patients with particular reference to trazodone in comparison to agomelatine, amitriptyline, doxepin, mianserine and mirtazapine]. ( Wichniak, A; Wierzbicka, A, 2011) |
| "Mirtazapine is an effective antidepressant with unique and special mechanism of action characterized by high response and remission rates, relatively early onest of action and favourable side-effect profile." | 2.45 | [Mirtazapine--pharmacologic action and clinical advantages]. ( Purebl, G; Rihmer, Z, 2009) |
| "The prevalence of insomnia increases with age and affects up to 35% of community-dwelling adults with dementia." | 2.45 | Non-pharmacologic treatment of insomnia in persons with dementia. ( Darvishi, R; Kunik, ME; Shub, D, 2009) |
| "Insomnia and daytime sleepiness are often associated with depression." | 2.42 | Daytime sleepiness and insomnia as correlates of depression. ( Fava, M, 2004) |
| " The rates for individual side effects with the serotonin selective reuptake inhibitors, nefazodone, and venlafaxine are presented and compared with the adverse event experience for mirtazapine." | 2.40 | Safety and tolerability of the new antidepressants. ( Nelson, JC, 1997) |
| "Insomnia is a particularly frequent complaint, and it is reported by more than 90% of depressed patients." | 2.40 | Antidepressant treatment of the depressed patient with insomnia. ( Thase, ME, 1999) |
| "Mirtazapine is a Food and Drug Administration-approved atypical antidepressant used off-label for insomnia." | 1.91 | A 9-year-old female with iron deficiency has severe periodic limb movements while taking mirtazapine for insomnia. ( Hawkins, M, 2023) |
| "Acquired neuromyotonia manifests clinically in cramps, fasciculations, and stiffness." | 1.42 | Neuromyotonia with polyneuropathy, prominent psychoorganic syndrome, insomnia, and suicidal behavior without antibodies: a case report. ( Ehler, E; Meleková, A, 2015) |
| "In 3,455 MDD outpatients with insomnia after treatment, the reduction of sleep latency (P < 0." | 1.40 | Real-world, open-label study to evaluate the effectiveness of mirtazapine on sleep quality in outpatients with major depressive disorder. ( Hao, W; Li, L; Li, Z; Wang, D, 2014) |
| " Mirtazapine is a commonly prescribed antidepressant drug, which is also metabolized through and may modulate the CYP4502D6 pathway leading to altered metabolism of propafenone and possible adverse effects." | 1.40 | Propafenone associated severe central nervous system and cardiovascular toxicity due to mirtazapine: a case of severe drug interaction. ( Aryal, SR; Khan, MA; Rajpurohit, N; Stys, AT; Stys, TP, 2014) |
| "Mirtazapine was administered for eight weeks to the 101 patients who completed the study, during which we evaluated the clinical outcome using repeated-measures ANCOVA." | 1.34 | Effect of serotonin receptor 2A gene polymorphism on mirtazapine response in major depression. ( Choi, MJ; Hahn, SW; Kang, RH; Lee, MS; Paik, JW, 2007) |
| "Six patients meeting criteria for major depressive disorder and scoring > or =4 on the three Hamilton Depression Rating Scale sleep items were studied." | 1.31 | Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study. ( Bayles-Dazet, W; Gary, KA; Hayes, JB; MacDonald, MM; Sateia, MJ; Winokur, A, 2000) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (2.08) | 18.7374 |
| 1990's | 3 (6.25) | 18.2507 |
| 2000's | 22 (45.83) | 29.6817 |
| 2010's | 15 (31.25) | 24.3611 |
| 2020's | 7 (14.58) | 2.80 |
| Authors | Studies |
|---|---|
| Bakker, MH | 1 |
| Hugtenburg, JG | 1 |
| van Straten, A | 1 |
| van der Horst, HE | 1 |
| Slottje, P | 1 |
| Wu, S | 1 |
| Lin, M | 1 |
| Rice, T | 1 |
| Coffey, BJ | 1 |
| Hawkins, M | 1 |
| Silvestri, R | 1 |
| Aricò, I | 1 |
| Bonanni, E | 1 |
| Bonsignore, M | 1 |
| Caretto, M | 1 |
| Caruso, D | 1 |
| Di Perri, MC | 1 |
| Galletta, S | 1 |
| Lecca, RM | 1 |
| Lombardi, C | 1 |
| Maestri, M | 1 |
| Miccoli, M | 1 |
| Palagini, L | 1 |
| Provini, F | 1 |
| Puligheddu, M | 1 |
| Savarese, M | 1 |
| Spaggiari, MC | 1 |
| Simoncini, T | 1 |
| Ivgy-May, N | 5 |
| Hajak, G | 1 |
| van Osta, G | 1 |
| Braat, S | 1 |
| Chang, Q | 1 |
| Roth, T | 4 |
| Berger, M | 1 |
| Li, E | 1 |
| Amminger, GP | 1 |
| Sangal, RB | 1 |
| Gandotra, K | 1 |
| Chen, P | 1 |
| Jaskiw, GE | 1 |
| Konicki, PE | 1 |
| Strohl, KP | 1 |
| Hairston, DR | 1 |
| de Similien, RH | 1 |
| Himelhoch, S | 1 |
| Forrester, A | 1 |
| Wang, D | 1 |
| Li, Z | 1 |
| Li, L | 1 |
| Hao, W | 1 |
| Rajpurohit, N | 1 |
| Aryal, SR | 1 |
| Khan, MA | 1 |
| Stys, AT | 1 |
| Stys, TP | 1 |
| Sung, SC | 1 |
| Wisniewski, SR | 1 |
| Luther, JF | 1 |
| Trivedi, MH | 1 |
| Rush, AJ | 1 |
| Ehler, E | 1 |
| Meleková, A | 1 |
| Ruwe, F | 3 |
| Walsh, J | 1 |
| Krystal, A | 1 |
| IJzerman-Boon, P | 1 |
| Zammit, G | 1 |
| Karsten, J | 1 |
| Hagenauw, LA | 1 |
| Kamphuis, J | 1 |
| Lancel, M | 1 |
| Shub, D | 1 |
| Darvishi, R | 1 |
| Kunik, ME | 1 |
| Rihmer, Z | 1 |
| Purebl, G | 1 |
| Dolev, Z | 1 |
| Wichniak, A | 1 |
| Wierzbicka, A | 1 |
| Clark, MS | 1 |
| Smith, PO | 1 |
| Jamieson, B | 1 |
| Uguz, F | 1 |
| Lewis, JD | 1 |
| Winokur, A | 2 |
| DeMartinis, NA | 1 |
| McNally, DP | 1 |
| Gary, EM | 1 |
| Cormier, JL | 1 |
| Gary, KA | 2 |
| Lawrence, RW | 1 |
| Pallanti, S | 1 |
| Quercioli, L | 1 |
| Bruscoli, M | 1 |
| Fava, M | 1 |
| Wingen, M | 1 |
| Bothmer, J | 1 |
| Langer, S | 1 |
| Ramaekers, JG | 1 |
| Shen, J | 1 |
| Chung, SA | 1 |
| Kayumov, L | 1 |
| Moller, H | 1 |
| Hossain, N | 1 |
| Wang, X | 1 |
| Deb, P | 1 |
| Sun, F | 1 |
| Huang, X | 1 |
| Novak, M | 1 |
| Appleton, D | 1 |
| Shapiro, CM | 1 |
| Adler, LA | 1 |
| Reingold, LS | 1 |
| Morrill, MS | 1 |
| Wilens, TE | 1 |
| Fusar-Poli, P | 1 |
| Matteo, L | 1 |
| Luca, de M | 1 |
| Politi, P | 1 |
| Cortesi, M | 1 |
| Carboni, V | 1 |
| Prospero-Garcia, KA | 1 |
| Torres-Ruiz, A | 1 |
| Ramirez-Bermudez, J | 1 |
| Velazquez-Moctezuma, J | 1 |
| Arana-Lechuga, Y | 1 |
| Teran-Perez, G | 1 |
| Tuya, AC | 1 |
| Kim, SW | 1 |
| Shin, IS | 1 |
| Kim, JM | 1 |
| Kim, YC | 1 |
| Kim, KS | 1 |
| Kim, KM | 1 |
| Yang, SJ | 1 |
| Yoon, JS | 1 |
| Kang, RH | 1 |
| Choi, MJ | 1 |
| Paik, JW | 1 |
| Hahn, SW | 1 |
| Lee, MS | 1 |
| Nelson, JC | 1 |
| Thase, ME | 2 |
| Davis, J | 1 |
| Barkin, RL | 1 |
| Sateia, MJ | 1 |
| Hayes, JB | 1 |
| Bayles-Dazet, W | 1 |
| MacDonald, MM | 1 |
| Radhakishun, FS | 1 |
| van den Bos, J | 1 |
| van der Heijden, BC | 1 |
| Roes, KC | 1 |
| O'Hanlon, JF | 1 |
| Raji, MA | 1 |
| Brady, SR | 1 |
| Kast, RE | 1 |
| Posey, DJ | 1 |
| Guenin, KD | 1 |
| Kohn, AE | 1 |
| Swiezy, NB | 1 |
| McDougle, CJ | 1 |
| Sørensen, M | 1 |
| Jørgensen, J | 1 |
| Viby-Mogensen, J | 1 |
| Bettum, V | 1 |
| Dunbar, GC | 1 |
| Steffensen, K | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia[NCT00631657] | Phase 3 | 460 participants (Actual) | Interventional | 2008-03-04 | Completed | ||
| A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106[NCT00750919] | Phase 3 | 184 participants (Actual) | Interventional | 2008-10-07 | Terminated (stopped due to This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.) | ||
| A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia[NCT00482612] | Phase 3 | 526 participants (Actual) | Interventional | 2006-12-07 | Completed | ||
| A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial With Org 50081 in Patients With Chronic Primary Insomnia[NCT00506389] | Phase 3 | 419 participants (Actual) | Interventional | 2007-06-06 | Completed | ||
| Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea[NCT05303935] | Phase 2 | 15 participants (Actual) | Interventional | 2022-05-25 | Completed | ||
| Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods[NCT03676491] | 112 participants (Actual) | Interventional | 2018-05-23 | Completed | |||
| Antidepressant Response to a Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder[NCT00385437] | Phase 2 | 16 participants | Interventional | 2003-04-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment. (NCT00631657)
Timeframe: Baseline and Week 26
| Intervention | score on a scale (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | -2.1 |
| Placebo | -1.4 |
The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment. (NCT00631657)
Timeframe: Baseline and End of 7-day Discontinuation Period
| Intervention | score on a scale (Mean) |
|---|---|
| Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg | 0.3 |
| Esmirtazapine 4.5 mg/Placebo | 0.5 |
| Placebo/Placebo | 0.0 |
"NAW was defined as the number of times recorded for sleep diary question 4a How many times did you wake up during the night?, as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | number of awakenings (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | -0.8 |
| Placebo | -0.5 |
"Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 How satisfied are you about your sleep duration of last night?, as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | score on a scale (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | 18.3 |
| Placebo | 7.2 |
"SL was defined as the time recorded for sleep diary question 3 How long did it take you to fall asllep?, as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | minutes (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | -29.7 |
| Placebo | -26.9 |
"Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 Rate the quality of your sleep last night, as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | score on a scale (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | 16.1 |
| Placebo | 5.8 |
"TST was defined as the time recorded for sleep diary question 6 How much time did you actually spend sleeping? as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | minutes (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | 65.9 |
| Placebo | 19.3 |
"WASO was defined as the time recorded for sleep diary question 5 How much time were you awake, after falling asleep initially?, as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach." (NCT00631657)
Timeframe: Baseline and the Mean of Weeks 14-26
| Intervention | minutes (Mean) |
|---|---|
| Esmirtazapine 4.5 mg | -46.4 |
| Placebo | -20.8 |
An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period. (NCT00631657)
Timeframe: Up to 27 weeks
| Intervention | participants (Number) |
|---|---|
| Esmirtazapine 4.5 mg | 47 |
| Placebo | 7 |
An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period. (NCT00631657)
Timeframe: Up to 31 weeks
| Intervention | participants (Number) |
|---|---|
| Esmirtazapine 4.5 mg | 253 |
| Placebo | 75 |
SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization. (NCT00631657)
Timeframe: Baseline and Week 26
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Change from BL at Week 26 - PCS | Change from BL at Week 26 - MCS | |
| Esmirtazapine 4.5 mg | 1.6 | 4.6 |
| Placebo | -0.2 | 4.5 |
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00750919)
Timeframe: Up to 26 weeks
| Intervention | Participants (Number) |
|---|---|
| Esmirtazapine | 9 |
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00750919)
Timeframe: Up to 30 weeks
| Intervention | Participants (Number) |
|---|---|
| Esmirtazapine | 127 |
"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep', as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed." (NCT00750919)
Timeframe: Baseline and Week 26
| Intervention | Minutes per night (Mean) | |
|---|---|---|
| Baseline measure (n=184) | Change from baseline at Week 26 (n=123) | |
| Esmirtazapine | 38.7 | -1.5 |
"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed." (NCT00750919)
Timeframe: Baseline and Week 26
| Intervention | Minutes per night (Mean) | |
|---|---|---|
| Baseline measure (n=184) | Change from baseline at Week 26 (n=123) | |
| Esmirtazapine | 368.1 | 9.7 |
"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed." (NCT00750919)
Timeframe: Baseline and Week 26
| Intervention | Minutes per night (Mean) | |
|---|---|---|
| Baseline measure (n=184) | Change from baseline at Week 26 (n=123) | |
| Esmirtazapine | 40.0 | -5.4 |
SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis. (NCT00482612)
Timeframe: Day 1 to Day 15
| Intervention | Minutes (Mean) |
|---|---|
| Esmirtazapine 1.5 mg | 48.93 |
| Esmirtazapine 3.0 mg | 52.02 |
| Esmirtazapine 4.5 mg | 50.80 |
| Placebo | 60.13 |
TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis. (NCT00482612)
Timeframe: Day 1 to Day 15
| Intervention | Minutes (Mean) |
|---|---|
| Esmirtazapine 1.5 mg | 382.14 |
| Esmirtazapine 3.0 mg | 382.77 |
| Esmirtazapine 4.5 mg | 394.83 |
| Placebo | 351.40 |
The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT00482612)
Timeframe: Day 1 to Day 15
| Intervention | Number of participants (Number) |
|---|---|
| Esmirtazapine 1.5 mg | 35 |
| Esmirtazapine 3.0 mg | 41 |
| Esmirtazapine 4.5 mg | 41 |
| Placebo | 28 |
The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT00482612)
Timeframe: Day 1 to Day 15
| Intervention | Number of participants (Number) |
|---|---|
| Esmirtazapine 1.5 mg | 4 |
| Esmirtazapine 3.0 mg | 7 |
| Esmirtazapine 4.5 mg | 9 |
| Placebo | 0 |
LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36. (NCT00506389)
Timeframe: From Day 1 to Day 36
| Intervention | Minutes (Mean) |
|---|---|
| Esmirtazapine 3.0 mg | 28.7 |
| Esmirtazapine 4.5 mg | 26.1 |
| Placebo | 40.5 |
TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis. (NCT00506389)
Timeframe: From Day 1 to Day 36
| Intervention | Minutes (Mean) |
|---|---|
| Esmirtazapine 3.0 mg | 384.6 |
| Esmirtazapine 4.5 mg | 384.6 |
| Placebo | 351.6 |
WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36. (NCT00506389)
Timeframe: From Day 1 to Day 36
| Intervention | Minutes (Mean) |
|---|---|
| Esmirtazapine 3.0 mg | 45.6 |
| Esmirtazapine 4.5 mg | 45.5 |
| Placebo | 76.1 |
8 reviews available for mirtazapine and Chronic Insomnia
| Article | Year |
|---|---|
Italian Association of Sleep Medicine (AIMS) position statement and guideline on the treatment of menopausal sleep disorders.
Topics: Antidepressive Agents; Cognitive Behavioral Therapy; Continuous Positive Airway Pressure; Depression | 2019 |
Non-pharmacologic treatment of insomnia in persons with dementia.
Topics: Aged; Aged, 80 and over; Aging; Alzheimer Disease; Antidepressive Agents, Tricyclic; Circadian Rhyth | 2009 |
[Mirtazapine--pharmacologic action and clinical advantages].
Topics: Adrenergic alpha-Antagonists; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Depress | 2009 |
[The effects of antidepressants on sleep in depressed patients with particular reference to trazodone in comparison to agomelatine, amitriptyline, doxepin, mianserine and mirtazapine].
Topics: Amitriptyline; Antidepressive Agents; Depression; Doxepin; Humans; Mianserin; Mirtazapine; Sleep; Sl | 2011 |
Daytime sleepiness and insomnia as correlates of depression.
Topics: Antidepressive Agents; Benzhydryl Compounds; Bupropion; Comorbidity; Depressive Disorder; Disorders | 2004 |
Safety and tolerability of the new antidepressants.
Topics: Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Cyclohexanols; Depressiv | 1997 |
Antidepressant treatment of the depressed patient with insomnia.
Topics: Antidepressive Agents, Tricyclic; Comorbidity; Cyclohexanols; Depressive Disorder; Fluoxetine; Human | 1999 |
Treatment issues related to sleep and depression.
Topics: Antidepressive Agents; Antidepressive Agents, Tricyclic; Comorbidity; Depressive Disorder; Humans; M | 2000 |
16 trials available for mirtazapine and Chronic Insomnia
| Article | Year |
|---|---|
Effectiveness of low-dose amitriptyline and mirtazapine for insomnia disorder: study protocol of a randomised, double-blind, placebo-controlled trial in general practice (the DREAMING study).
Topics: Adult; Amitriptyline; Antidepressive Agents; Double-Blind Method; General Practice; Humans; Mirtazap | 2021 |
Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension.
Topics: Adult; Double-Blind Method; Humans; Mirtazapine; Outpatients; Sleep Initiation and Maintenance Disor | 2020 |
Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension.
Topics: Adult; Double-Blind Method; Humans; Mirtazapine; Outpatients; Sleep Initiation and Maintenance Disor | 2020 |
Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension.
Topics: Adult; Double-Blind Method; Humans; Mirtazapine; Outpatients; Sleep Initiation and Maintenance Disor | 2020 |
Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension.
Topics: Adult; Double-Blind Method; Humans; Mirtazapine; Outpatients; Sleep Initiation and Maintenance Disor | 2020 |
Pre-treatment insomnia as a predictor of single and combination antidepressant outcomes: a CO-MED report.
Topics: Adolescent; Adult; Aged; Antidepressive Agents; Anxiety Disorders; Bupropion; Citalopram; Comorbidit | 2015 |
Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial.
Topics: Adult; Ambulatory Care; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hypno | 2015 |
Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial.
Topics: Adult; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hypnotics and Sedative | 2015 |
A Phase 2 Randomized Dose-Finding Study With Esmirtazapine in Patients With Primary Insomnia.
Topics: Adult; Antidepressive Agents, Tricyclic; Cross-Over Studies; Double-Blind Method; Female; Humans; Ma | 2016 |
Low doses of mirtazapine or quetiapine for transient insomnia: A randomised, double-blind, cross-over, placebo-controlled trial.
Topics: Adolescent; Adult; Antipsychotic Agents; Attention; Cognition; Cross-Over Studies; Double-Blind Meth | 2017 |
Comparative effects of mirtazapine and fluoxetine on sleep physiology measures in patients with major depression and insomnia.
Topics: Adult; Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Depressive Disord | 2003 |
Response acceleration with mirtazapine augmentation of citalopram in obsessive-compulsive disorder patients without comorbid depression: a pilot study.
Topics: Adult; Age of Onset; Antidepressive Agents, Tricyclic; Citalopram; Comorbidity; Depressive Disorder; | 2004 |
Actual driving performance and psychomotor function in healthy subjects after acute and subchronic treatment with escitalopram, mirtazapine, and placebo: a crossover trial.
Topics: Adult; Affect; Antidepressive Agents, Tricyclic; Automobile Driving; Circadian Rhythm; Citalopram; C | 2005 |
Polysomnographic and symptomatological analyses of major depressive disorder patients treated with mirtazapine.
Topics: Adult; Affect; Antidepressive Agents, Tricyclic; Body Weight; Depressive Disorder, Major; Drug Admin | 2006 |
Fluoxetine-mirtazapine interaction may induce restless legs syndrome: report of 3 cases from a clinical trial.
Topics: Adult; Antidepressive Agents; Depressive Disorder, Major; Drug Interactions; Drug Therapy, Combinati | 2006 |
Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression.
Topics: Adjustment Disorders; Administration, Oral; Adult; Aged; Antidepressive Agents, Tricyclic; Depressiv | 2008 |
Mirtazapine effects on alertness and sleep in patients as recorded by interactive telecommunication during treatment with different dosing regimens.
Topics: Affect; Antidepressive Agents, Tricyclic; Attention; Depressive Disorder; Dose-Response Relationship | 2000 |
A naturalistic open-label study of mirtazapine in autistic and other pervasive developmental disorders.
Topics: Adolescent; Adult; Aggression; Antidepressive Agents, Tricyclic; Anxiety Disorders; Appetite; Autist | 2001 |
A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery.
Topics: Adult; Anxiety; Blood Pressure; Diazepam; Dibenzazepines; Dose-Response Relationship, Drug; Double-B | 1985 |
24 other studies available for mirtazapine and Chronic Insomnia
| Article | Year |
|---|---|
Case Report: When Time is of the Essence-Benefits of Mirtazapine in an Adolescent with Major Depressive Disorder and Insomnia, Suicidal Thoughts, and Catatonic Features.
Topics: Adolescent; Depression; Depressive Disorder, Major; Humans; Mirtazapine; Sleep Initiation and Mainte | 2022 |
A 9-year-old female with iron deficiency has severe periodic limb movements while taking mirtazapine for insomnia.
Topics: Adult; Child; Female; Humans; Iron; Iron Deficiencies; Mirtazapine; Nocturnal Myoclonus Syndrome; Re | 2023 |
Treatment of social anxiety disorder and attenuated psychotic symptoms with cannabidiol.
Topics: Adult; Cannabidiol; Cognitive Behavioral Therapy; Depressive Disorder, Major; Depressive Disorder, T | 2020 |
Efficacy and safety of esmirtazapine in adult insomnia: unsupported statements about residual daytime effects.
Topics: Adult; Disease Progression; Humans; Hypnotics and Sedatives; Mirtazapine; Sleep; Sleep Initiation an | 2021 |
Residual daytime effects of esmirtazapine.
Topics: Disease Progression; Double-Blind Method; Humans; Mirtazapine; Sleep Initiation and Maintenance Diso | 2021 |
Effective Treatment of Insomnia With Mirtazapine Attenuates Concomitant Suicidal Ideation.
Topics: Adult; Aged; Antidepressive Agents; Depressive Disorder; Humans; Male; Middle Aged; Mirtazapine; Sle | 2018 |
Treatment of phantom shocks: A case report.
Topics: Antidepressive Agents; Anxiety Disorders; Cocaine-Related Disorders; Defibrillators, Implantable; De | 2019 |
Real-world, open-label study to evaluate the effectiveness of mirtazapine on sleep quality in outpatients with major depressive disorder.
Topics: Adult; Antidepressive Agents; Depressive Disorder, Major; Female; Humans; Male; Mianserin; Middle Ag | 2014 |
Propafenone associated severe central nervous system and cardiovascular toxicity due to mirtazapine: a case of severe drug interaction.
Topics: Aged; Anti-Arrhythmia Agents; Antidepressive Agents, Tricyclic; Atrial Fibrillation; Bradycardia; Di | 2014 |
Neuromyotonia with polyneuropathy, prominent psychoorganic syndrome, insomnia, and suicidal behavior without antibodies: a case report.
Topics: Adrenergic alpha-Antagonists; Aged; Antidepressive Agents, Second-Generation; Electromyography; Huma | 2015 |
Case series of perimenopausal women with insomnia treated with mirtazapine followed by prolonged-release melatonin add-on and monotherapy.
Topics: Antidepressive Agents, Tricyclic; Body Weight; Delayed-Action Preparations; Dose-Response Relationsh | 2011 |
FPIN's clinical inquiries: Antidepressants for the treatment of insomnia in patients with depression.
Topics: Amitriptyline; Antidepressive Agents; Antidepressive Agents, Tricyclic; Depression; Dose-Response Re | 2011 |
Low-dose mirtazapine added to selective serotonin reuptake inhibitors in pregnant women with major depression or panic disorder including symptoms of severe nausea, insomnia and decreased appetite: three cases.
Topics: Adult; Antidepressive Agents, Tricyclic; Depression; Dose-Response Relationship, Drug; Feeding and E | 2013 |
Mirtazapine for PTSD nightmares.
Topics: Antidepressive Agents; Dreams; Humans; Mianserin; Mirtazapine; Refugees; Sleep Initiation and Mainte | 2002 |
Effect of mirtazapine versus fluoxetine on "sleep quality".
Topics: Antidepressive Agents, Tricyclic; Comorbidity; Depressive Disorder; Dose-Response Relationship, Drug | 2004 |
[Motivational therapy can fail here. Sleep disorders in depressions].
Topics: Antidepressive Agents, Tricyclic; Arousal; Citalopram; Depressive Disorder, Major; Dose-Response Rel | 2004 |
Combination pharmacotherapy for adult ADHD.
Topics: Adolescent; Adult; Antidepressive Agents, Tricyclic; Attention Deficit Disorder with Hyperactivity; | 2006 |
Anxiety and depression after lung transplantation: Mirtazapine as a first-choice agent?
Topics: Antidepressive Agents, Tricyclic; Anxiety Disorders; Depressive Disorder; Drug Interactions; Humans; | 2007 |
The management of insomnia in the older adult.
Topics: Aged; Aged, 80 and over; Anti-Anxiety Agents; Antidepressive Agents; Baths; Exercise; Humans; Hypnot | 2007 |
Effect of serotonin receptor 2A gene polymorphism on mirtazapine response in major depression.
Topics: Antidepressive Agents, Tricyclic; Asian People; Case-Control Studies; Depressive Disorder, Major; Fe | 2007 |
Clinical pharmacology of mirtazapine: revisited.
Topics: Agranulocytosis; Antidepressive Agents, Tricyclic; Anxiety; Depression; Humans; Mianserin; Mirtazapi | 1999 |
Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study.
Topics: Adolescent; Adrenergic alpha-Antagonists; Adult; Aged; Antidepressive Agents, Tricyclic; Depressive | 2000 |
Mirtazapine for treatment of depression and comorbidities in Alzheimer disease.
Topics: Aged; Aged, 80 and over; Alzheimer Disease; Antidepressive Agents, Tricyclic; Comorbidity; Depressio | 2001 |
Mirtazapine may be useful in treating nausea and insomnia of cancer chemotherapy.
Topics: Antidepressive Agents, Tricyclic; Antineoplastic Agents; Humans; Mianserin; Mirtazapine; Nausea; Sle | 2001 |