zaleplon has been researched along with Chronic Insomnia in 86 studies
zaleplon: an azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; a hypnotic with less marked effect on psychomotor functions compared to lorazepam
zaleplon : A pyrazolo[1,5-a]pyrimidine having a nitrile group at position 3 and a 3-(N-ethylacetamido)phenyl substituent at the 7-position.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To identify and analyze postmarketing cases of complex sleep behaviors (CSBs) resulting in serious injuries, including death, associated with eszopiclone, zaleplon, or zolpidem (Z-drugs)." | 9.05 | Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death. ( Chan, V; Croteau, D; Harbourt, K; Nevo, ON; Zhang, R, 2020) |
| "There is evidence that treating insomnia may improve not only sleep, but depression and metabolic function, as well." | 5.62 | Treatment of Insomnia with Zaleplon in HIV+ Significantly Improves Sleep and Depression. ( Goldschmied, JR; Kayser, MS; Morales, KH; Sengupta, A; Sharma, A; Taylor, L; Thase, ME; Weljie, A, 2021) |
| "To identify and analyze postmarketing cases of complex sleep behaviors (CSBs) resulting in serious injuries, including death, associated with eszopiclone, zaleplon, or zolpidem (Z-drugs)." | 5.05 | Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death. ( Chan, V; Croteau, D; Harbourt, K; Nevo, ON; Zhang, R, 2020) |
| "The aim of this work is to develop self-nano emulsifying drug delivery system (SNEDDS) to enhance the oral bioavailability of zaleplon (Zal) as a poorly water-soluble drug." | 2.90 | Enhancement of zaleplon oral bioavailability using optimized self-nano emulsifying drug delivery systems and its effect on sleep quality among a sample of psychiatric patients. ( Eassa, HA; Elaidy, AM; Khalifa, MKA; Salem, HA; Shawky, SM, 2019) |
| "Melatonin was measured by an ELISA assay." | 2.74 | Zaleplon increases nocturnal melatonin secretion in humans. ( Abreu-Gonzalez, P; Henry, M; Morera, AL, 2009) |
| "We assessed the preference of insomniac patients between a single dose of 10 mg zolpidem or zaleplon, respectively, administered in random order on two consecutive nights." | 2.71 | Preference of insomniac patients between a single dose of zolpidem 10 mg versus zaleplon 10 mg. ( Allain, H; Bentué-Ferrer, D; Breton, SL; Gandon, JM; Polard, E, 2003) |
| "A recent survey has shown that insomnia is still a very common problem in maintenance hemodialysis (MHD) patients." | 2.71 | Zaleplon improves sleep quality in maintenance hemodialysis patients. ( Cesaro, A; Cianciaruso, B; Crispo, A; Federico, S; Mirenghi, F; Pisani, A; Ragosta, A; Sabbatini, M, 2003) |
| "Insomnia is a common problem that increases with age and can last months to years." | 2.71 | Long-term use of sedative hypnotics in older patients with insomnia. ( Ancoli-Israel, S; Hall, P; Jenkins, L; Jones, WS; Mangano, RM; Richardson, GS, 2005) |
| "No clear evidence of rebound insomnia was noted." | 2.69 | Efficacy of L-846 in patients with insomnia: evaluation by polysomnography. ( Mizuma, H; Mukai, M; Nakazawa, Y; Sakamoto, T; Shirakawa, SI; Uchimura, N, 1998) |
| "Insomnia is a frequent complaint in the elderly population." | 2.69 | Zaleplon shortens subjective sleep latency and improves subjective sleep quality in elderly patients with insomnia. The Zaleplon Clinical Investigator Study Group. ( Emilien, G; Farr, I; Hedner, J; Salinas, E; Yaeche, R, 2000) |
| "There was no evidence of rebound insomnia or withdrawal symptoms after discontinuation of 4 weeks of zaleplon treatment." | 2.69 | Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group. ( Elie, R; Emilien, G; Farr, I; Rüther, E; Salinas, E, 1999) |
| " Other agents commonly used at sea-level such as eszopiclone and diphenhydramine have not been studied at high altitude but are likely safe to use given their mechanism of action and known side effects." | 2.44 | Which medications are safe and effective for improving sleep at high altitude? ( Luks, AM, 2008) |
| "The treatment of insomnia involves pharmacological and non-pharmacological interventions." | 2.43 | Benefit-risk assessment of zaleplon in the treatment of insomnia. ( Barbera, J; Shapiro, C, 2005) |
| "This article will review the causes of insomnia in the elderly, the approach to patient evaluation, and the nonpharmacologic and pharmacologic treatment of insomnia." | 2.43 | Insomnia in the elderly: cause, approach, and treatment. ( Gammack, JK; Kamel, NS, 2006) |
| "Insomnia has high prevalence rates and is associated with significant personal and socioeconomic burden, yet it remains largely underrecognized and inadequately treated." | 2.43 | Diagnosis and treatment of chronic insomnia: a review. ( Benca, RM, 2005) |
| "For the symptomatic drug treatment of insomnias, the specific metabolic and pharmacokinetic, as well as possible interactions, should be considered." | 2.42 | [Drug treatment of sleep disorders in the elderly]. ( Wiegand, MH, 2003) |
| " Rifampicin significantly induced the metabolism of the newer hypnosedatives and decreased their sedative effects, indicating that a dose increase of these agents may be necessary when they are administered with rifampicin." | 2.42 | Clinically important drug interactions with zopiclone, zolpidem and zaleplon. ( Greenblatt, DJ; Hesse, LM; von Moltke, LL, 2003) |
| "The impact of insomnia on daytime functioning and its relationship with medical and psychiatric illnesses necessitate early treatment to prevent insomnia becoming persistent and to avoid the development of complications." | 2.42 | New drugs for insomnia: comparative tolerability of zopiclone, zolpidem and zaleplon. ( Palomba, V; Parrino, L; Rossi, M; Smerieri, A; Terzano, MG, 2003) |
| "Rebound insomnia was not observed after sudden discontinuation of up to 12 months' treatment with zaleplon 5 and 10 mg/night and up to 4 weeks' treatment with zaleplon 20 mg/night." | 2.41 | Zaleplon: a review of its use in the treatment of insomnia. ( Dooley, M; Plosker, GL, 2000) |
| "Zaleplon has been shown to be active in a number of different anticonvulsant models, including the pentylenetetrazole, isoniazid and electroshock models." | 2.41 | Zaleplon - a review of a novel sedative hypnotic used in the treatment of insomnia. ( Heydorn, WE, 2000) |
| "Insomnia has a substantial impact on daily functioning." | 2.41 | Zaleplon: a pyrazolopyrimidine sedative-hypnotic agent for the treatment of insomnia. ( Augustin, SG; Strom, JG; Weitzel, KW; Wickman, JM, 2000) |
| "Insomnia is common among the primary care patient population, 1." | 2.41 | Implications of hypnotic flexibility on patterns of clinical use. ( Lader, MH, 2001) |
| "Many patients with insomnia describe their sleep problems as an inability to remain asleep throughout the night, resulting in next-day fatigue that may adversely affect daytime functioning." | 2.41 | Individualizing therapy for early, middle-of-the-night and late-night insomnia. ( Scharf, MB, 2001) |
| "Unresolved insomnia that impairs daytime function may be associated with significant psychiatric morbidity, predominantly major depression." | 2.41 | The relationship between psychiatric diseases and insomnia. ( Roth, T, 2001) |
| "Zaleplon is a non-benzodiazepine sleep medication that shows efficacy as a sleep inducer comparable to that of other hypnotics but with significantly fewer residual effects." | 2.41 | Efficacy and safety of zaleplon at peak plasma levels. ( Mangano, RM, 2001) |
| "Insomnia is a cardinal symptom for many psychiatric disorders, especially depressive disorders." | 2.41 | A psychiatric perspective on insomnia. ( McCall, WV, 2001) |
| "In particular, patients with chronic insomnia have higher rates of psychiatric and medical illnesses, and insomnia is an important risk factor in the development of depression." | 2.41 | Consequences of insomnia and its therapies. ( Benca, RM, 2001) |
| "Insomnia is the most frequently reported sleep symptom, severely affecting up to 15% of the US population." | 2.41 | Management of insomnia--the role of zaleplon. ( Kramer, JA; Richardson, GS; Roth, T, 2002) |
| "Transient and chronic insomnia are common problems that should be clinically evaluated and appropriately treated." | 2.41 | Safety of zaleplon in the treatment of insomnia. ( Israel, AG; Kramer, JA, 2002) |
| "Key search terms included insomnia, benzodiazepines, zolpidem, zopiclone, zaleplon, Cl 284,846, melatonin, and valerian." | 2.40 | Beyond benzodiazepines: alternative pharmacologic agents for the treatment of insomnia. ( Hening, WA; Wagner, J; Wagner, ML, 1998) |
| "There is evidence that treating insomnia may improve not only sleep, but depression and metabolic function, as well." | 1.62 | Treatment of Insomnia with Zaleplon in HIV+ Significantly Improves Sleep and Depression. ( Goldschmied, JR; Kayser, MS; Morales, KH; Sengupta, A; Sharma, A; Taylor, L; Thase, ME; Weljie, A, 2021) |
| "Zaleplon (ZLP) was used as a model drug intended to induce sleep and to treat middle of night insomnia." | 1.48 | Zaleplon loaded bi-layered chronopatch: A novel buccal chronodelivery approach to overcome circadian rhythm related sleep disorder. ( Abd El Malak, NS; Farag, MM; Yehia, SA, 2018) |
| "For the treatment of insomnia in older adults, eszopiclone may present a safer alternative to zolpidem, in terms of fall-related injuries." | 1.43 | Nonbenzodiazepine Sedative Hypnotics and Risk of Fall-Related Injury. ( Albrecht, JS; Park, Y; Tom, SE; Wickwire, EM, 2016) |
| " A NEG composed of 15% Miglyol, 30% Labrasol and 10% PEG 200 successfully provided the maximum in vitro and ex vivo permeation and enhanced the bioavailability in the rabbits by eightfold, when compared with the marketed tablets." | 1.39 | The formulation of a nasal nanoemulsion zaleplon in situ gel for the treatment of insomnia. ( Banjar, ZM; Hosny, KM, 2013) |
| " The mean half-life in healthy nonelderly individuals (6." | 1.38 | Pharmacokinetic evaluation of eszopiclone: clinical and therapeutic implications. ( Greenblatt, DJ; Zammit, GK, 2012) |
| "Although it has been claimed that insomnia causes an increased risk for depression, adequate controlled trials testing this hypothesis have not been available." | 1.34 | Greater incidence of depression with hypnotic use than with placebo. ( Kripke, DF, 2007) |
| "One of the most common treatments for insomnia is prescription sleep medications that help people fall asleep and remain asleep." | 1.34 | What every dentist should know about the "z-sedatives". ( McKenzie, WS; Rosenberg, M, 2007) |
| "Insomnia is a highly prevalent sleep problem that often results in poor daily functioning of the affected patient." | 1.31 | Treatment of insomnia with zaleplon, a novel sleep medication. ( Doghramji, PP, 2001) |
| "Zaleplon (Sonata) is an original hypnotic derived from the pyrazolopyrimidine with a full agonistic activity on central benzodiazepine receptors B21 type." | 1.30 | [Pharma-clinics. Drug of the month. Zaleplon (Sonata)]. ( Ansseau, M, 1999) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 7 (8.14) | 18.2507 |
| 2000's | 58 (67.44) | 29.6817 |
| 2010's | 18 (20.93) | 24.3611 |
| 2020's | 3 (3.49) | 2.80 |
| Authors | Studies |
|---|---|
| Khalifa, MKA | 1 |
| Salem, HA | 1 |
| Shawky, SM | 1 |
| Eassa, HA | 1 |
| Elaidy, AM | 1 |
| Harbourt, K | 1 |
| Nevo, ON | 1 |
| Zhang, R | 1 |
| Chan, V | 1 |
| Croteau, D | 1 |
| Citrome, L | 1 |
| Juday, T | 1 |
| Frech, F | 1 |
| Atkins, N | 1 |
| Goldschmied, JR | 1 |
| Sengupta, A | 1 |
| Sharma, A | 1 |
| Taylor, L | 1 |
| Morales, KH | 1 |
| Thase, ME | 2 |
| Weljie, A | 1 |
| Kayser, MS | 1 |
| Treves, N | 1 |
| Perlman, A | 1 |
| Kolenberg Geron, L | 1 |
| Asaly, A | 1 |
| Matok, I | 1 |
| Farag, MM | 1 |
| Abd El Malak, NS | 1 |
| Yehia, SA | 1 |
| Kong, F | 1 |
| Liu, G | 1 |
| Xu, J | 1 |
| Aschenbrenner, DS | 1 |
| Hosny, KM | 1 |
| Banjar, ZM | 1 |
| Baier, PC | 1 |
| Kapil, V | 1 |
| Green, JL | 1 |
| Le Lait, C | 1 |
| Wood, DM | 1 |
| Dargan, PI | 1 |
| Zhang, YZ | 1 |
| He, HY | 1 |
| She, CM | 1 |
| Lian, J | 1 |
| Tom, SE | 1 |
| Wickwire, EM | 1 |
| Park, Y | 1 |
| Albrecht, JS | 1 |
| Luks, AM | 1 |
| Friedman, GD | 1 |
| Kripke, DF | 2 |
| Paparrigopoulos, T | 1 |
| Tzavellas, E | 1 |
| Karaiskos, D | 1 |
| Liappas, I | 1 |
| Morera, AL | 1 |
| Abreu-Gonzalez, P | 1 |
| Henry, M | 1 |
| Mets, MA | 1 |
| Volkerts, ER | 1 |
| Olivier, B | 1 |
| Verster, JC | 1 |
| Schaffer, CB | 1 |
| Schaffer, LC | 1 |
| Miller, AR | 1 |
| Hang, E | 1 |
| Nordahl, TE | 1 |
| Morgan, K | 1 |
| Kucharczyk, E | 1 |
| Gregory, P | 1 |
| Tonon, MA | 1 |
| Bonato, PS | 1 |
| Lancaster, AR | 1 |
| Lee, JA | 1 |
| Hovda, LR | 1 |
| Hardy, BT | 1 |
| Miyahara, LX | 1 |
| Martin, EP | 1 |
| Whelan, MF | 1 |
| Greenblatt, DJ | 2 |
| Zammit, GK | 1 |
| Huedo-Medina, TB | 1 |
| Kirsch, I | 1 |
| Middlemass, J | 1 |
| Klonizakis, M | 1 |
| Siriwardena, AN | 2 |
| Montplaisir, J | 1 |
| Hawa, R | 1 |
| Moller, H | 1 |
| Morin, C | 1 |
| Fortin, M | 1 |
| Matte, J | 1 |
| Reinish, L | 1 |
| Shapiro, CM | 2 |
| Terzano, MG | 1 |
| Rossi, M | 1 |
| Palomba, V | 1 |
| Smerieri, A | 1 |
| Parrino, L | 1 |
| Hesse, LM | 1 |
| von Moltke, LL | 1 |
| Allain, H | 2 |
| Bentué-Ferrer, D | 2 |
| Breton, SL | 1 |
| Polard, E | 2 |
| Gandon, JM | 1 |
| Sabbatini, M | 1 |
| Crispo, A | 1 |
| Pisani, A | 1 |
| Ragosta, A | 1 |
| Cesaro, A | 1 |
| Mirenghi, F | 1 |
| Cianciaruso, B | 1 |
| Federico, S | 1 |
| Wiegand, MH | 1 |
| Noguchi, H | 1 |
| Kitazumi, K | 1 |
| Mori, M | 1 |
| Shiba, T | 1 |
| Dündar, Y | 1 |
| Dodd, S | 1 |
| Strobl, J | 1 |
| Boland, A | 1 |
| Dickson, R | 1 |
| Walley, T | 1 |
| Liskow, B | 1 |
| Pikalov, A | 1 |
| Sanger, DJ | 1 |
| Schwartz, T | 1 |
| Nihalani, N | 1 |
| Virk, S | 1 |
| Jindal, S | 1 |
| Costello, A | 1 |
| Muldoon, R | 1 |
| Azhar, N | 1 |
| Hussein, J | 1 |
| Tirmazi, S | 1 |
| Ancoli-Israel, S | 1 |
| Richardson, GS | 2 |
| Mangano, RM | 2 |
| Jenkins, L | 1 |
| Hall, P | 1 |
| Jones, WS | 1 |
| Nutt, DJ | 1 |
| Alford, C | 1 |
| Verster, J | 1 |
| Anderson, I | 1 |
| Baldwin, D | 1 |
| Lader, M | 1 |
| Benca, RM | 2 |
| Barbera, J | 1 |
| Shapiro, C | 1 |
| Akwa, Y | 1 |
| Patat, A | 2 |
| Neubauer, D | 1 |
| Kamel, NS | 1 |
| Gammack, JK | 1 |
| Antai-Otong, D | 1 |
| Capua, T | 1 |
| Cranwell-Bruce, LA | 1 |
| Stone, JR | 1 |
| Zorick, TS | 1 |
| Tsuang, J | 1 |
| McKenzie, WS | 1 |
| Rosenberg, M | 1 |
| Belleville, G | 1 |
| Morin, CM | 1 |
| Qureshi, MZ | 1 |
| Dyas, JV | 1 |
| Middleton, H | 1 |
| Orner, R | 1 |
| Sakamoto, T | 1 |
| Uchimura, N | 1 |
| Mukai, M | 1 |
| Mizuma, H | 1 |
| Shirakawa, SI | 1 |
| Nakazawa, Y | 1 |
| Wagner, J | 1 |
| Wagner, ML | 1 |
| Hening, WA | 1 |
| Elie, R | 1 |
| Rüther, E | 1 |
| Farr, I | 2 |
| Emilien, G | 2 |
| Salinas, E | 2 |
| Henney, JE | 1 |
| Scharf, M | 2 |
| Ansseau, M | 1 |
| Fry, J | 1 |
| Mangano, R | 1 |
| Fujimori, M | 1 |
| Hedner, J | 1 |
| Yaeche, R | 1 |
| Dooley, M | 1 |
| Plosker, GL | 1 |
| Heydorn, WE | 1 |
| Weitzel, KW | 1 |
| Wickman, JM | 1 |
| Augustin, SG | 1 |
| Strom, JG | 1 |
| Bhatia, SC | 1 |
| Arora, M | 1 |
| Bhatia, SK | 1 |
| Lader, MH | 1 |
| Scharf, MB | 1 |
| Roth, T | 2 |
| McCall, WV | 1 |
| Doghramji, PP | 1 |
| George, CF | 1 |
| Stone, BM | 1 |
| Turner, C | 1 |
| Mills, SL | 1 |
| Paty, I | 1 |
| Darwish, M | 1 |
| Danjou, P | 1 |
| Kramer, JA | 2 |
| Israel, AG | 1 |
| Schreiber, V | 1 |
| Finucane, TE | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)[NCT02783729] | Phase 3 | 1,006 participants (Actual) | Interventional | 2016-05-31 | Completed | ||
| A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)[NCT02952820] | Phase 3 | 971 participants (Actual) | Interventional | 2016-11-15 | Completed | ||
| A 6-week Open-Label Study of Treatment of Insomnia With Zaleplon in HIV Positive Patients With Comorbid Depression[NCT03489304] | Phase 2 | 20 participants (Actual) | Interventional | 2014-04-03 | Completed | ||
| Treatment of High-altitude Sleep Disturbance: A Double-blind Comparison of Temazepam Versus Acetazolamide.[NCT01519544] | 34 participants (Actual) | Interventional | 2012-03-31 | Completed | |||
| Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder[NCT05257317] | 50 participants (Anticipated) | Interventional | 2022-02-28 | Recruiting | |||
| Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers[NCT04632628] | 60 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting | |||
| Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home Prospective, Monocentric and Open Study[NCT03594851] | 45 participants (Actual) | Interventional | 2018-01-08 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"The FSS is a self-report scale on which participants are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each of 9 statements about their fatigue where 1 indicates strongly disagree, and 7 indicates strongly agree. The FSS total score was the sum of all responses to the 9 questions. The FSS average item score was the average of the score for each item. Higher total scores and higher average item scores indicated greater fatigue." (NCT02783729)
Timeframe: Baseline and Day 31
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change at Day 31 | |
| Lemborexant 10 mg | 37.42 | -8.00 |
| Lemborexant 5 mg | 37.47 | -8.14 |
| Placebo | 37.48 | -6.75 |
| Zolpidem Tartrate Extended Release 6.25 mg | 37.15 | -7.80 |
Body sway is detected through a cable around the participant's waist by the ataxia meter. Body sway is measured in units of one-third degree of the angle of arc. For ease in reporting, these are called arbitrary units, with a higher number indicating more body sway (less postural stability). Change from baseline in mean body sway on Days 2 and 3 was reported. (NCT02783729)
Timeframe: Baseline, Days 2/3
| Intervention | one-third degree of angle of arc (Mean) | |
|---|---|---|
| Baseline | Change at Days 2/3 | |
| Lemborexant 10 mg | 36.29 | -8.97 |
| Lemborexant 5 mg | 26.40 | -0.82 |
| Zolpidem Tartrate Extended Release 6.25 mg | 26.96 | 8.47 |
LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported. (NCT02783729)
Timeframe: Baseline, Days 29/30
| Intervention | minutes (Mean) | |
|---|---|---|
| Baseline | Change at Days 29/30 | |
| Lemborexant 10 mg | 44.61 | -21.46 |
| Lemborexant 5 mg | 44.86 | -19.53 |
| Placebo | 43.89 | -7.93 |
LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by the PSG. WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. TST is defined as the amount of sleep in minutes from LPS until terminal awakening as measured by PSG. Change from baseline to average LPS, WASO, and TST on Days 1 and 2, and Days 29 and 30 were reported. (NCT02783729)
Timeframe: Baseline, Days 1/2, and Days 29/30
| Intervention | minutes (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| LPS: Baseline | LPS: Change at Days 1/2 | LPS: Change at Days 29/30 | WASO: Baseline | WASO: Change at Days 1/2 | WASO: Change at Days 29/30 | TST: Baseline | TST: Change at Days 1/2 | TST: Change at Days 29/30 | |
| Lemborexant 10 mg | 44.61 | -19.48 | -21.46 | 114.83 | -59.59 | -46.43 | 325.07 | 79.58 | 67.86 |
| Lemborexant 5 mg | 44.86 | -16.59 | -19.53 | 113.44 | -49.96 | -43.89 | 328.00 | 65.22 | 61.99 |
| Zolpidem Tartrate Extended Release 6.25 mg | 44.52 | -12.56 | -7.51 | 114.31 | -44.36 | -36.50 | 326.99 | 55.31 | 43.34 |
LPS: amount of time in minutes from lights off to first epoch of 20 consecutive epochs of non-wakefulness. WASO: amount of time in minutes of wake from the onset of persistent sleep until lights. WASO2H: amount of time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST: amount of time in minutes of sleep from sleep onset until terminal awakening. LPS, WASO, WASO2H, and TST were measured by PSG. Change from baseline to average LPS, WASO, WASO2H, and TST on Day 1 and 2 were reported. (NCT02783729)
Timeframe: Baseline, Days 1/2
| Intervention | minutes (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| LPS: Baseline | LPS: Change at Days 1/2 | WASO: Baseline | WASO: Change at Days 1/2 | WASO2H: Baseline | WASO2H: Change at Days 1/2 | TST: Baseline | TST: Change at Days 1/2 | |
| Lemborexant 10 mg | 44.61 | -19.48 | 114.83 | -59.59 | 76.88 | -37.10 | 325.07 | 79.58 |
| Lemborexant 5 mg | 44.86 | -16.59 | 113.44 | -49.96 | 76.60 | -30.28 | 328.00 | 65.22 |
| Placebo | 43.89 | -6.45 | 111.75 | -15.07 | 74.44 | -7.06 | 330.67 | 19.44 |
POA reflects the ability to focus attention and process information. POA is calculated from the sum of simple reaction time, choice reaction time and digit vigilance. SOMT reflects time taken to retrieve information from working and episodic memory. SOMT is a composite score created by combining numerical working memory and spatial working memory and word recognition and picture recognition. Cognitive performance assessment was done by a computerized performance assessment battery (PAB) which was administered on a laptop computer. A positive change from baseline reflects impairment and a lower value of decrease from baseline indicates better performance. Change from baseline to average POA and SOMT on Days 2 and 3 was reported. (NCT02783729)
Timeframe: Baseline, Days 2/3
| Intervention | millisecond (Mean) | |||
|---|---|---|---|---|
| POA: Baseine | POA : Days 2/3 | SOMT: Baseline | SOMT: Days 2/3 | |
| Lemborexant 10 mg | 1399.2 | 31.1 | 4619.8 | -152.8 |
| Lemborexant 5 mg | 1452.9 | 8.9 | 4674.3 | -185.1 |
| Placebo | 1421.0 | -14.2 | 4507.7 | -177.9 |
| Zolpidem Tartrate Extended Release 6.25 mg | 1418.7 | 37.1 | 4513.8 | 60.7 |
QOM represents the ability to store information in memory and subsequently retrieve it. It is a composite score created by combining accuracy measures from 2 sets of working memory and 4 sets of episodic memory. Two sets of working memory were included: numerical and spatial working memory, and ranges from -2 to 2. Four sets of episodic memory were included: immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. COA is the ability to sustain attention. Number of correct responses (out of 50) for choice reaction time was added to total number of targets correctly identified (out of 45) digit vigilance minus number of false alarms (total score of -45 to 95). Higher values were better. Change from baseline to average QOM and COA on Days 2 and 3 was reported. (NCT02783729)
Timeframe: Baseline, Days 2/3
| Intervention | units on scale (Mean) | |||
|---|---|---|---|---|
| QOM: Baseline | QOM: Change at Days 2/3 | COA: Baseline | COA: Change at Days2/3 | |
| Lemborexant 10 mg | 340.7 | -2.8 | 91.3 | -0.7 |
| Lemborexant 5 mg | 345.7 | 1.4 | 91.0 | 0.2 |
| Placebo | 342.2 | 3.5 | 90.7 | 0.0 |
| Zolpidem Tartrate Extended Release 6.25 mg | 350.0 | -12.1 | 90.6 | -1.0 |
SE is defined as percentage of time spent in bed asleep, calculated as TST divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 1 and 2 were reported. (NCT02783729)
Timeframe: Baseline, Days 1/2
| Intervention | Percentage of time in bed asleep (Mean) | |
|---|---|---|
| SE: Baseline | SE: Change at Days 1/2 | |
| Lemborexant 10 mg | 67.85 | 16.48 |
| Lemborexant 5 mg | 68.36 | 13.60 |
| Placebo | 68.89 | 4.22 |
SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported. (NCT02783729)
Timeframe: Baseline, Days 29/30
| Intervention | Percentage of time in bed asleep (Mean) | |
|---|---|---|
| Baseline | Change at Days 29/30 | |
| Lemborexant 10 mg | 67.85 | 14.09 |
| Lemborexant 5 mg | 68.36 | 12.93 |
| Placebo | 68.89 | 5.35 |
sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. (NCT02783729)
Timeframe: First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)
| Intervention | % of subjective time in bed asleep (Mean) | ||
|---|---|---|---|
| sSE: Baseline: With DHR | sSE: Change at 1st 7 nights: With DHR | sSE: Change at last 7 nights: With DHR | |
| Lemborexant 10 mg | 54.31 | 13.97 | 16.12 |
| Lemborexant 5 mg | 56.05 | 10.56 | 12.92 |
| Placebo | 56.08 | 6.73 | 8.35 |
sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. (NCT02783729)
Timeframe: First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)
| Intervention | minutes (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| sSOL: Baseline: With DHR | sSOL: Change at 1st 7 nights :With DHR | sSOL: Change at last 7 nights: With DHR | sWASO: Baseline: With DHR | sWASO: Change at 1st 7 nights: With DHR | sWASO: Change at last 7 nights: With DHR | sTST: Baseline: With DHR | sTST: Change at 1st 7 nights: With DHR | sTST: Change at last 7 nights: With DHR | |
| Lemborexant 10 mg | 60.88 | -21.88 | -24.79 | 175.35 | -55.06 | -57.96 | 266.10 | 67.80 | 79.95 |
| Lemborexant 5 mg | 65.79 | -22.54 | -25.20 | 166.76 | -39.33 | -44.51 | 275.74 | 50.30 | 62.41 |
| Placebo | 55.90 | -6.83 | -8.10 | 170.89 | -27.92 | -36.01 | 276.23 | 30.86 | 38.98 |
WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. (NCT02783729)
Timeframe: Baseline, Days 29/30
| Intervention | minutes (Mean) | |
|---|---|---|
| Baseline | Change at Days 29/30 | |
| Lemborexant 10 mg | 114.83 | -46.43 |
| Lemborexant 5 mg | 113.44 | -43.89 |
| Placebo | 111.75 | -18.58 |
WASO2H is defined as the time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST is defined as the amount of sleep in minutes from sleep onset until terminal awakening. WASO and TST were measured by PSG. Change from baseline to average WASO and TST on Day 29 and 30 were reported. (NCT02783729)
Timeframe: Baseline, Days 29/30
| Intervention | minutes (Mean) | |||
|---|---|---|---|---|
| WASO2H: Baseline | WASO2H: Days 29 /30 | TST: Baseline | TST: Days 29/30 | |
| Lemborexant 10 mg | 76.88 | -28.84 | 325.07 | 67.86 |
| Lemborexant 5 mg | 76.60 | -27.19 | 328.00 | 61.99 |
| Placebo | 74.44 | -8.92 | 330.67 | 25.65 |
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: severity of sleep onset; sleep maintenance; early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0 = no problem to 4 = very severe problem) yielding a total score from 0 to 28. (NCT02783729)
Timeframe: Baseline and Day 31
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change at Day 31 | |
| Lemborexant 10 mg | 10.84 | -4.77 |
| Lemborexant 5 mg | 10.91 | -4.83 |
| Placebo | 11.21 | -3.88 |
| Zolpidem Tartrate Extended Release 6.25 mg | 11.06 | -5.24 |
sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. (NCT02783729)
Timeframe: First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)
| Intervention | % of subjective time in bed asleep (Mean) | ||
|---|---|---|---|
| sSE: Baseline: With DHR | sSE: Change at 1st 7 nights: With DHR | sSE: Change at last 7 nights: With DHR | |
| Lemborexant 10 mg | 54.31 | 13.97 | 16.12 |
| Lemborexant 5 mg | 56.05 | 10.56 | 12.92 |
| Zolpidem Tartrate Extended Release 6.25 mg | 55.49 | 11.96 | 14.83 |
sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with diary handling rules (DHR) on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. (NCT02783729)
Timeframe: First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)
| Intervention | minutes (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| sSOL: Baseline: With DHR | sSOL: 1st 7 nights: With DHR | sSOL: last 7 nights: With DHR | sWASO: Baseline: With DHR | sWASO: Change at 1st 7 nights: With DHR | sWASO: Change at last 7 nights: With DHR | sTST: Baseline: With DHR | sTST: Change at 1st 7 nights: With DHR | sTST: Change at last 7 nights: With DHR | |
| Lemborexant 10 mg | 60.88 | -21.88 | -24.79 | 175.35 | -55.06 | -57.96 | 266.10 | 67.80 | 79.95 |
| Lemborexant 5 mg | 65.79 | -22.54 | -25.20 | 166.76 | -39.33 | -44.51 | 275.74 | 50.30 | 62.41 |
| Zolpidem Tartrate Extended Release 6.25 mg | 60.54 | -16.23 | -17.04 | 173.06 | -48.91 | -63.52 | 273.07 | 56.99 | 71.01 |
WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported. (NCT02783729)
Timeframe: Baseline, Days 29/30
| Intervention | minutes (Mean) | |
|---|---|---|
| Baseline | Change at Days 29/30 | |
| Lemborexant 10 mg | 76.88 | -28.84 |
| Lemborexant 5 mg | 76.60 | -27.19 |
| Zolpidem Tartrate Extended Release 6.25 mg | 78.04 | -21.42 |
Objective sleep onset response: LPS less than or equal to (<=) 20 minutes (mins) provided baseline LPS was greater than (>) 30 mins. Subjective sleep onset response: sSOL <=20 mins provided mean baseline sSOL was >30 mins. Objective sleep maintenance response: WASO <=60 minutes provided baseline WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective sleep maintenance response: sWASO <=60 mins provided mean WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. Average data for Days 1 and 2, Days 29 and 30, and first and last 7 nights of treatment period was reported. (NCT02783729)
Timeframe: Days 1/2, Days 29/30, first 7 night (approximately Week 1), and Last seven nights (approximately Week 4)
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| LPS: Days 1/2 | LPS: Days 29/30 | sSOL: First 7 nights (with DHR) | sSOL: Last 7 nights (with DHR) | WASO: Days 1/2 | WASO: Days 29/30 | sWASO: First 7 nights (with DHR) | sWASO: Last 7 nights (with DHR) | |
| Lemborexant 10 mg | 17.8 | 22.3 | 10.4 | 14.5 | 64.3 | 46.1 | 20.4 | 23.0 |
| Lemborexant 5 mg | 15.8 | 20.3 | 9.8 | 16.9 | 51.1 | 44.4 | 16.9 | 23.3 |
| Placebo | 15.4 | 15.9 | 2.9 | 7.2 | 16.8 | 22.1 | 9.6 | 15.4 |
| Zolpidem Tartrate Extended Release 6.25 mg | 10.3 | 11.4 | 7.6 | 8.7 | 46.0 | 34.6 | 16.7 | 23.2 |
"The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where 1 indicates strongly disagree and 7, strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63." (NCT02952820)
Timeframe: Baseline, Months 1, 3 and 6
| Intervention | score on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 36.0 | -6.4 | -7.9 | -8.9 |
| Lemborexant 5 mg | 37.4 | -6.6 | -7.7 | -10.1 |
| Placebo | 35.2 | -3.9 | -4.3 | -6.3 |
The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16. (NCT02952820)
Timeframe: Baseline, Months 1, 3, and 6
| Intervention | score on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 11.0 | -4.2 | -5.2 | -5.7 |
| Lemborexant 5 mg | 11.4 | -4.1 | -5.2 | -6.0 |
| Placebo | 11.0 | -3.1 | -3.7 | -4.3 |
"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome." (NCT02952820)
Timeframe: Baseline, Months 1, 3, 6, 9 and 12
| Intervention | score on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change at Month 1 of exposure | Change at Month 3 of exposure | Change at Month 6 of exposure | Change at Month 9 of exposure | Change at Month 12 of exposure | |
| Lemborexant 10 mg | 4.16 | 0.42 | 0.70 | 0.86 | 1.08 | 1.31 |
| Lemborexant 5 mg | 4.15 | 0.46 | 0.60 | 0.78 | 1.00 | 1.11 |
(NCT02952820)
Timeframe: Baseline, First 7 nights (approximately Week 1) in active treatment period
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Baseline | Change at First 7 nights | |
| Lemborexant 10 mg | 4.16 | 0.33 |
| Lemborexant 5 mg | 4.15 | 0.36 |
"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome." (NCT02952820)
Timeframe: Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Change at First 7 nights | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 3.93 | 0.33 | 0.55 | 0.90 | 1.05 |
| Lemborexant 5 mg | 3.93 | 0.36 | 0.53 | 0.74 | 0.98 |
| Placebo | 3.94 | 0.15 | 0.44 | 0.62 | 0.79 |
sSOL was defined as estimated minutes from time attempted to sleep to sleep onset. (NCT02952820)
Timeframe: Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3
| Intervention | minutes (Mean) | |||
|---|---|---|---|---|
| Baseline | Change at 1st 7 nights | Change at Month 1 | Change at Month 3 | |
| Lemborexant 10 mg | 64.97 | -18.89 | -24.06 | -27.94 |
| Lemborexant 5 mg | 62.19 | -16.86 | -19.41 | -25.08 |
| Placebo | 64.03 | -4.11 | -11.48 | -13.84 |
sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night. (NCT02952820)
Timeframe: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
| Intervention | minutes (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Change at first 7 nights | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 306.89 | 46.01 | 53.22 | 70.95 | 78.32 |
| Lemborexant 5 mg | 315.52 | 34.29 | 39.32 | 65.82 | 76.21 |
| Placebo | 304.25 | 14.78 | 30.74 | 48.16 | 53.53 |
sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. (NCT02952820)
Timeframe: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
| Intervention | percentage of sTST (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Change at 1st 7 nights | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 62.03 | 8.27 | 9.92 | 13.61 | 15.55 |
| Lemborexant 5 mg | 63.14 | 6.61 | 7.87 | 13.03 | 15.34 |
| Placebo | 61.34 | 2.68 | 6.11 | 9.16 | 10.36 |
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. (NCT02952820)
Timeframe: Baseline and Month 6
| Intervention | minutes (Mean) | |
|---|---|---|
| Baseline | Change at Month 6 | |
| Lemborexant 10 mg | 64.97 | -32.49 |
| Lemborexant 5 mg | 62.19 | -29.39 |
| Placebo | 64.03 | -16.57 |
sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. (NCT02952820)
Timeframe: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
| Intervention | minutes (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Change at first 7 nights | Change at Month 1 | Change at Month 3 | Change at Month 6 | |
| Lemborexant 10 mg | 136.83 | -23.30 | -26.82 | -39.42 | -48.12 |
| Lemborexant 5 mg | 132.77 | -20.21 | -23.42 | -42.98 | -51.45 |
| Placebo | 132.49 | -6.12 | -19.01 | -27.08 | -32.14 |
"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome." (NCT02952820)
Timeframe: Screening, First and second 7 mornings in follow-up period (Week 52 to 54)
| Intervention | score on a scale (Mean) | ||
|---|---|---|---|
| Screening | Change at First 7 mornings | Change at Second 7 mornings | |
| Lemborexant 10 mg | 3.54 | 1.32 | 1.22 |
| Lemborexant 5 mg | 3.63 | 1.03 | 0.98 |
Sleep onset responder was defined as follows: sSOL at study Baseline was >=30 minutes and mean sSOL at 6 months was <=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of > 10 minutes compared to study Baseline. (NCT02952820)
Timeframe: Month 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Sleep Onset Responders | Sleep Maintainance Responders | |
| Lemborexant 10 mg | 37.2 | 39.6 |
| Lemborexant 5 mg | 34.2 | 35.0 |
Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (>=) 30 minutes and mean sSOL at 6 months was less than or equal to (<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of greater than (>)10 minutes compared to Study Baseline. (NCT02952820)
Timeframe: Month 6
| Intervention | percentage of responders (Number) | |
|---|---|---|
| Sleep Onset Responders | Sleep Maintenance Responders | |
| Lemborexant 10 mg | 30.1 | 30.0 |
| Lemborexant 5 mg | 31.2 | 35.0 |
| Placebo | 17.7 | 20.4 |
sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE. (NCT02952820)
Timeframe: Baseline, Months 1, 3, 6, 9, and 12
| Intervention | percentage of sTST (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Change at Month 1 of exposure | Change at Month 3 of exposure | Change at Month 6 of exposure | Change at Month 9 of exposure | Change at Month 12 of exposure | |
| Lemborexant 10 mg | 7.32 | 10.25 | 11.08 | 12.84 | 13.66 |
| Lemborexant 5 mg | 6.35 | 10.01 | 11.10 | 11.85 | 12.61 |
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO. (NCT02952820)
Timeframe: Baseline, Month 1, 3, 6, 9, 12
| Intervention | minutes (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| sSOL: Change at Month 1 of exposure | sSOL: Change at Month 3 of exposure | sSOL: Change at Month 6 of exposure | sSOL: Change at Month 9 of exposure | sSOL: Change at Month 12 of exposure | sWASO: Change at Month 1 of exposure | sWASO: Change at Month 3 of exposure | sWASO: Change at Month 6 of exposure | sWASO: Change at Month 9 of exposure | sWASO: Change at Month 12 of exposure | sTST: Change at Month 1 of exposure | sTST: Change at Month 3 of exposure | sTST: Change at Month 6 of exposure | sTST: Change at Month 9 of exposure | sTST: Change at Month 12 of exposure | |
| Lemborexant 10 mg | -18.64 | -21.58 | -22.99 | -27.36 | -26.32 | -18.69 | -28.97 | -31.54 | -40.39 | -43.76 | 38.04 | 53.51 | 56.36 | 61.13 | 66.50 |
| Lemborexant 5 mg | -17.17 | -21.47 | -24.13 | -26.00 | -25.83 | -17.26 | -31.34 | -36.10 | -39.28 | -42.87 | 31.98 | 49.27 | 54.99 | 55.41 | 58.15 |
sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE. (NCT02952820)
Timeframe: Baseline, Month 7, 9, 12
| Intervention | percentage of sTST (Least Squares Mean) | ||
|---|---|---|---|
| Change at Month 7 of exposure | Change at Month 9 of exposure | Change at Month 12 of exposure | |
| Lemborexant 10 mg | 15.12 | 16.49 | 16.82 |
| Lemborexant 5 mg | 12.88 | 16.54 | 16.34 |
sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO. (NCT02952820)
Timeframe: Baseline, Month 7, 9, 12
| Intervention | minutes (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| sSOL: Change at Month 7 of exposure | sSOL: Change at Month 9 of exposure | sSOL: Change at Month 12 of exposure | sWASO: Change at Month 7 of exposure | sWASO: Change at Month 9 of exposure | sWASO: Change at Month 12 of exposure | sTST: Change at Month 7 of exposure | sTST: Change at Month 9 of exposure | sTST: Change at Month 12 of exposure | |
| Lemborexant 10 mg | -29.46 | -30.91 | -31.33 | -43.09 | -48.87 | -49.28 | 76.95 | 81.24 | 83.61 |
| Lemborexant 5 mg | -28.55 | -32.10 | -31.40 | -45.62 | -47.70 | -48.46 | 75.00 | 78.69 | 78.61 |
sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE. (NCT02952820)
Timeframe: Baseline, Month 1, 3, 6
| Intervention | percentage of sTST (Least Squares Mean) | ||
|---|---|---|---|
| Change at Month 1 of exposure | Change at Month 3 of exposure | Change at Month 6 of exposure | |
| Lemborexant 10 mg | 7.32 | 10.25 | 11.08 |
| Lemborexant 5 mg | 6.35 | 10.01 | 11.10 |
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO. (NCT02952820)
Timeframe: Baseline, Month 1, 3, 6
| Intervention | minutes (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| sSOL: Change at Month 1 of exposure | sSOL: Change at Month 3 of exposure | sSOL: Change at Month 6 of exposure | sWASO: Change at Month 1 of exposure | sWASO: Change at Month 3 of exposure | sWASO: Change at Month 6 of exposure | sTST: Change at Month 1 of exposure | sTST: Change at Month 3 of exposure | sTST: Change at Month 6 of exposure | |
| Lemborexant 10 mg | -18.64 | -21.58 | -22.99 | -18.69 | -28.97 | -31.54 | 38.04 | 53.51 | 56.36 |
| Lemborexant 5 mg | -17.17 | -21.47 | -24.13 | -17.26 | -31.34 | -36.10 | 31.98 | 49.27 | 54.99 |
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. (NCT02952820)
Timeframe: First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)
| Intervention | minutes (Mean) | ||
|---|---|---|---|
| Mean of first 3 nights | Mean sSOL of the first 7 nights | Mean sSOL of the second 7 nights | |
| Lemborexant 10 mg | 41.73 | 41.90 | 41.30 |
| Lemborexant 5 mg | 40.35 | 41.35 | 44.10 |
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. (NCT02952820)
Timeframe: First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
| Intervention | minutes (Mean) | ||
|---|---|---|---|
| Mean of first 3 nights | Mean of the first 7 nights | Mean of the Last 7 nights | |
| Lemborexant 10 mg | 97.88 | 95.79 | 98.19 |
| Lemborexant 5 mg | 86.66 | 91.56 | 92.62 |
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. (NCT02952820)
Timeframe: First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Average of first 3 nights | Average of first 7 nights | Average of second 7 nights | |
| Lemborexant 10 mg | 9.38 | 10.53 | 9.38 |
| Lemborexant 5 mg | 9.46 | 11.94 | 11.71 |
Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. (NCT02952820)
Timeframe: First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Average of first 3 nights | Average of first 7 nights | Average of second 7 nights | |
| Lemborexant 10 mg | 12.59 | 14.19 | 11.90 |
| Lemborexant 5 mg | 11.26 | 12.39 | 13.51 |
The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness. (NCT03489304)
Timeframe: Measure at 6 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Zaleplon | 6.5 |
The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia. (NCT03489304)
Timeframe: Measure at 6 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Zaleplon | 11 |
The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms. (NCT03489304)
Timeframe: Measure at 6 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Zaleplon | 8.7 |
33 reviews available for zaleplon and Chronic Insomnia
| Article | Year |
|---|---|
Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death.
Topics: Acetamides; Adult; Adverse Drug Reaction Reporting Systems; Aged; Drug Labeling; Eszopiclone; Female | 2020 |
Z-drugs and risk for falls and fractures in older adults-a systematic review and meta-analysis.
Topics: Accidental Falls; Acetamides; Adult; Age Factors; Aged; Aged, 80 and over; Aging; Azabicyclo Compoun | 2018 |
Pharmacological agents for improving sleep quality at high altitude: a systematic review and meta-analysis of randomized controlled trials.
Topics: Acetamides; Acetazolamide; Adult; Altitude; Anticonvulsants; Humans; Hypnotics and Sedatives; Pyrimi | 2018 |
Drugs for Insomnia.
Topics: Acetamides; Animals; Eszopiclone; Humans; Hypnotics and Sedatives; Plant Preparations; Pyridines; Py | 2015 |
[Research Progress on Forensic Toxicology of Z-drugs].
Topics: Acetamides; Azabicyclo Compounds; Drug Overdose; Forensic Medicine; Forensic Toxicology; Humans; Hyp | 2015 |
Which medications are safe and effective for improving sleep at high altitude?
Topics: Acetamides; Acetazolamide; Altitude Sickness; Anti-Anxiety Agents; Azabicyclo Compounds; Benzodiazep | 2008 |
Methods for the analysis of nonbenzodiazepine hypnotic drugs in biological matrices.
Topics: Acetamides; Azabicyclo Compounds; Chromatography, High Pressure Liquid; Electrophoresis, Capillary; | 2012 |
Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration.
Topics: Acetamides; Adult; Aged; Azabicyclo Compounds; Confidence Intervals; Eszopiclone; Female; Humans; Hy | 2012 |
Zopiclone and zaleplon vs benzodiazepines in the treatment of insomnia: Canadian consensus statement.
Topics: Acetamides; Anti-Anxiety Agents; Azabicyclo Compounds; Benzodiazepines; Canada; Consensus; Drug Inte | 2003 |
New drugs for insomnia: comparative tolerability of zopiclone, zolpidem and zaleplon.
Topics: Acetamides; Animals; Azabicyclo Compounds; Clinical Trials as Topic; Humans; Piperazines; Pyridines; | 2003 |
Clinically important drug interactions with zopiclone, zolpidem and zaleplon.
Topics: Acetamides; Antidepressive Agents; Antipsychotic Agents; Azabicyclo Compounds; Drug Interactions; Hi | 2003 |
[Drug treatment of sleep disorders in the elderly].
Topics: Acetamides; Aged; Aged, 80 and over; Antidepressive Agents; Antipsychotic Agents; Azabicyclo Compoun | 2003 |
Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysis.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Humans; Hypnotics and Sedatives; Piperazines; Pyr | 2004 |
The pharmacology and mechanisms of action of new generation, non-benzodiazepine hypnotic agents.
Topics: Acetamides; Animals; Azabicyclo Compounds; GABA-A Receptor Agonists; Humans; Hypnotics and Sedatives | 2004 |
Diagnosis and treatment of chronic insomnia: a review.
Topics: Acetamides; Benzodiazepines; Diagnostic and Statistical Manual of Mental Disorders; Health Status; H | 2005 |
Benefit-risk assessment of zaleplon in the treatment of insomnia.
Topics: Acetamides; Aged; Clinical Trials as Topic; Humans; Hypnotics and Sedatives; Memory; Psychomotor Per | 2005 |
Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review.
Topics: Accidental Falls; Acetamides; Aged; Aged, 80 and over; Azabicyclo Compounds; Benzodiazepines; Case-C | 2005 |
Insomnia in the elderly: cause, approach, and treatment.
Topics: Acetamides; Aged; Aging; Antidepressive Agents; Azabicyclo Compounds; Behavior Therapy; Benzodiazepi | 2006 |
The art of prescribing. Risks and benefits of non-benzodiazepine receptor agonists in the treatment of acute primary insomnia in older adults.
Topics: Acetamides; Acute Disease; Azabicyclo Compounds; Benzodiazepines; Causality; Drug Prescriptions; GAB | 2006 |
Hypnotic sedative drugs.
Topics: Acetamides; Azabicyclo Compounds; Chemistry, Pharmaceutical; Cost of Illness; Humans; Hypnotics and | 2007 |
Beyond benzodiazepines: alternative pharmacologic agents for the treatment of insomnia.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Clinical Protocols; Humans; Hypnotics and Sedativ | 1998 |
Zaleplon: a review of its use in the treatment of insomnia.
Topics: Acetamides; Drug Interactions; Humans; Hypnotics and Sedatives; Memory; Psychomotor Performance; Pyr | 2000 |
Zaleplon - a review of a novel sedative hypnotic used in the treatment of insomnia.
Topics: Acetamides; Anticonvulsants; Clinical Trials as Topic; Humans; Hypnotics and Sedatives; Pyrimidines; | 2000 |
Zaleplon: a pyrazolopyrimidine sedative-hypnotic agent for the treatment of insomnia.
Topics: Acetamides; Animals; Hypnotics and Sedatives; Pyrimidines; Randomized Controlled Trials as Topic; Sl | 2000 |
Implications of hypnotic flexibility on patterns of clinical use.
Topics: Acetamides; Benzodiazepines; Drug Tolerance; Forecasting; Humans; Hypnotics and Sedatives; Multicent | 2001 |
Individualizing therapy for early, middle-of-the-night and late-night insomnia.
Topics: Acetamides; Adolescent; Adult; Drug Administration Schedule; Female; Humans; Hypnotics and Sedatives | 2001 |
The relationship between psychiatric diseases and insomnia.
Topics: Acetamides; Depressive Disorder; Humans; Hypnotics and Sedatives; Memory Disorders; Pyrimidines; Sle | 2001 |
Efficacy and safety of zaleplon at peak plasma levels.
Topics: Acetamides; Humans; Hypnotics and Sedatives; Memory Disorders; Psychomotor Performance; Pyrimidines; | 2001 |
A psychiatric perspective on insomnia.
Topics: Acetamides; Benzodiazepines; Comorbidity; Depressive Disorder; Diagnosis, Differential; GABA-A Recep | 2001 |
Consequences of insomnia and its therapies.
Topics: Acetamides; Circadian Rhythm; Comorbidity; Half-Life; Health Status Indicators; Humans; Hypnotics an | 2001 |
Pyrazolopyrimidines.
Topics: Acetamides; Aged; Biological Availability; Child; Half-Life; Humans; Hypnotics and Sedatives; Psycho | 2001 |
Management of insomnia--the role of zaleplon.
Topics: Acetamides; Humans; Hypnotics and Sedatives; Peer Review; Pyrimidines; Risk Assessment; Sleep Initia | 2002 |
Safety of zaleplon in the treatment of insomnia.
Topics: Acetamides; Benzodiazepines; Half-Life; Humans; Hypnotics and Sedatives; Psychomotor Disorders; Pyri | 2002 |
13 trials available for zaleplon and Chronic Insomnia
| Article | Year |
|---|---|
Enhancement of zaleplon oral bioavailability using optimized self-nano emulsifying drug delivery systems and its effect on sleep quality among a sample of psychiatric patients.
Topics: Acetamides; Administration, Oral; Adult; Biological Availability; Cross-Sectional Studies; Drug Carr | 2019 |
Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
Topics: Acetamides; Adolescent; Adult; Azepines; Benzodiazepines; Female; Humans; Hypnotics and Sedatives; M | 2021 |
Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
Topics: Acetamides; Adolescent; Adult; Azepines; Benzodiazepines; Female; Humans; Hypnotics and Sedatives; M | 2021 |
Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
Topics: Acetamides; Adolescent; Adult; Azepines; Benzodiazepines; Female; Humans; Hypnotics and Sedatives; M | 2021 |
Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
Topics: Acetamides; Adolescent; Adult; Azepines; Benzodiazepines; Female; Humans; Hypnotics and Sedatives; M | 2021 |
Zaleplon increases nocturnal melatonin secretion in humans.
Topics: Acetamides; Adult; Circadian Rhythm; Cross-Over Studies; Double-Blind Method; Humans; Hypnotics and | 2009 |
Preference of insomniac patients between a single dose of zolpidem 10 mg versus zaleplon 10 mg.
Topics: Acetamides; Aged; Circadian Rhythm; Double-Blind Method; Female; Humans; Hypnotics and Sedatives; Ma | 2003 |
Zaleplon improves sleep quality in maintenance hemodialysis patients.
Topics: Acetamides; Adult; Aged; Cross-Over Studies; Double-Blind Method; Female; Humans; Hypnotics and Seda | 2003 |
"A comparison of the effectiveness of two hypnotic agents for the treatment of insomnia".
Topics: Acetamides; Administration, Oral; Adolescent; Adult; Aged; Drug Monitoring; Female; Humans; Hypnotic | 2004 |
Long-term use of sedative hypnotics in older patients with insomnia.
Topics: Acetamides; Aged; Aged, 80 and over; Double-Blind Method; Female; Humans; Hypnotics and Sedatives; M | 2005 |
Hypnotic discontinuation in chronic insomnia: impact of psychological distress, readiness to change, and self-efficacy.
Topics: Acetamides; Adaptation, Psychological; Adult; Aged; Anxiety; Attitude to Health; Azabicyclo Compound | 2008 |
Efficacy of L-846 in patients with insomnia: evaluation by polysomnography.
Topics: Acetamides; Adult; Aged; Dose-Response Relationship, Drug; Female; Humans; Hypnotics and Sedatives; | 1998 |
Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group.
Topics: Acetamides; Adolescent; Adult; Aged; Ambulatory Care; Dose-Response Relationship, Drug; Double-Blind | 1999 |
Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Zaleplon Clinical Study Group.
Topics: Acetamides; Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Female; | 2000 |
Zaleplon shortens subjective sleep latency and improves subjective sleep quality in elderly patients with insomnia. The Zaleplon Clinical Investigator Study Group.
Topics: Acetamides; Aged; Aged, 80 and over; Analysis of Variance; Dose-Response Relationship, Drug; Double- | 2000 |
Noise-induced sleep maintenance insomnia: hypnotic and residual effects of zaleplon.
Topics: Acetamides; Adult; Controlled Clinical Trials as Topic; Cross-Over Studies; Dose-Response Relationsh | 2002 |
40 other studies available for zaleplon and Chronic Insomnia
| Article | Year |
|---|---|
Treatment of Insomnia with Zaleplon in HIV+ Significantly Improves Sleep and Depression.
Topics: Acetamides; Depression; Depressive Disorder, Major; Humans; Pyrimidines; Quality of Life; Sleep; Sle | 2021 |
Zaleplon loaded bi-layered chronopatch: A novel buccal chronodelivery approach to overcome circadian rhythm related sleep disorder.
Topics: Acetamides; Administration, Buccal; Animals; Biological Availability; Capsules; Delayed-Action Prepa | 2018 |
Common Insomnia Drugs Receive Black Box Warning.
Topics: Acetamides; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Eszopiclone; Humans; Pyr | 2019 |
The formulation of a nasal nanoemulsion zaleplon in situ gel for the treatment of insomnia.
Topics: Acetamides; Acrylates; Administration, Intranasal; Animals; Biological Availability; Chemistry, Phar | 2013 |
[How well do Z-substances help in insomnia?].
Topics: Acetamides; Azabicyclo Compounds; Controlled Clinical Trials as Topic; Double-Blind Method; Eszopicl | 2013 |
Misuse of benzodiazepines and Z-drugs in the UK.
Topics: Acetamides; Adolescent; Adult; Anxiety; Azabicyclo Compounds; Benzodiazepines; Female; Humans; Hypno | 2014 |
Nonbenzodiazepine Sedative Hypnotics and Risk of Fall-Related Injury.
Topics: Accidental Falls; Acetamides; Aged; Aged, 80 and over; Brain Injuries, Traumatic; Cross-Over Studies | 2016 |
Hypnotics and skin cancer: hint at drug carcinogenesis, coincidence, or benefit of more sleep?
Topics: Acetamides; Animals; Azabicyclo Compounds; Carcinoma, Basal Cell; Eszopiclone; Humans; Indenes; Pipe | 2008 |
Possibility that certain hypnotics might cause cancer in skin.
Topics: Acetamides; Animals; Azabicyclo Compounds; Carcinoma, Basal Cell; Causality; Cross-Sectional Studies | 2008 |
Intranasal zaleplon abuse.
Topics: Acetamides; Administration, Intranasal; Adult; Affect; Dose-Response Relationship, Drug; Euphoria; H | 2008 |
Effect of hypnotic drugs on body balance and standing steadiness.
Topics: Acetamides; Adult; Aged; Alcohol Drinking; Azabicyclo Compounds; Benzodiazepines; Chronic Disease; D | 2010 |
Efficacy and safety of nonbenzodiazepine hypnotics for chronic insomnia in patients with bipolar disorder.
Topics: Acetamides; Adolescent; Adult; Azabicyclo Compounds; Bipolar Disorder; Eszopiclone; Female; Humans; | 2011 |
Insomnia: evidence-based approaches to assessment and management.
Topics: Acetamides; Azabicyclo Compounds; Cognitive Behavioral Therapy; Evidence-Based Medicine; Humans; Hyp | 2011 |
Sleep aid toxicosis in dogs: 317 cases (2004-2010).
Topics: Acetamides; Animals; Azabicyclo Compounds; Benzodiazepines; Comorbidity; Dog Diseases; Dogs; Eszopic | 2011 |
Pharmacokinetic evaluation of eszopiclone: clinical and therapeutic implications.
Topics: Acetamides; Adult; Aged; Azabicyclo Compounds; Clinical Trials as Topic; Cytochrome P-450 CYP3A; Cyt | 2012 |
Electroencephalographic properties of zaleplon, a non-benzodiazepine sedative/hypnotic, in rats.
Topics: Acetamides; Administration, Oral; Animals; Azabicyclo Compounds; Cerebral Cortex; Dose-Response Rela | 2004 |
Zaleplon overdose associated with sleepwalking and complex behavior.
Topics: Acetamides; Adolescent; Child Behavior Disorders; Depressive Disorder, Major; Drug Overdose; Drug Th | 2004 |
Perchance, to sleep...and then stay asleep.
Topics: Acetamides; Benzodiazepines; Diet; Exercise; Female; Humans; Hypnotics and Sedatives; Male; Pyridine | 2004 |
NICE: The National Institute of Clinical Excellence -- or Eccentricity? Reflections on the Z-drugs as hypnotics.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Half-Life; Humans; Hypnotics and Sedatives; Piper | 2005 |
NICE review: not nice for patients!
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Half-Life; Humans; Hypnotics and Sedatives; Piper | 2005 |
Making decisions in the absence of high quality clinical evidence: we need to bring some science into the judgement.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Drug Costs; Humans; Hypnotics and Sedatives; Pipe | 2005 |
Short-term treatment with hypnotic drugs for insomnia: going beyond the evidence.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Cost-Benefit Analysis; Evidence-Based Medicine; H | 2005 |
A NICE missed opportunity?
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Drug Tolerance; Humans; Hypnotics and Sedatives; | 2005 |
Consultation corner. Are the new sleep aids right for you?
Topics: Acetamides; Azabicyclo Compounds; Humans; Hypnotics and Sedatives; Indenes; Piperazines; Pyridines; | 2006 |
Meds and the restless search for sleep.
Topics: Acetamides; Aged; Azabicyclo Compounds; Humans; Hypnotics and Sedatives; Piperazines; Pyridines; Pyr | 2006 |
Commentary on a critique for the Journal of Psychopharmacology: NICE--excellence or eccentricity? Reflections on the z-drugs as hypnotics review.
Topics: Acetamides; Azabicyclo Compounds; Benzodiazepines; Humans; Hypnotics and Sedatives; Piperazines; Pra | 2007 |
Greater incidence of depression with hypnotic use than with placebo.
Topics: Acetamides; Azabicyclo Compounds; Cross-Sectional Studies; Depressive Disorder, Major; Drug Prescrip | 2007 |
Dose-related illusions and hallucinations with zaleplon.
Topics: Acetamides; Adult; Depersonalization; Dose-Response Relationship, Drug; Female; Hallucinations; Huma | 2008 |
What every dentist should know about the "z-sedatives".
Topics: Acetamides; Azabicyclo Compounds; Drug Interactions; Eszopiclone; Humans; Hypnotics and Sedatives; P | 2007 |
Magic bullets for insomnia? Patients' use and experiences of newer (Z drugs) versus older (benzodiazepine) hypnotics for sleep problems in primary care.
Topics: Acetamides; Adolescent; Adult; Aged; Aged, 80 and over; Attitude to Health; Azabicyclo Compounds; Be | 2008 |
From the Food and Drug Administration.
Topics: Acetamides; Dietary Supplements; Humans; Hypnotics and Sedatives; Pneumonia, Bacterial; Pyrimidines; | 1999 |
Zaleplon for insomnia.
Topics: Acetamides; Aged; Amnesia; Dose-Response Relationship, Drug; Drug Interactions; Humans; Hypnotics an | 1999 |
A new option for insomnia.
Topics: Acetamides; Humans; Hypnotics and Sedatives; Pyrimidines; Sleep Initiation and Maintenance Disorders | 1999 |
[Pharma-clinics. Drug of the month. Zaleplon (Sonata)].
Topics: Acetamides; Dose-Response Relationship, Drug; Half-Life; Humans; Hypnotics and Sedatives; Pyrimidine | 1999 |
New insomnia drug. Are there any medications to treat insomnia that won't leave me feeling groggy the next day?
Topics: Acetamides; Humans; Hypnotics and Sedatives; Pyrimidines; Sleep Initiation and Maintenance Disorders | 2000 |
Hypnotic drugs.
Topics: Acetamides; Administration, Oral; Alcohol Drinking; Barbiturates; Chloral Hydrate; Ethchlorvynol; GA | 2000 |
Perceptual disturbances with zaleplon.
Topics: Acetamides; Adult; Depersonalization; Dose-Response Relationship, Drug; Female; Hallucinations; Huma | 2001 |
Treatment of insomnia with zaleplon, a novel sleep medication.
Topics: Acetamides; Aged; Clinical Trials as Topic; Humans; Hypnotics and Sedatives; Pyrimidines; Sleep Init | 2001 |
Treatment for insomnia.
Topics: Acetamides; Cognition; Humans; Hypnotics and Sedatives; Postural Balance; Problem Solving; Psychomot | 2002 |
Treatment for insomnia.
Topics: Acetamides; Aged; Drug Administration Schedule; Humans; Hypnotics and Sedatives; Middle Aged; Patien | 2002 |