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Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Herring, W Joseph ; Connor, Kathleen M ; Snyder, Ellen ; Snavely, Duane B ; Zhang, Ying ; Hutzelmann, Jill ; Matzura-Wolfe, Deborah ; Benca, Ruth M ; Krystal, Andrew D ; Walsh, James K ; Lines, Christopher ; Roth, Thomas ; Michelson, David

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2016-09, Vol.12 (9), p.1215-1225

eScholarship, University of California

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Título:
Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials
Autor: Herring, W Joseph ; Connor, Kathleen M ; Snyder, Ellen ; Snavely, Duane B ; Zhang, Ying ; Hutzelmann, Jill ; Matzura-Wolfe, Deborah ; Benca, Ruth M ; Krystal, Andrew D ; Walsh, James K ; Lines, Christopher ; Roth, Thomas ; Michelson, David
Assuntos: 6.1 Pharmaceuticals ; Adolescent ; Adult ; Aged ; Aging ; Azepines ; Clinical Research ; Clinical Sciences ; Clinical Trials and Supportive Activities ; Dose-Response Relationship ; Double-Blind Method ; Drug ; Evaluation of treatments and therapeutic interventions ; Female ; Humans ; insomnia ; Male ; Middle Aged ; Neurology & Neurosurgery ; Neurosciences ; orexin ; Other Medical and Health Sciences ; Pharmaceutical ; pharmacotherapy ; Psychology ; randomized controlled trial ; sleep ; Sleep Aids ; Sleep Initiation and Maintenance Disorders ; Sleep Research ; suvorexant ; Treatment Outcome ; Triazoles ; Young Adult
É parte de: Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2016-09, Vol.12 (9), p.1215-1225
Notas: 1215 - 1225
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, vol 12, iss 9
Descrição: Study objectivesSuvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials.MethodsPrespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints.ResultsSuvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use.ConclusionsSuvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.Clinical trial registrationClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629.
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Idioma: Inglês

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Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Herring, W Joseph ; Connor, Kathleen M ; Snyder, Ellen ; Snavely, Duane B ; Zhang, Ying ; Hutzelmann, Jill ; Matzura-Wolfe, Deborah ; Benca, Ruth M ; Krystal, Andrew D ; Walsh, James K ; Lines, Christopher ; Roth, Thomas ; Michelson, David

eScholarship, University of California

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