Journal
JOURNAL OF CLINICAL SLEEP MEDICINE
Volume 12, Issue 9, Pages 1215-1225Publisher
AMER ACAD SLEEP MEDICINE
DOI: 10.5664/jcsm.6116
Keywords
insomnia; sleep; orexin; suvorexant; randomized controlled trial; pharmacotherapy
Categories
Funding
- Merck Co., Inc.
- Kenilworth, NJ, USA
- Merck
- NIH
- Teva
- Sunovion
- Astellas
- Abbott
- Neosync
- Brainsway
- Janssen
- ANS St. Jude
- Novartis
- Apnex
- Novo Nordisk
- Respironics
- Vanda
- Aventis
- Cephalon
- GlaxoSmithKline
- Neurocrine
- Pfizer
- Sanofi
- Schering-Plough
- Sepracor
- Somaxon
- Syrex
- Takeda
- TransOral
- Wyeth
- Xenoport
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Study Objectives: Suvorexant 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. Methods: Prespecified 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. Results: Suvorexant 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. Conclusions: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.
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