Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant.

To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia.
We evaluated suvorexant, an orexin receptor antagonist, for treating patients with primary insomnia in a randomized, double-blind, placebo-controlled, 2-period (4 weeks per period) crossover polysomnography study. Patients received suvorexant (10 mg [n = 62], 20 mg [n = 61], 40 mg [n = 59], or 80 mg [n = 61]) in one period and placebo (n = 249) in the other. Polysomnography was performed on night 1 and at the end of week 4 of each period. The coprimary efficacy end points were sleep efficiency on night 1 and end of week 4. Secondary end points were wake after sleep onset and latency to persistent sleep.
Suvorexant showed significant (p values <0.01) dose-related improvements vs placebo on the coprimary end points of sleep efficiency at night 1 and end of week 4. Dose-related effects were also observed for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). Suvorexant was generally well tolerated.
The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia.
This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.
AuthorsW Joseph Herring, Ellen Snyder, Kerry Budd, Jill Hutzelmann, Duane Snavely, Kenneth Liu, Christopher Lines, Thomas Roth, David Michelson
JournalNeurology (Neurology) Vol. 79 Issue 23 Pg. 2265-74 (Dec 4 2012) ISSN: 1526-632X [Electronic] United States
PMID23197752 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Azepines
  • Hypnotics and Sedatives
  • Orexin Receptors
  • Receptors, G-Protein-Coupled
  • Receptors, Neuropeptide
  • Triazoles
  • suvorexant
  • Adolescent
  • Adult
  • Azepines (pharmacology, therapeutic use)
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives (pharmacology, therapeutic use)
  • Male
  • Middle Aged
  • Orexin Receptors
  • Polysomnography
  • Receptors, G-Protein-Coupled (antagonists & inhibitors)
  • Receptors, Neuropeptide (antagonists & inhibitors)
  • Sleep (drug effects, physiology)
  • Sleep Initiation and Maintenance Disorders (drug therapy, physiopathology)
  • Treatment Outcome
  • Triazoles (pharmacology, therapeutic use)

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