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ABSTRACT
Objective: To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia.
Methods: 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.
Results: 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.
Conclusions: The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia.
Classification of evidence: This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.
Glossary
- DSM-IV-TR=
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision;
- DSCT=
- Digit Symbol Copying Test;
- DSST=
- Digit Symbol Substitution Test;
- LPS=
- latency to persistent sleep;
- PSG=
- polysomnography;
- SE=
- sleep efficiency;
- sTSO=
- subjective time to sleep onset;
- sTST=
- subjective total sleep time;
- TST=
- total sleep time;
- WASO=
- wake after sleep onset
Footnotes
Coinvestigators are listed on the Neurology® Web site at www.neurology.org.
Study funding: Supported by Merck Research Laboratories. The funding organization was involved in the following: design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Go to Neurology.org for full disclosures. Disclosures deemed relevant by the authors, if any, are provided at the end of this article.
Supplemental data at www.neurology.org
- Received January 5, 2012.
- Accepted July 30, 2012.
- © 2012 American Academy of Neurology
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