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December 04, 2012; 79 (23) Article

Orexin receptor antagonism for treatment of insomnia

A randomized clinical trial of suvorexant

W. Joseph Herring, Ellen Snyder, Kerry Budd, Jill Hutzelmann, Duane Snavely, Kenneth Liu, Christopher Lines, Thomas Roth, David Michelson
First published November 28, 2012, DOI: https://doi.org/10.1212/WNL.0b013e31827688ee
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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.
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