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Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.

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

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1
Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. william.herring@merck.com

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.

PMID:
23197752
DOI:
10.1212/WNL.0b013e31827688ee
[Indexed for MEDLINE]
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