PT  - JOURNAL ARTICLE
AU  - W. Joseph Herring
AU  - Ellen Snyder
AU  - Kerry Budd
AU  - Jill Hutzelmann
AU  - Duane Snavely
AU  - Kenneth Liu
AU  - Christopher Lines
AU  - Thomas Roth
AU  - David Michelson
TI  - Orexin receptor antagonism for treatment of insomnia
AID  - 10.1212/WNL.0b013e31827688ee
DP  - 2012 Dec 04
TA  - Neurology
PG  - 2265--2274
VI  - 79
IP  - 23
4099  - http://n.neurology.org/content/79/23/2265.short
4100  - http://n.neurology.org/content/79/23/2265.full
SO  - Neurology2012 Dec 04; 79
AB  - 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.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