RT Journal Article
SR Electronic
T1 Orexin receptor antagonism for treatment of insomnia
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 2265
OP 2274
DO 10.1212/WNL.0b013e31827688ee
VO 79
IS 23
A1 W. Joseph Herring
A1 Ellen Snyder
A1 Kerry Budd
A1 Jill Hutzelmann
A1 Duane Snavely
A1 Kenneth Liu
A1 Christopher Lines
A1 Thomas Roth
A1 David Michelson
YR 2012
UL http://n.neurology.org/content/79/23/2265.abstract
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