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.
RCT Entities:
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.
Authors: W Joseph Herring; Kathleen M Connor; Ellen Snyder; Duane B Snavely; Ying Zhang; Jill Hutzelmann; Deborah Matzura-Wolfe; Ruth M Benca; Andrew D Krystal; James K Walsh; Christopher Lines; Thomas Roth; David Michelson Journal: J Clin Sleep Med Date: 2016-09-15 Impact factor: 4.062
Authors: Benjamin A Juneau; Jamie M Stonemetz; Ryan F Toma; Debra R Possidente; R Conor Heins; Christopher G Vecsey Journal: Physiol Behav Date: 2019-03-29
Authors: W Joseph Herring; Kathryn M Connor; Ellen Snyder; Duane B Snavely; Ying Zhang; Jill Hutzelmann; Deborah Matzura-Wolfe; Ruth M Benca; Andrew D Krystal; James K Walsh; Christopher Lines; Thomas Roth; David Michelson Journal: Psychopharmacology (Berl) Date: 2017-03-07 Impact factor: 4.530