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

Research output: Contribution to journalArticle

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 5 62], 20 mg [n 5 61], 40 mg [n 5 59], or 80 mg [n 5 61]) in one period and placebo (n 5 249) 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.

Original languageEnglish (US)
Pages (from-to)2265-2274
Number of pages10
JournalNeurology
Volume79
Issue number23
DOIs
StatePublished - Dec 4 2012
Externally publishedYes

Fingerprint

Orexin Receptors
Sleep Initiation and Maintenance Disorders
Sleep
Randomized Controlled Trials
Polysomnography
Placebos
Therapeutics
suvorexant
Clinical Trials
Antagonism
Cross-Over Studies
Maintenance

ASJC Scopus subject areas

  • Clinical Neurology
  • Arts and Humanities (miscellaneous)

Cite this

Herring, W. J., Snyder, E., Budd, K., Hutzelmann, J., Snavely, D., Liu, K., ... Michelson, D. (2012). Orexin receptor antagonism for treatment of insomnia: A randomized clinical trial of suvorexant. Neurology, 79(23), 2265-2274. https://doi.org/10.1212/WNL.0b013e31827688ee

Orexin receptor antagonism for treatment of insomnia : A randomized clinical trial of suvorexant. / Herring, W. Joseph; Snyder, Ellen; Budd, Kerry; Hutzelmann, Jill; Snavely, Duane; Liu, Kenneth; Lines, Christopher; Roth, Thomas; Michelson, David.

In: Neurology, Vol. 79, No. 23, 04.12.2012, p. 2265-2274.

Research output: Contribution to journalArticle

Herring, WJ, Snyder, E, Budd, K, Hutzelmann, J, Snavely, D, Liu, K, Lines, C, Roth, T & Michelson, D 2012, 'Orexin receptor antagonism for treatment of insomnia: A randomized clinical trial of suvorexant', Neurology, vol. 79, no. 23, pp. 2265-2274. https://doi.org/10.1212/WNL.0b013e31827688ee
Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K et al. Orexin receptor antagonism for treatment of insomnia: A randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-2274. https://doi.org/10.1212/WNL.0b013e31827688ee
Herring, W. Joseph ; Snyder, Ellen ; Budd, Kerry ; Hutzelmann, Jill ; Snavely, Duane ; Liu, Kenneth ; Lines, Christopher ; Roth, Thomas ; Michelson, David. / Orexin receptor antagonism for treatment of insomnia : A randomized clinical trial of suvorexant. In: Neurology. 2012 ; Vol. 79, No. 23. pp. 2265-2274.
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