Polysomnographic assessment of suvorexant in patients with probable Alzheimer's disease dementia and insomnia: a randomized trial

• Type of Material: Article
• Authors: Joseph W Herring, Merck & Co Inc; Paulette Ceesay, Merck & Co Inc; Ellen Snyder, Merck & Co Inc; Donald Bliwise, Emory University; Kerry Budd, Merck & Co Inc; Jill Hutzelmann, Merck & Co Inc; Joanne Stevens, Merck & Co Inc; Christopher Lines, Merck & Co Inc; David Michelson, Merck & Co Inc
• Language: English
• Date: 2020-03-01
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2020 The Authors. Alzheimer's & Dementia published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/alz.12035
• Title of Journal or Parent Work: ALZHEIMERS & DEMENTIA
• Volume: 16
• Issue: 3
• Start Page: 541
• End Page: 551
• Grant/Funding Information: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
• Keywords: SLEEP DISTURBANCE; randomized clinical trial; Alzheimer's disease; insomnia; Neurosciences & Neurology; OREXIN-A; suvorexant; Science & Technology; DISORDERS; PLACEBO-CONTROLLED TRIAL; CEREBROSPINAL-FLUID LEVELS; RISPERIDONE; IMPROVE SLEEP; Clinical Neurology; POOLED ANALYSES; MELATONIN; Life Sciences & Biomedicine; DOUBLE-BLIND
• Research Categories: Health Sciences, Public Health

Abstract

Introduction: We evaluated the clinical profile of the orexin receptor antagonist suvorexant for treating insomnia in patients with mild-to-moderate probable Alzheimer's disease (AD) dementia. Methods: Randomized, double-blind, 4-week trial of suvorexant 10 mg (could be increased to 20 mg based on clinical response) or placebo in patients who met clinical diagnostic criteria for both probable AD dementia and insomnia. Sleep was assessed by overnight polysomnography in a sleep laboratory. The primary endpoint was change-from-baseline in polysomnography-derived total sleep time (TST) at week 4. Results: Of 285 participants randomized (suvorexant, N = 142; placebo, N = 143), 277 (97%) completed the trial (suvorexant, N = 136; placebo, N = 141). At week 4, the model-based least squares mean improvement-from-baseline in TST was 73 minutes for suvorexant and 45 minutes for placebo; (difference = 28 minutes [95% confidence interval 11-45], p < 0.01). Somnolence was reported in 4.2% of suvorexant-treated patients and 1.4% of placebo-treated patients. Discussion: Suvorexant improved TST in patients with probable AD dementia and insomnia.