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

Alzheimers Dement. 2020 Mar;16(3):541-551. doi: 10.1002/alz.12035. Epub 2020 Jan 15.


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.

Trial registration: ClinicalTrials.gov NCT02750306.

Keywords: Alzheimer's disease; insomnia; randomized clinical trial; suvorexant.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alzheimer Disease / psychology*
  • Azepines / administration & dosage*
  • Female
  • Humans
  • Male
  • Polysomnography*
  • Sleep / drug effects*
  • Sleep Aids, Pharmaceutical / administration & dosage*
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Triazoles / administration & dosage*


  • Azepines
  • Sleep Aids, Pharmaceutical
  • Triazoles
  • suvorexant

Associated data

  • ClinicalTrials.gov/NCT02750306