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

Herring, W. Joseph, Ceesay, Paulette, Snyder, Ellen, Bliwise, Donald, Budd, Kerry, Hutzelmann, Jill, Stevens, Joanne, Lines, Christopher, Michelson, David·2020·Alzheimer's & Dementia

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.

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  • Most therapies approved for Alzheimer's disease are indicated to only treat symptoms: acetylcholinesterase inhibitors, a glutamatergic modulator (memantine), and an orexin receptor antagonist (suvorexant) for Alzheimer-related insomnia.

    “Most therapies approved for Alzheimer’s disease are indicated to only treat the symptoms of Alzheimer’s disease: acetylcholinesterase inhibitors, a glutamatergic modulator (memantine), and an orexin receptor antagonist (suvorexant) for Alzheimer-related insomnia [21,22].”

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Metadata

Authors
Herring, W. J., Ceesay, P., Snyder, E., Bliwise, D., Budd, K., Hutzelmann, J., Stevens, J., Lines, C., & Michelson, D.
Affiliations
  • Merck &amp; Co., Inc. Kenilworth New Jersey
  • Sleep Center Emory University School of Medicine Atlanta Georgia
Venue
Alzheimer's & Dementia
Publisher
Wiley
Published
2020-01-15
Volume
16
Issue
3
Pages
541-551
ISSN
  • 1552-5260
  • 1552-5279
Cited by
185
References
7
Language
en
Funders
Merck Sharp and Dohme

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