Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial

Background and Objective The dual orexin receptor antagonist daridorexant, studied in two phase III trials, dose-dependently improved objective and subjective sleep variables and daytime functioning in adults with insomnia. Because treatment of insomnia in older adults is challenging and has limited...

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Bibliographic Details
Published in:Drugs & aging 2022-10, Vol.39 (10), p.795-810
Main Authors: Fietze, Ingo, Bassetti, Claudio L. A., Mayleben, David W., Pain, Scott, Seboek Kinter, Dalma, McCall, William V.
Format: Article
Language:English
Subjects:
Adults
Age groups
Aged
Clinical outcomes
Clinical trials
Cognition & reasoning
Double-Blind Method
Geriatrics/Gerontology
Humans
Imidazoles
Insomnia
Internal Medicine
Lipopolysaccharides
Medicine
Medicine & Public Health
NCT
NCT03545191
Older people
Orexin Receptor Antagonists - adverse effects
Original
Original Research Article
Patient safety
Patients
Pharmacology/Toxicology
Pharmacotherapy
Pyrrolidines
Questionnaires
Sleep
Sleep Initiation and Maintenance Disorders - drug therapy
Sleepiness
Treatment Outcome
Young adults
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Summary:Background and Objective The dual orexin receptor antagonist daridorexant, studied in two phase III trials, dose-dependently improved objective and subjective sleep variables and daytime functioning in adults with insomnia. Because treatment of insomnia in older adults is challenging and has limited options, the purpose of the current analysis was to further analyse the phase III trial studying the higher doses of daridorexant, those that showed efficacy (daridorexant 50 mg, daridorexant 25 mg and placebo, nightly for 3 months), and compare the safety and efficacy of daridorexant in patients aged ≥ 65 (‘older adults’) to those aged
ISSN:1170-229X
1179-1969
DOI:10.1007/s40266-022-00977-4