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

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

Source : https://pubmed.ncbi.nlm.nih.gov/36098936/

doi: 10.1007/s40266-022-00977-4. Online ahead of print. 1 Center for Sleep Medicine, Charité, University Hospital Berlin, Berlin, Germany. 2 Department of Medicine, The Fourth People's Hospital of Guangyuan City, Guangyuan, China. 3 Department of Neurology, Inselspital, University of Bern, Bern, Switzerland. 4 CTI Clinical Research Center, Cincinnati, OH, USA.


Conclusions: In older patients with insomnia, as in younger patients, the efficacy of daridorexant is maximal on night-time and daytime variables at the higher dose of 50 mg. Older patients particularly require this dose to improve daytime functioning. Older patients are not at an increased risk of adverse events or residual effects the next morning after night-time administration of daridorexant, even at 50 mg. The dose of daridorexant does not need to be decreased for older patients.

  • September 20, 2022
    Key Points
    • Source: Drugs & Aging
    • Conclusion: “In older patients with insomnia, as in younger patients, the efficacy of daridorexant is maximal on night-time and daytime variables at the higher dose of 50 mg. Older patients particularly require this dose to improve daytime functioning. Older patients are not at an increased risk of adverse events or residual effects the next morning after night-time administration of daridorexant, even at 50 mg. The dose of daridorexant does not need to be decreased for older patients.”
    • In the current study, U.S. researchers performed a secondary analysis (n=364) of the daridorexant phase III development programme to compare and contrast the safety and efficacy of daridorexant at 50 mg and 25 mg between older and younger insomnia patients.
    • In older adults 50 mg daridorexant improved sleep onset, sleep maintenance, and objective/subjective total sleep time, as well as daytime functioning with regard to alertness, sleepiness, and mood.
    • Limitations of the current study include its post hoc nature and small sample size.