Article2020

Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder

Gary K Zammit · Yves A Dauvilliers · Scott Pain · Dalma Seboek Kinter · Yosef T. Mansour · Dieter Kunz

104 citations0/0 files storedNeurology

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Abstract

Objective To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO). Methods Elderly (≥65 years) participants (n = 58) with insomnia were randomly allocated (Latin square design) to receive 5 treatments (5, 10, 25, and 50 mg daridorexant and placebo) during 5 treatment periods, each consisting of 2 treatment nights followed by a 5- to 12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed. Results Of 58 participants included, 67% were female, and the median age was 69 years (range 65–85 years). WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling, p < 0.0001 and p = 0.004, respectively); reductions were statistically significant for doses ≥10 mg compared with placebo (WASO: −32.0, −45.1, −61.4 minutes; LPS: −44.9, −43.8, −45.4 minutes for 10, 25, and 50 mg, respectively, p ≤ 0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group). Conclusions Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10–50 mg) in elderly people with insomnia disorder. ClinicalTrials.gov identifier: NCT02841709. Classification of evidence This study provides Class I evidence that, for elderly people with insomnia, daridorexant reduced WASO.

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References

2013Diagnostic and Statistical Manual of Mental Disorders 2007The American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications 2011The Insomnia Severity Index: Psychometric Indicators to Detect Insomnia Cases and Evaluate Treatment Response 1990Subjective and Objective Sleepiness in the Active Individual 2017Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline 2007Comorbidity of Chronic Insomnia With Medical Problems 2006Poor Sleep Is Associated With Impaired Cognitive Function in Older Women: The Study of Osteoporotic Fractures 2016Review of Safety and Efficacy of Sleep Medicines in Older Adults

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2020Clinical pharmacology, efficacy, and safety of orexin receptor antagonists for the treatment of insomnia disorders 2021The efficacy and safety of dual orexin receptor antagonists in primary insomnia: A systematic review and network meta-analysis 2022Daridorexant: First Approval 2021Advances in the Treatment of Chronic Insomnia: A Narrative Review of New Nonpharmacologic and Pharmacologic Therapies

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