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Data from: Daridorexant, a new dual orexin receptor antagonist in elderly subjects with insomnia disorder: a randomized clinical trial

Citation

Zammit, Gary et al. (2021), Data from: Daridorexant, a new dual orexin receptor antagonist in elderly subjects with insomnia disorder: a randomized clinical trial, Dryad, Dataset, https://doi.org/10.5061/dryad.qnk98sfbw

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) subjects (n = 58) with insomnia were randomly allocated (Latin square design) to receive five treatments (5, 10, 25, and 50 mg daridorexant and placebo) during five treatment periods, each consisting of two treatment nights followed by a 5–12-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&2 (mean of two treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.

Results: Of 58 subjects included, 67% were female and median age was 69 years [range 65–85]). WASO and LPS were dose-dependently reduced from baseline to Days 1&2 following daridorexant administration (multiple comparison procedure-modeling, p<0.0001 and p=0.004, respectively); reductions were statistically significant for doses 10 mg and above compared with placebo (WASO: –32.0, –45.1, –61.4 min; LPS: –44.9, –43.8, –45.4 min; 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 subjects with insomnia disorder. ClinicalTrials.gov (NCT02841709).

Classification of Evidence: This study provides Class III evidence that for elderly subjects with insomnia, daridorexant reduced wake after sleep onset time.