ArticleSleep and biological rhythms2026
Effects of daridorexant on sleep architecture in Japanese patients with insomnia disorder: analysis of a phase II randomized controlled trial.
Article in Sleep and biological rhythms, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
While daridorexant, a dual orexin receptor antagonist (DORA), demonstrated dose-dependent improvements in sleep parameters in a Japanese Phase II trial, its effects on sleep architecture remain incompletely characterized. This secondary analysis examined daridorexant's effects on sleep fragmentation and architecture in Japanese patients with insomnia disorder. Forty-seven Japanese patients with insomnia (mean age 50.4 ± 8.0 years) underwent 10 nights of polysomnographic (PSG) recordings in a randomized protocol (baseline, placebo, daridorexant 10 mg, 25 mg, 50 mg; 2 nights each). Key parameters included latency to persistent sleep (LPS), total sleep time (TST), wake after sleep onset (WASO), sleep stage durations, and the number of persistent awakenings (NAW). The 8-hour recording was divided into quarters for temporal analysis. Dose-response trends were assessed using Jonckheere-Terpstra tests. Significant dose-response relationships were observed for LPS ( Supplementary Information: The online version contains supplementary material available at 10.1007/s41105-025-00628-2.
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