A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Phase 3 Completed 206 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters .

Timeline

Start: 2023-08-28
Primary completion: 2024-04-12
Completion: 2024-05-10

Outcome

Met primary endpoint

release “the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets (Daridorexant), for the treatment of insomnia patients in China, has met the primary study endpoint.” simcere.com ↗

release “Primary endpoint：Significant improvement in sleep maintenance Wake After Sleep Onset (WASO) measured by PSG” simcere.com ↗

Publications

Huang Z, Wang H, Zhang B, Li C, Wang J, Xu L, Xu Q, Chen J, Xiao L, Wang Z, Wang B, Jiang Y, Liu Y, Yuan C, Ma Q, Wu J, Liu X, Huang Y, Cui H, Wang F, Wang Y. Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Sleep. 2025 Dec 11;48(12):zsaf170. doi: 10.1093/sleep/zsaf170.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	50 mg	Oral