Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial

作者：Zhaoyang Huang, Hanqiao Wang, Bin Zhang, Chenyu Li, Jian Wang, Lijun Xu, Qi Xu, Jing Chen, Xiao Li, Zan Wang, Bei Wang, Yan Jiang, Yun-lin Liu, Chengmei Yuan, Qinying Ma, Juncang Wu, Xin Liu, Yuansheng Huang, Hao Cui, Feng Wang, Yuping Wang · 发表于：SLEEP · 年份：2025 · DOI：10.1093/sleep/zsaf170 · 被引用次数：4 · 研究领域：Sleep and related disorders、Sleep and Wakefulness Research、Restless Legs Syndrome Research

STUDY OBJECTIVES: To evaluate the efficacy and safety of daridorexant in Chinese patients with insomnia disorder. METHODS: This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III clinical trial in China. Adults aged 18-75 years meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder, with a baseline Insomnia Severity Index (ISI) more than equal to 15, were randomly assigned in a 1:1 ratio to receive daridorexant 50 mg or placebo once every evening for 1 month. The primary endpoint was the change from baseline to month 1 in wake time after sleep onset (WASO) assessed by polysomnography (PSG). The secondary endpoints included the change from baseline to month 1 in self-reported total sleep time (sTST) and in latency to persistent sleep (LPS). In addition to the standardized collection of adverse events (AEs), safety data specific to insomnia treatment were assessed as follows: withdrawal symptoms, rebound insomnia, and next-day residual effects. RESULTS: Two hundred and six participants were enrolled and evenly randomized to each group. Compared with the placebo group, the daridorexant group showed a significant reduction in WASO (-15.4 min, p = .0009), a significant increase in sTST (16.8 min, p = .021) and a significant reduction in LPS (geometric mean ratio to placebo 0.7, p = .001) from baseline to month 1. The proportion of participants reporting AEs during double-blind t...