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Efficacy and Safety of Daridorexant in Chinese Patients with Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial

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机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [2]Beijing Key Laboratory of Neuromodulation, Beijing, China. [3]Department of Sleep Medicine, The Third Hospital of Hebei Medical University, Shijiazhuang, China. [4]Department of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, Guangzhou, China. [5]Department of Neurology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, China. [6]Chengdu Second People's Hospital, Chengdu, China. [7]Department of Neurology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. [8]Department of Neurology, Xianyang Hospital of Yan'an University, Xianyang, China. [9]Beijing Huilongguan Hospital, Peking University Huilongguan Clinical Medical School, Beijing, China. [10]Sleep Medicine Center, Shengjing Hospital of China Medical University, Shenyang, China. [11]Sleep Centre, Department of Neurology, Bethune First Hospital of Jilin University, Changchun, China. [12]Sleep Medicine Center of PCCM, The Second Hospital of Shanxi Medical University, Taiyuan, China. [13]Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China. [14]Department of Neurology, Tai'an Central Hospital, Tai'an, China. [15]Sleep disorder diagnosis and treatment center, Department of Clinical Psychology, Shanghai Mental Health Center, Shanghai, China. [16]Department of Neurology, The First Hospital of Hebei Medical University, Shijiazhuang, China. [17]Department of Neurology, The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, Hefei, China. [18]Jiangsu Simcere Pharmaceutical Co. Ltd, Tianjin, China. [19]Jiangsu Simcere Pharmaceutical Co. Ltd, Beijing, China. [20]Jiangsu Simcere Pharmaceutical Co. Ltd, Nanjing, China. [21]State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China. [22]Beijing Key Laboratory of Neuromodulation, Capital Medical University, Beijing, China. [23]Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Ministry of Science and Technology, Beijing, China. [24]Institute of sleep and consciousness disorders, Beijing Institute of Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.

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关键词： Insomnia Disorder Daridorexant Efficacy Safety Dual Orexin Receptor Antagonist

摘要：

To evaluate the efficacy and safety of daridorexant in Chinese patients with insomnia disorder.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) ≥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 subjective total sleep time (sTST) and in latency to persistent sleep (LPS). In addition to the standardized collection of AEs, safety data specific to insomnia treatment were assessed as follows: withdrawal symptoms, rebound insomnia, and next-day residual effects.206 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 treatment was generally comparable between two groups (21.6% vs. 18.4%), with no notable safety signals observed. No withdrawal symptoms, rebound insomnia, and next-day residual effects were observed.Daridorexant 50 mg significantly improved both objective and subjective sleep outcomes in Chinese patients with insomnia disorder, with a favorable safety profile.© The Author(s) 2025. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our siteâ€”for further information please contact journals.permissions@oup.com.

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大类 | 2 区医学

小类 | 2 区临床神经病学 2 区神经科学

最新[2025]版：

大类 | 2 区医学

小类 | 2 区临床神经病学 2 区神经科学

第一作者：

第一作者机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [2]Beijing Key Laboratory of Neuromodulation, Beijing, China.

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通讯作者：

通讯机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [22]Beijing Key Laboratory of Neuromodulation, Capital Medical University, Beijing, China. [23]Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Ministry of Science and Technology, Beijing, China. [24]Institute of sleep and consciousness disorders, Beijing Institute of Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.

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Efficacy and Safety of Daridorexant in Chinese Patients with Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial

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