Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
A Study of Daridorexant in Chinese Patients With Insomnia Disorder, https://clinicaltrials.gov/study/NCT06010693, with the number NCT06010693. Statement of Significance Daridorexant has been evaluated and approved for the treatment of insomnia in many countries worldwide, but there is no data of daridorexant in Chinese populations. This study is the first randomized controlled phase III study of daridorexant in Chinese. It verified the efficacy and safety of daridorexant in Chinese people for the first time and fully explained the characteristics of daridorexant in Chinese patients with insomnia. This study provides a basis for the approval of daridorexant for clinical use in China, as well as reference data for clinicians to use the drug in the future.
Authors
- Hanqiao Wang
- Juncang Wu (ORCID: https://orcid.org/0000-0002-2632-5757)
- Yuansheng Huang (ORCID: https://orcid.org/0000-0001-5105-9780)
- Feng Wang (ORCID: https://orcid.org/0000-0002-7386-7575)
- Zhaoyang Huang (ORCID: https://orcid.org/0009-0007-2514-3533)
- Hao Cui (ORCID: https://orcid.org/0000-0001-7634-748X)
- Yuping Wang (ORCID: https://orcid.org/0000-0002-6482-9710)
- Bei Wang (ORCID: https://orcid.org/0000-0001-6840-5133)
- Xin Liu (ORCID: https://orcid.org/0000-0002-2207-4356)
- Chenyu Li (ORCID: https://orcid.org/0000-0001-7879-8612)
- Jian Wang (ORCID: https://orcid.org/0000-0003-2291-640X)
- Xiao Li (ORCID: https://orcid.org/0000-0002-7708-2193)
- Bin Zhang (ORCID: https://orcid.org/0000-0003-1303-2397)
- Zan Wang (ORCID: https://orcid.org/0000-0003-4770-2803)
- Chengmei Yuan (ORCID: https://orcid.org/0000-0002-8696-717X)
- Lijun Xu (ORCID: https://orcid.org/0000-0003-0455-410X)
- Yan Jiang (ORCID: https://orcid.org/0000-0002-7042-6758)
- Qi Xu (ORCID: https://orcid.org/0000-0003-2660-8092)
- Yun-lin Liu (ORCID: https://orcid.org/0000-0003-3015-3916)
- Jing Chen (ORCID: https://orcid.org/0000-0003-2395-6120)
- Qinying Ma
Institutions
- Qingdao University (CN)
- Hebei Medical University (CN)
- Nanchang University (CN)
- Shanxi Medical University (CN)
- Capital Medical University (CN)
- Jilin University (CN)
- Anhui Medical University (CN)
- Peking University (CN)
- Shanghai Mental Health Center (CN)
- Third Hospital of Hebei Medical University (CN)
- Simcere Pharmaceutical (China) (CN)
- Nanfang Hospital (CN)
- Second Affiliated Hospital of Nanchang University (CN)
- Chinese Institute for Brain Research (CN)
- Ministry of Science and Technology (VN)
- Affiliated Hospital of Qingdao University (CN)
- Xianyang Normal University (CN)
- First Hospital of Jilin University (CN)
- Chengdu Second People's Hospital (CN)
- Second Hospital of Shanxi Medical University (CN)
- Xian Yang Central Hospital (CN)
- First Bethune Hospital of Jilin University (CN)
- Beijing HuiLongGuan Hospital (CN)
- Second Affiliated Hospital of Anhui Medical University (CN)
- Taian City Central Hospital (CN)
- Third People's Hospital of Hefei (CN)
- First Affiliated Hospital of Hebei Medical University (CN)
- First People's Hospital of Chongqing (CN)
- International Neuromodulation Society (US)
- Southern Medical University (CN)
- China Medical University (CN)
Publication Details
- Journal
- SLEEP
- Published
- 2025-06-24
- DOI
- https://doi.org/10.1093/sleep/zsaf170
- Citations
- 3
- Primary Topic
- Sleep and related disorders
- Type
- article
- Field-Weighted Citation Impact
- 6.35