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A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia
Sponsor: Shanghai Mental Health Center
Summary
This study aims to evaluate the effectiveness and safety of daridorexant, a novel dual orexin receptor antagonist (DORA), in patients with insomnia. The study population consists of patients aged 18 years and older who present with core insomnia symptoms as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition); eligible patients will receive daridorexant for 16 weeks and will be followed up for improvement in insomnia symptoms and for the occurrence of adverse events, so as to provide real-world evidence to inform the optimization of clinical treatment strategies for insomnia.
Official title: Real-World Efficacy and Safety of Daridorexant in Chinese Patients With Insomnia (DREAM-Real): A Multicenter, Prospective Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-10-01
Completion Date
2028-07-31
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Daridorexant 50 mg
Daridorexant hydrochloride tablets (50mg, 20 tablets/box; distributor: Jiangsu Simcere Pharmaceutical Co., Ltd.; store at no more than 30°C). Administered orally: daridorexant 50mg, taken no more than once per night immediately before bedtime, with at least 7 hours remaining before the planned time of awakening.
Locations (25)
Chaohu Hospital of Anhui Medical University
Chaohu, Anhui, China
The Second People's Hospital of Hefei
Hefei, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Fuzhou Second General Hospital Neuropsychiatric Prevention and Treatment Hospital
Fuzhou, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The Fourth People's Hospital of Shantou
Shantou, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Harbin First Specialized Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Mental Health Center
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Suzhou Guangji Hospital
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Shanghai Putuo District People's Hospital
Shanghai, Shanghai Municipality, China
Taiyuan Psychiatric Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China