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NCT07847021

A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia

Sponsor: Shanghai Mental Health Center

View on ClinicalTrials.gov

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

DRUG

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