A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia

Trial details

Who runs it

Shanghai Mental Health Center

Trial code

NCT07847021

Record updated

29 September 2026

Original description

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.Read full original descriptionShow less

Real-World Efficacy and Safety of Daridorexant in Chinese Patients With Insomnia (DREAM-Real): A Multicenter, Prospective Observational Study

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.

Inclusion: Adults (aged ≥18 years) of either sex who agree to participate in the study; Core insomnia symptoms documented by the physician during routine clinical care, as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition) (meeting at least one of the following criteria), with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:; Difficulty initiating sleep (sleep latency exceeding 30min in adults); Difficulty maintaining sleep (≥2 nocturnal awakenings); Early morning awakening, reduced sleep quality, and reduced total sleep time (usually <6.5h); Insomnia Severity Index (ISI) score >7; Ability to ensure at least 7 hours of time in bed; Participants sign the informed consent form after the study drug prescription has been issued.

Exclusion: Patients whose insomnia symptoms have shown no significant improvement after standardized treatment with two or more concomitant hypnotic agents (including benzodiazepines, non-benzodiazepine hypnotics, orexin receptor antagonists, and sedating antidepressants/antipsychotics); A history of serious illness, concomitant medication use, cognitive impairment, or uncontrolled poor sleep habits that, in the investigator's judgment, would interfere with study assessments or participant safety; Generalized Anxiety Disorder-7 (GAD-7) score ≥15; Patients who answer "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS), or who have a history of suicide attempt in the suicidal behavior section; Patients with severe mental disorders (including but not limited to schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar disorder, mental disorder due to epilepsy, and intellectual developmental disorder with comorbid mental disorder) who are currently in an acute episode or whose condition is unstable, and who, in the investigator's judgment, may compromise trial adherence, be unable to complete the full follow-up, or present a significant safety risk; Any contraindication or other condition precluding use as specified in the precautions of the package insert (e.g., hypersensitivity to daridorexant or to any of the excipients, narcolepsy, severe hepatic impairment, pregnancy, or lactation); Any other condition that the clinician judges to render participation inappropriate; Participants who are unable to understand and complete the various scales and questionnaire assessments; Patient Health Questionnaire-9 (PHQ-9) score ≥ 20.

ClinicalTrials.gov NCT07847021