A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia

Ki vehet részt

• 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

Ki nem vehet részt

• 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