A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia
ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Mental Health Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (aged ≥18 years) of either sex who agree to participate in the study.
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).
Disqualifiers
Participants who are unable to understand and complete the various scales and questionnaire assessments.
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).
Generalized Anxiety Disorder-7 (GAD-7) score ≥15.
Patient Health Questionnaire-9 (PHQ-9) score ≥ 20.
Trial population
Adults (aged ≥18 years) who agree to participate in the study and 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) , with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Daridorexant 50 mg
DrugDaridorexant 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Daridorexant Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) score
Change from baseline in the Insomnia Severity Index (ISI) score at week 4 of treatment. ISI total score ranges 0-28; higher scores represent more severe insomnia (worse outcome).
Time frame
4 WeekSecondary outcomes
1
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12 of treatment. The Insomnia Severity Index is a 7-item self-rated scale with total scores ranging from 0 to 28. Higher ISI scores indicate greater severity of insomnia (worse outcome).
Time frame
Weeks 8 and 122
Insomnia remission rate
Insomnia remission rate at Weeks 4, 8, and 12, defined as the proportion of patients with an ISI score \<8;
Time frame
Weeks 4, 8, and 123
Proportion of treatment responders
Proportion of treatment responders among patients with moderate-to-severe insomnia at Weeks 4, 8, and 12 (responder defined as a total ISI reduction of ≥6 points from baseline; moderate-to-severe insomnia defined as an ISI score ≥15);
Time frame
Weeks 4, 8, and 124
Change from baseline in sleep efficiency (SE)
Change from baseline in sleep efficiency (SE) at Weeks 4, 8, and 12 of treatment. Sleep efficiency is calculated as the percentage of time spent asleep relative to time in bed. SE ranges from 0% to 100%; higher values indicate better sleep.
Time frame
Weeks 4, 8, and 12Sponsors and contacts
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Source ClinicalTrials.gov
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