An observational study in Insomnia, sponsored by Shanghai Mental Health Center. Not yet recruiting at 25 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Shanghai Mental Health Center · Observational
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.
Background: Insomnia is a highly prevalent sleep disorder that markedly impairs quality of life, with the prevalence of insomnia symptoms ranging from 30% to 48%. Long-term use of benzodiazepines may result in daytime sleepiness, cognitive impairment, tolerance, and risk of dependence, and has even been associated with early-onset dementia; daridorexant avoids many of the adverse effects associated with conventional hypnotic agents. Daridorexant was approved for marketing in China in June 2025; however, large-sample real-world studies of daridorexant are currently lacking. Hypothesis: Daridorexant administered for 16 weeks significantly improves symptoms in patients with insomnia, with a favorable safety profile. Design: A multicenter, prospective, single-arm, observational study with a planned enrollment of 500 patients (assuming an estimated dropout rate of 15%). Patients will receive treatment for 16 weeks, and outcomes will be assessed as the change from baseline in the Insomnia Severity Index (ISI), in sleep parameters (sleep efficiency [SE] and total sleep time [TST]), in the Epworth Sleepiness Scale (ESS) score, in the Clinical Global Impression-Improvement (CGI-I) scale, in the Patient Global Impression-Improvement (PGI-I) scale, and in the 36-Item Short-Form Health Survey (SF-36).
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:
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:
Exclusion Criteria:
All enrolled patients receive daridorexant treatment for a 16-week study period.
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.
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 Week
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 12
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 12
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 12
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 12
Change from baseline in the Epworth Sleepiness Scale (ESS) score
Change from baseline in the Epworth Sleepiness Scale (ESS) score at Weeks 4, 8, and 12. ESS total score ranges 0-24; higher scores represent more severe daytime sleepiness (worse outcome).
Time frame: Weeks 4, 8, and 12
Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score
Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score at Weeks 4, 8, and 12 of treatment. The CGI-I is a 7-point clinician-rated scale ranging from 1 to 7. Lower scores indicate greater clinical improvement (better outcome).
Time frame: Weeks 4, 8, and 12
Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score
Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score at Week 16 of treatment. The PGI-I is a 7-point patient-rated scale ranging from 1 to 7. Lower scores indicate greater patient-perceived clinical improvement (better outcome).
Time frame: Week 16
Change from baseline in the 36-Item Short-Form Health Survey (SF-36)
Change from baseline in the 36-Item Short-Form Health Survey (SF-36) score at Week 12 of treatment. The SF-36 is a self-reported health questionnaire comprising 8 domains. Domain and summary scores range from 0 to 100. Higher scores indicate better health-related quality of life (better outcome).
Time frame: Week 12
Change from baseline in the Insomnia Severity Index (ISI) score across the three treatment modalities
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 4, 8, and 12 of treatment, compared across three treatment modalities (treatment-naïve therapy, switch therapy, and add-on therapy). 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 4, 8, and 12
Change in the pre-existing treatment regimen in the non-treatment-naïve group
Change in the pre-existing treatment regimen in the non-treatment-naïve group at Weeks 4, 8, and 12 (success rate of dose reduction or discontinuation of prior medications);
Time frame: Weeks 4, 8, and 12
Daridorexant continuation rate and reasons for discontinuation
Daridorexant continuation rate and reasons for discontinuation at Weeks 4, 8, 12, and 16 (continuation rate defined as the percentage of participants who remain on daridorexant treatment, irrespective of treatment modality).
Time frame: Weeks 4, 8, 12, and 16
Plan to share: No
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Sleep Initiation and Maintenance Disorders→
Shanghai Mental Health Center