Insomnia
Conditions
Keywords
daridorexant, insomnia, dual orexin receptor antagonist, real-world study
Brief 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.
Detailed description
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).
Interventions
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.
Sponsors
Shanghai Mental Health Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (aged ≥18 years) of either sex who agree to participate in the study. 2. 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: 1. Difficulty initiating sleep (sleep latency exceeding 30min in adults); 2. Difficulty maintaining sleep (≥2 nocturnal awakenings); 3. Early morning awakening, reduced sleep quality, and reduced total sleep time (usually \<6.5h). 3. Insomnia Severity Index (ISI) score \>7. 4. Ability to ensure at least 7 hours of time in bed. 5. Participants sign the informed consent form after the study drug prescription has been issued.
Exclusion criteria
1. Participants who are unable to understand and complete the various scales and questionnaire assessments. 2. 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). 3. Generalized Anxiety Disorder-7 (GAD-7) score ≥15. 4. Patient Health Questionnaire-9 (PHQ-9) score ≥ 20. 5. 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. 6. 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. 7. 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. 8. 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). 9. Any other condition that the clinician judges to render participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index (ISI) score | 4 Week | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12 | 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). |
| Insomnia remission rate | Weeks 4, 8, and 12 | Insomnia remission rate at Weeks 4, 8, and 12, defined as the proportion of patients with an ISI score \<8; |
| Proportion of treatment responders | Weeks 4, 8, and 12 | 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); |
| Change from baseline in sleep efficiency (SE) | Weeks 4, 8, and 12 | 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. |
| Change from baseline in the Epworth Sleepiness Scale (ESS) score | Weeks 4, 8, and 12 | 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). |
| Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score | Weeks 4, 8, and 12 | 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). |
| Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score | Week 16 | 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). |
| Change from baseline in the 36-Item Short-Form Health Survey (SF-36) | Week 12 | 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). |
| Change from baseline in the Insomnia Severity Index (ISI) score across the three treatment modalities | Weeks 4, 8, and 12 | 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). |
| Change in the pre-existing treatment regimen in the non-treatment-naïve group | Weeks 4, 8, and 12 | 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); |
| Daridorexant continuation rate and reasons for discontinuation | Weeks 4, 8, 12, and 16 | 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). |
Countries
China
Contacts
CONTACTWenzheng Wang
Outcome results
None listed