Insomnia
Conditions
Interventions
add-on group:NA
initial treatment:NA
Switch group:NA
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and comply with the study procedures and willing to provide written informed consent; 2. Aged 18–85 years (inclusive), male or female, as of the baseline visit; 3. Meeting the diagnostic criteria for insomnia disorder according to the International Classification of Sleep Disorders, Third Edition (ICSD-3); 4. Insomnia Severity Index (ISI) score > 7 at baseline; 5. Deemed suitable for treatment with and prescribed lemborexant by the treating outpatient physician.
Exclusion criteria
Exclusion criteria: 1. Cognitive impairment that, in the investigator’s judgment, precludes reliable completion of study assessments; 2. Presence of severe or unstable cardiovascular, respiratory, gastrointestinal, immunological, urological, endocrine, neurological, or other significant systemic diseases; 3. Meeting ICSD-3 diagnostic criteria for other psychiatric disorders (e.g. major depressive disorder, bipolar disorder, schizophrenia, anxiety disorders) and currently in an acute episode; 4. Current suicidal risk; 5. Current use of, or planned use during the study period, moderate or strong CYP3A4 inducers or inhibitors (see Appendix 1 for the list of prohibited medications); 6. Participation in any interventional drug or device clinical trial within 1 month prior to enrolment; 7. Known contraindication to, or hypersensitivity to, lemborexant; 8. Pregnant or breastfeeding women; 9. Any other medical or psychological condition that, in the investigator’s opinion, may increase study risk, interfere with protocol adherence, or compromise study completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ISI change at 4th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratios of three patterns applied;Baseline characteristics of patients;The proportion of patients achieving a =7-point reduction in ISI score from baseline after 4 weeks of treatment; and the proportion of patients rated as improved on the Clinical Global Impression–Improvement scale (CGI-I score of 1–2);Change from baseline in GAD-7 score after 4 weeks of treatment; and change from baseline in PHQ-9 score after 4 weeks of treatment;Change from baseline in Fatigue Severity Scale (FSS) score after 4 weeks of treatment;Dose reduction of benzodiazepines (BZDs) and non-benzodiazepine hypnotics (non-BZDs), expressed as diazepam-equivalent doses, and the rate of successful dose reduction or discontinuation of prior hypnotic medications in the switch group after 4 weeks of treatment;Treatment persistence with lemborexant over the 4-week treatment period and analysis of reasons for treatment discontinuation; | — |
Countries
China
Contacts
Public ContactWang Yuping
Xuanwu Hospital, Capital Medical University
Outcome results
None listed