Study on the efficacy and safety of lemborexant in adult insomnia patients (with or without mild depressive and anxiety symptoms)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600120809

Enrollment

Unknown

Registered

2026-03-19

Start date

2026-03-19

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Insomnia:None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age and gender: Aged 18–70 years, with no gender restriction. 2. Diagnosis: Met the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 3. Symptom severity: Athens Insomnia Scale (AIS) score >=7. 4. Depressive and anxiety status: Mild or lower levels of depression and anxiety (Patient Health Questionnaire-9 [PHQ-9] score < 10; Generalized Anxiety Disorder-7 [GAD-7] score < 10). 5. Compliance: Able to cooperate with scale completion and follow-up visits throughout the study. 6. Informed consent: Provided written informed consent prior to study participation.

Exclusion criteria

Exclusion criteria: 1. Presence of significant suicide risk as determined by clinical assessment. 2. Presence of psychotic disorders or personality disorders that may impair the ability to evaluate the safety and efficacy of the study drug. 3. Insomnia associated with other sleep disorders, or any existing conditions that affect or may potentially affect sleep. 4. History of drug or alcohol abuse or dependence within the past 6 months, or positive urine drug screening at study enrollment. 5. Evidence of clinically unstable or uncontrolled severe medical conditions. 6. Diagnosis of narcolepsy, or reported narcolepsy-related symptoms requiring further confirmation. 7. Diagnosis of severe obstructive sleep apnea syndrome. 8. Patients with poor sleep hygiene who are unwilling to make relevant modifications. 9. Pregnant or lactating patients. 10. Other conditions deemed inappropriate for study participation by the investigator.

Design outcomes

Primary

Measure	Time frame
Athens Insomnia Scale;	—

Secondary

Measure	Time frame
Epworth Daytime Sleepiness Scale;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Patient Health Questionnaire;Generalized Anxiety Disorder Scale;	—

Countries

China

Contacts

Public ContactShiping Xie

The Affiliated Brain Hospital of Nanjing Medical University

xieshiping@njmu.edu.cn+86 138 5158 8810

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026