Evaluating the effects of lemborexant on insomnia in Chinese adults
Official title: A Prospective, Multi-center, 3-month, Observational Study to Evaluate the Effectiveness and Safety of Lemborexant in Chinese Patients With Insomnia in Real World Setting.
Run by Guangdong Provincial People's Hospital · NCT06225947 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a medication called lemborexant can help adults in China with insomnia sleep better and feel safer while using it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT06225947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with insomnia who meet specific severity criteria.
✕Probably not a fit
Patients with severe psychiatric disorders or those who cannot comply with the study requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effectiveness and safety of lemborexant in treating insomnia among adult patients in China. It is a prospective, open-label, single-arm, multicenter study lasting 12 weeks, where participants will be monitored through self-evaluation reports and safety assessments at baseline and during four follow-up visits. Eligible participants must have a diagnosis of insomnia according to DSM-5 criteria and an Insomnia Severity Index score greater than 10. The study will provide insights into the real-world application of lemborexant for insomnia management.
Why it matters
Potential benefit: If successful, this study could provide valuable data on the effectiveness of lemborexant for improving sleep quality in patients with insomnia.
How similar studies have gone: Other studies have shown promise in evaluating the effectiveness of lemborexant for insomnia, suggesting that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) and agreed to participate in the study, regardless of gender. * Diagnosed with insomnia according to DSM-5. * Insomnia Severity Index (ISI) score \>10. * Subjects who can guarantee at least 7 hours of bedtime. * Subjects signed informed consent forms after the prescription. Exclusion Criteria: * Beings unable to understand the questionnaire. * PHQ-9 scores ≥ 20. * GAD-7 scores ≥ 15. * Suicidal thoughts/behaviors in the past one month or history of suicide, etc. * Severe psychiatric disorder in the judgment of the investigator prevents completion of the trial. * History of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject. * According to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.). * Other conditions not considered appropriate for participation by clinicians.
Where it's running
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China Recruiting -
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China Recruiting -
Guangzhou United Family Hospital
Guangzhou, Guangdong, China Recruiting -
Nanfang Hospital
Guangzhou, Guangdong, China Recruiting -
Clifford Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Fujun Jia, MD — Guangdong Provincial People's Hospital
- Study coordinator: Xueli Li, Master
- Email: lixueli@gdph.org.cn
- Phone: 15876549787
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.