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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
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This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.
This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ISI ≥10, clinically judged to need pharmacological treatment will be enrolled.Patients will be administered with LEM, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant(LEM) | Subjects will be administered with Lemborexant(LEM). The dosage of LEM is 5 mg or 10mg taken no more than once per night during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant 5 MG | Drug | The recommended dosage of Lemborexant(LEM) is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with insomnia remission | Percentage of patients with total ISI score below 8 points after Lemborexant treatment. Insomnia remission is defined as total ISI below 8points. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 1, week 2, week 4, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate of Lemborexant treatment at each visit | The retention rate is defined as the percentage of participants remaining on Lemborexant treatment regardless of treatment pattern, starting from the first dose of study drug. The retention is primarily defined as follows:
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients with insomnia administered with LEM.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueli Li, Master | Contact | 15876549787 | lixueli@gdph.org.cn | |
| Shuqiong Zheng, Master | Contact | 13192676969 | 844349307@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Fujun Jia, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Bin Zhang, MD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42226892 | Derived | Zheng S, Li X, Jian W, Tang Y, Lin Y, Jia F, Zhang B. Patient-Reported Outcomes for LEMborexant Treatment in Chinese Patients with Insomnia (PROEM): A Multicenter, Prospective, Real-World Observational Study. Nat Sci Sleep. 2026 May 27;18:596731. doi: 10.2147/NSS.S596731. eCollection 2026. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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| up to week 12 |
| Change from baseline of mean ISI score at each visit | Change of mean ISI score from baseline was defined as the average score of ISI scale at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 1, week 2, week 4, week 12 |
| Change from baseline of mean ISI score at LEM 5mg and 10 mg at each visit | Change of mean ISI score from baseline was defined as the average score of ISI scale at LEM 5mg and LEM 10mg at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 1, week 2, week 4, week 12 |
| Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit | Change of mean ISI score from baseline was defined as the average score of ISI scale at age <55 and ≥ 55 at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 1, week 2, week 4, week 12 |
| Change from baseline of mean ISI score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Change of mean ISI score from baseline was defined as the average score of ISI scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 1, week 2, week 4, week 12 |
| Change from baseline of mean ISI score in patients with depression symptoms at each visit | Change of mean ISI score from baseline was defined as the average score of ISI scale in patients with depression symptoms at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Proportion of insomnia treatment responders at each visit | Responder was defined as total ISI reduction≥6 compared to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. | Baseline, week 4, week 12 |
| Changes of mean ESS score at each visit | Change of mean ESS score from baseline was defined as the average score of ESS scale at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean ESS score at LEM 5mg and 10mg at each visit | Change of mean ESS score from baseline was defined as the average score of ESS scale at LEM 5mg and 10 mg at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean ESS score at age <55 and ≥ 55 at each visit | Change of mean ESS score from baseline was defined as the average score of ESS scale at age <55 and ≥ 55 at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean ESS score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Change of mean ESS score from baseline was defined as the average score of ESS scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean ESS score in patients with depression symptoms at each visit | Change of mean ESS score from baseline was defined as the average score of ESS scale in patients with depression symptoms at each visit relative to baseline. The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean QOL-BREF score at each visit | Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. | Baseline, week 4, week 12 |
| Changes of mean QOL-BREF score at LEM 5mg and 10mg at each visit | Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at LEM 5mg and 10mg at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. | Baseline, week 4, week 12 |
| Changes of mean QOL-BREF score at age <55 and ≥ 55 at each visit | Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at age <55 and ≥ 55 at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. | Baseline, week 4, week 12 |
| Changes of mean QOL-BREF score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. | Baseline, week 4, week 12 |
| Changes of mean QOL-BREF score in patients with depression symptoms at each visit | Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale in patients with depression symptoms at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 4, week 12 |
| Changes of mean PHQ-9 score at each visit | Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean PHQ-9 score at LEM 5mg and 10mg at each visit | Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at LEM 5mg and 10mg at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean PHQ-9 score at age <55 and ≥ 55 at each visit | Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at age <55 and ≥ 55 at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean PHQ-9 score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean PHQ-9 score in patients with depression symptoms at each visit | Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale in patients with depression symptoms at each visit relative to baseline. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10.The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean GAD-7 score at each visit | Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean GAD-7 score at LEM 5mg and 10mg at each visit | Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at LEM 5mg and 10mg at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean GAD-7 score at age <55 and ≥ 55 at each visit | Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at age <55 and ≥ 55 at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean GAD-7 score with LEM monotherapy, alternative therapy, and combination therapy at each visit | Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. | Baseline, week 1, week 2, week 4, week 12 |
| Changes of mean GAD-7 score in patients with depression symptoms at each visit | Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale in patients with depression symptoms at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression. | Baseline, week 1, week 2, week 4, week 12 |
| Incidence of Treatment-Emergent Adverse Events during LEM treatment | Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity | Up to week 12 |
| Incidence of Serious Adverse Events during LEM treatment | Percentage of Participants Reporting one or More Serious Adverse Events (SAEs) | Up to week 12 |
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Guangzhou United Family Hospital | Recruiting | Guangzhou | Guangdong | 510335 | China |
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| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Clifford Hospital | Recruiting | Guangzhou | Guangdong | 511400 | China |
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| D001523 |
| Mental Disorders |