A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.

Official Title
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Multicenter, Post-marketing Observational (Non-interventional) Study to Evaluate the Safety of DAYVIGO Tablet in Patients With Insomnia.

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: Lemborexant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are treated with lemborexant Participants who provide consent for participation in the study Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation Exclusion Criteria: Participants who were enrolled in this study before obtaining informed consent of this study Participants who were participating in a clinical trial at the time of this study

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lemborexant<br>Participants with insomnia will initiate treatment with lemborexant 5 milligram (mg), tablet, orally as per the clinical judgment of the treating physician as part of routine clinical care. Dosage and administration of lemborexant tablet will be according to package insert and actual dosing and frequency will be decided by physician including dose escalation from initial dose of 5 mg up to 10 mg once daily. All participants will be observed prospectively for up to 24 weeks. | Drug: Lemborexant<br>* Lemborexant oral tablets.<br>* Other names: DAYVIGO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | The adverse events considered by the investigators to be related to treatment with lemborexant will be classified as ADRs. The incidence of somnolence, parasomnia symptoms (nightmare, abnormal dreams, exploding head syndrome etc.), narcoleptic symptoms (sleep paralysis, hypnagogic hallucination, hypnopompic hallucination and cataplexy etc.), and suicidal ideation/suicidal behavior (intentional overdose, self-injurious ideation, suicidal ideation etc.) will be determined. | Up to 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Response to Treatment | Response to treatment will be assessed by the impression of general improvement consisting of Improvement, No change, and Worsening. One of these ratings will be selected based on physician's impression according to participants' complaints of insomnia symptoms and will be recorded in Electronic Data Capture (EDC). | Up to 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E2006, Lemborexant, Insomnia, Non-interventional, Dayvigo