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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04573556

Enrollment

550

Registered

2020-10-05

Start date

2020-10-17

Completion date

2022-03-17

Last updated

2022-04-05

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

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

E2006, Lemborexant, Insomnia, Non-interventional, Dayvigo

Brief summary

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.

Interventions

DRUGLemborexant

Lemborexant oral tablets.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 100 Years

Healthy volunteers

Inclusion criteria

1. Participants who are treated with lemborexant 2. Participants who provide consent for participation in the study 3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation

Exclusion criteria

1. Participants who were enrolled in this study before obtaining informed consent of this study 2. Participants who were participating in a clinical trial at the time of this study

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	Up to 24 Weeks	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.

Secondary

Measure	Time frame	Description
Number of Participants With Response to Treatment	Up to 24 Weeks	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).

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026