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

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai trial site 1, Nagoya, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemborexant

Drug

Lemborexant oral tablets.

Other names: E2006, DAYVIGO

Primary outcomes

Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

Time frame: 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 outcomes

Number of Participants With Response to Treatment

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 5, 2020
Registry last updated: Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed