An observational study in Sleep Initiation and Maintenance Disorders, sponsored by Eisai Co., Ltd.. Completed at 3 sites in Japan. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Eisai Co., Ltd. · Observational
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 550 is above the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 300 participants with insomnia
Exclusion Criteria:
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
Lemborexant oral tablets.
Also known as: E2006, DAYVIGO
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.
Time frame: Up to 24 Weeks
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).
Time frame: Up to 24 Weeks
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Eisai Co., Ltd.