A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)

Eisai Clinical Trials

Protocol # E2006-G000-303

Study Overview

Study Compound: E2006

Drug Name: lemborexant

Registry #: NCT02952820, 2015-001463-39

Trial Period: Nov 2016 - Jan 2019

Indication: Insomnia Disorder

Primary Endpoint:
1. Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 [ Time Frame: Baseline and Month 6]

Population
Males and females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Canada, Finland, Germany, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Romania, Spain, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Dash A, Pinner K, Inoue Y, Hayashida K, Lim SC, Yun CH, Lan TH, Huang CL, Yardley J, Kubota N, Moline M. Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder. Sleep Med X. 2022 Mar 24;4:100044. doi: 10.1016/j.sleepx.2022.100044. eCollection 2022 Dec.

Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR