A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Eisai Clinical Trials

Protocol # E2006-G000-304

Study Overview

Study Compound: E2006

Drug Name: lemborexant

Registry #: NCT02783729, 2015-004347-39

Trial Period: May 2016 - Jan 2018

Indication: Insomnia

Primary Endpoint:
1. Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 [ Time Frame: Baseline, Days 29/30]

Population
Males and females 55 Years and Older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Canada, France, Germany, Italy, Spain, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

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.

Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82:20m13795. doi: 10.4088/JCP.20m13795.

Data Sharing

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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