University of Oulu

Mikko Kärppä, Jane Yardley, Kate Pinner, Gleb Filippov, Gary Zammit, Margaret Moline, Carlos Perdomo, Yuichi Inoue, Kohei Ishikawa, Naoki Kubota, Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2, Sleep, Volume 43, Issue 9, September 2020, zsaa123, https://doi.org/10.1093/sleep/zsaa123

Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder : results from the phase 3 randomized clinical trial SUNRISE 2

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Author: Kärppä, Mikko1; Yardley, Jane2; Pinner, Kate2;
Organizations: 1Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland
2Eisai Co., Ltd., Hatfield, UK
3Eisai Inc., Woodcliff Lake, NJ
4Clinilabs Drug Development Corporation, New York, NY
5Tokyo Medical University, Tokyo, Japan
6Eisai Co., Ltd., Tokyo, Japan
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.4 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe202101202246
Language: English
Published: Oxford University Press, 2020
Publish Date: 2021-01-20
Description:

Abstract

Study Objectives: To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder.

Methods: This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.

Results: Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths.

Conclusions: LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.

Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39

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Series: Sleep
ISSN: 0161-8105
ISSN-E: 1550-9109
ISSN-L: 0161-8105
Volume: 43
Issue: 9
Pages: 1 - 11
DOI: 10.1093/sleep/zsaa123
OADOI: https://oadoi.org/10.1093/sleep/zsaa123
Type of Publication: A1 Journal article – refereed
Field of Science: 3112 Neurosciences
317 Pharmacy
Subjects:
Funding: This study was financially supported by Eisai Inc., Woodcliff Lake, NJ. Eisai Inc. is the owner and manufacturer of lemborexant.
Copyright information: © Sleep Research Society 2020. Published by Oxford University Press [on behalf of the Sleep Research Society]. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
  https://creativecommons.org/licenses/by-nd/4.0/