Evidence map›Paper›PMID 35402894›Full record

ArticleSleep medicine: X2022

Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder.

Amitabh Dash, Kate Pinner, Yuichi Inoue, Kenichi Hayashida, Sung Chul Lim, Chang-Ho Yun, Tsuo-Hung Lan, Chieh-Liang Huang, Jane Yardley, Naoki Kubota and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Sleep medicine: X, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02952820 (A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02952820 phase3completednot on this map

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)

TypeinterventionalSponsorEisai Inc.Ran2016 to 2019Enrolled971ConditionsInsomnia DisorderArmslemborexant, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 5 countries.

Amitabh DashEisai Singapore Pte Ltd, 152 Beach Road, #15-05/08 Gateway East, 189721, Singapore.
Kate PinnerEisai Ltd., Mosquito Way, Hatfield AL10 9SN, UK.
Yuichi InoueTokyo Medical University, 6 Chome-1-1 Shinjuku, Shinjuku City, Tokyo 160-8402, Japan.
Kenichi HayashidaSleep Support Clinic, 1 Chome-18-8 Higashiōi, Shinagawa City, Tokyo 140-0011, Japan.
Sung Chul LimThe Catholic University of Korea, St. Vincent's Hospital, 93 Jungbu-daero, Ji-dong, Paldal-gu, Suwon, Gyeonggi-do, Republic of Korea.
Chang-Ho YunDepartment of Neurology, Bundang Clinical Neuroscience Institute, Seoul National University Bundang Hospital, 173 Gumi-ro, beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea.
Tsuo-Hung LanTsaotun Psychiatric Center, Ministry of Health and Welfare, 161 Yu-Pin Road, Tsaotun, Nantou 54249, Taiwan.
Chieh-Liang HuangTsaotun Psychiatric Center, Ministry of Health and Welfare, 161 Yu-Pin Road, Tsaotun, Nantou 54249, Taiwan.
Jane YardleyEisai Ltd., Mosquito Way, Hatfield AL10 9SN, UK.
Naoki KubotaEisai Co., Ltd, 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan.
Margaret MolineEisai Inc., 200 Metro Blvd, Nutley, NJ 07110, USA.
Eisai (United Kingdom) · GBEisai (Japan) · JPEisai (United States) · USMinistry of Health and Welfare · TWNational Yang Ming Chiao Tung University · TWSeoul National University Bundang Hospital · KRThe Catholic University of Korea St. Vincent's Hospital · KRTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Study objectives: Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303). Methods: Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Insomnia Severity Index (ISI), and Patient Global Impression-Insomnia version (PGI-I). Treatment-emergent adverse events (TEAEs) were assessed. Results: Overall, 178 Asian subjects (Japanese, Conclusions: LEM improved subjective sleep parameters and was well-tolerated in Asian subjects with insomnia disorder over 12 months. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.

Indexed as

Asian continental ancestry groupDual orexin receptor antagonistHypnotics and sedativesInsomnia disorderLemborexantTreatment efficacy

Identifiers

PMID35402894
PMCPMC8987601
OpenAlexW4220848193

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.