Evidence map›Paper›PMID 39632341›Full record

Trial reportNeuropsychopharmacology reports2025

Efficacy and safety of lemborexant in subjects with insomnia disorder receiving medications for depression or anxiety symptoms.

Andrew Krystal, Pierre Blier, Larry Culpepper, Andrew A Nierenberg, Yoshikazu Takaesu, Naoki Kubota, Margaret Moline, Manoj Malhotra, Kate Pinner, Jane Yardley

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuropsychopharmacology reports, 2025. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Trial
  2. 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

10 authors.

Andrew KrystalUniversity of California, San Francisco, California, USA.ORCID https://orcid.org/0000-0002-6702-781X
Pierre BlierThe Royal Institute of Mental Health Research, Ottawa, Ontario, Canada.ORCID https://orcid.org/0000-0002-9196-0706
Larry CulpepperBoston University School of Medicine, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-7655-0477
Andrew A NierenbergDauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-2897-0458
Yoshikazu TakaesuDepartment of Neuropsychiatry, University of the Ryukyus, Okinawa, Japan.ORCID https://orcid.org/0000-0002-9169-3249
Naoki KubotaEisai Co., Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0002-1292-0897
Margaret MolineEisai Inc., Nutley, New Jersey, USA.ORCID https://orcid.org/0000-0003-0807-2167
Manoj MalhotraEisai Inc., Nutley, New Jersey, USA.ORCID https://orcid.org/0000-0002-4315-8284
Kate PinnerEisai Ltd., Hatfield, UK.ORCID https://orcid.org/0000-0002-3475-2708
Jane YardleyEisai Ltd., Hatfield, UK.ORCID https://orcid.org/0000-0001-8198-4328

Funding

Eisai Inc. N/A
6 · The paper itself

Abstract

aimIndividuals with insomnia frequently have comorbid depression or anxiety. This study sought to provide a preliminary indication of the effects of lemborexant (LEM) in subjects treated for mild depression/anxiety symptoms.

methodsE2006-G000-303 (NCT02952820; EudraCT 2015-001463-39; SUNRISE-2) was a 12-month, phase 3, randomized, placebo-controlled, double-blind study where subjects with insomnia disorder were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10) for 6 months. During the second 6 months (not reported), placebo-treated subjects were re-randomized to LEM5 or LEM10. In this post hoc analysis, changes from baseline (CFB) in subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Fatigue Severity Scale, and Insomnia Severity Index were evaluated in subjects treated with medications for symptoms of depression/anxiety (subpopulation).

resultsOf 949 randomized subjects, 61 treated with medications for symptoms of depression/anxiety were included. In the subpopulation, CFB comparing LEM with placebo were generally smaller than the overall population due to a larger placebo response in the subpopulation. However, the magnitudes of CFB within the active treatment groups for sSOL, sWASO, sTST, and sSE were similar between the subpopulation and the overall population. No new safety signals were observed in the subpopulation.

conclusionLEM treatment benefited subjects with insomnia treated with medications for depression/anxiety symptoms, with no new safety signals. A greater placebo response in the subpopulation than in the overall population decreased the drug versus placebo effect size for LEM, as has been reported for other insomnia medications.

Indexed as

AnxietySleep Initiation and Maintenance DisordersAdultAgedAnti-Anxiety AgentsAntidepressive AgentsDepressionDouble-Blind MethodFemaleHumansMaleMiddle AgedPyridinesPyrimidinesTreatment OutcomeAnti-Anxiety AgentsAntidepressive AgentslemborexantPyridinesPyrimidinesantidepressantanxiolyticdual orexin receptor antagonistinsomnia disorderlemborexant

Identifiers

PMID39632341
PMCPMC11666340

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.