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InsomniaPhase 3SUNRISE 1NCT02783729

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

A Phase 3 study testing Lemborexant and Zolpidem tartrate in people with Insomnia, run by Eisai Inc. at 102 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Insomnia
What is being tested?
Lemborexant and Zolpidem tartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,006 participants
Where
102 sitesin 7 countries
Study dates
31 May 2016to 30 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male age 65 years or older or female age 55 years or older at the time of informed consent
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder, as follows:
  • Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep (Note that if the complaint is limited to difficulty initiating sleep, the participant is not eligible)
  • Frequency of complaint ≥ 3 times per week
  • Duration of complaint ≥ 3 months
  • Associated with complaint of daytime impairment
Show all 17Show fewer
  • History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
  • Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
  • Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and habitual waketime between 05:00 and 09:00
  • Insomnia Severity Index (ISI) score ≥ 13
  • Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
  • Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
  • Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
  • Objective (polysomnography [PSG]) evidence of insomnia as follows:
  • Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night < 45 minutes
  • Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  • Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study

Who cannot join

  • A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:
  • STOPBang score ≥5
  • International Restless Legs Scale score ≥16
  • Epworth Sleepiness Scale score >15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participant's Medical History)
  • Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
  • On the Munich Parasomnia Scale (MUPS), endorsed the item that corresponds to a history of sleep-eating or reports a history of sleep-related violent behavior, sleep-driving, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
Show all 31Show fewer
  • Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit
  • Beck Depression Inventory - II (BDI-II) score >19 at Screening
  • Beck Anxiety Index (BAI) score >15 at Screening
  • Habitually naps during the day more than 3 times per week
  • Is a female of childbearing potential Note: All females will be considered to be of childbearing potential unless they are postmenopausal (defined as amenorrheic for at least 12 consecutive months, and are postmenopausal without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
  • Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study.
  • History of drug or alcohol dependency or abuse within approximately the previous 2 years
  • Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study
  • Known to be positive for human immunodeficiency virus
  • Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  • A prolonged QT/QTcF interval (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms)
  • Current evidence of clinically significant disease (e.g., cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments, including the ability to perform tasks on the cognitive performance assessment battery (PAB). Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded.
  • Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
  • Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessment, including the ability to perform the PAB.
  • Any suicidal ideation with intent with or without a plan, at the time of or within 6 months before the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) administration during the Prerandomization Phase (i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the eC-SSRS)
  • Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
  • Scheduled for surgery during the study
  • Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half lives, whichever is longer, before the first dose of study medication (Run-in Period).
  • Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period)
  • Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
  • Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel across more than 3 time zones during the study
  • A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study
  • Hypersensitivity to lemborexant or zolpidem or to their excipients
  • Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5× the half-life, whichever is longer preceding informed consent
  • Previously participated in any clinical trial of lemborexant

Trial locations and contacts

102 sites in 7 countries.

102 sites in 7 countries

United States60 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • NeuroTrials Research Inc.

    Atlanta, Georgia, 30342

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Study site

    Carlsbad, California, 92011

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina, 29425

  • Helene A Emsellem MD PC

    Chevy Chase, Maryland, 20815

  • Northwestern University

    Chicago, Illinois, 60611

  • Chicago Research Center Inc

    Chicago, Illinois, 60634

  • Study site

    Cincinnati, Ohio, 45212

  • Intrepid Research

    Cincinnati, Ohio, 45245

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45255

  • Saint Francis Sleep Allergy and Lung Institute

    Clearwater, Florida, 33765

  • Sleepmed of South Carolina

    Columbia, South Carolina, 29201

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017

  • CLINiLABS, Inc.

    Eatontown, New Jersey, 07724

  • Fleming Island Center For Clinical Research

    Fleming Island, Florida, 32003

  • Southern California Research

    Fountain Valley, California, 92708

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Winthrop University Hospital

    Garden City, New York, 11530

  • Sleep Disorders Center of the Mid-Atlantic

    Glen Burnie, Maryland, 21061

  • PACT

    Glendale, Arizona, 85306

  • MD Clinical

    Hallandale, Florida, 33009

  • QPS MRA

    Hollywood, Florida, 33024

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • Jasper Summit Research LLC

    Jasper, Alabama, 35501

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)

    Miami, Florida, 33143

  • Cleveland Sleep Research Center

    Middleburg Heights, Ohio, 44130

  • Clinical Research Unit

    New York, New York, 10019

  • Neurocare Inc

    Newton, Massachusetts, 02459

  • Henry Ford Hospital

    Novi, Michigan, 48377

  • Research Centers of America

    Oakland Park, Florida

  • Pacific Sleep Medicine Services

    Oceanside, California, 92054

  • Research Center of Southern California

    Oceanside, California, 92056

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Orange County Neuropsychiatric Research Center, LLC

    Orange, California, 92868

  • SDS Clinical Trials, Inc.

    Orange, California, 92868

  • Compass Research LLC

    Orlando, Florida, 32806

  • NeuroMedical Research Institute

    Panama City, Florida, 32405

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-3309

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • University of Rochester

    Rochester, New York, 14642

  • Artemis Institute For Clinical Research LLC

    San Diego, California, 92103

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Artemis Institute For Clinical Research

    San Marcos, California, 92078

  • Santa Monica Clinical Trials

    Santa Monica, California, 90404

  • Study site

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98122

  • St. Louis Clinical Trials

    St Louis, Missouri, 63141

  • Clayton Sleep Institute

    St Louis, Missouri, 63143

  • Clinical Research Group of St Petersburg Inc

    St. Petersburg, Florida, 33707

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Clinical Neurophysiology Services

    Sterling Heights, Michigan, 48314

  • SleepCare Research Institute Inc

    Stockbridge, Georgia, 30281

  • Empire Clinical Research

    Upland, California, 91786

  • Sleep Disorders Center of the Mid-Atlantic

    Vienna, Virginia, 22182

  • Sleep Medicine Centers of Western New York

    West Seneca, New York, 14224

  • Wilmington Health Associates

    Wilmington, North Carolina, 28401

Other trials in United States

Spain10 sites

  • Hospital San Rafael

    A Coruña

  • Hospital Clinic de Barcelona

    Badalona

  • Study site

    Barcelona, 08025

  • Clinica del Son Estivill

    Barcelona

  • Hospital de La Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Instituto de Investigaciones del Sueño

    Madrid

  • Clinica Universidad de Navarra

    Pamplona, Navarre

  • Hospital Universitario Araba - Txagorritxu

    Vitoria-Gasteiz

Other trials in Spain

Canada8 sites

  • Sleep and Fatigue Institute

    Calgary, Alberta

  • Medical Arts Health Research Group

    Kelowna, British Columbia

  • Study site

    Markham, Ontario, L3R 1A3

  • Somni Research Inc.

    Markham, Ontario

  • Tri Hospital Sleep West

    Mississauga, Ontario

  • Sleep Wake Disorders Clinic

    Scarborough Village, Ontario

  • Study site

    Toronto, Ontario, M4P 1P2

  • Toronto Sleep Institute

    Toronto, Ontario

Other trials in Canada

Germany8 sites

  • Advanced Sleep Research GmbH

    Berlin

  • Emovis GmbH

    Berlin

  • Studienzentrum Wilhelmshöhe

    Kassel

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein

  • Zentralinstitut für Seelische Gesundheit

    Mannheim, Baden-Wurttemberg

  • Klinikum rechts der Isar der Technischen Universität München

    München

  • Universitätsklinikum Münster

    Münster

  • Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin

Other trials in Germany

Italy7 sites

  • Ospedale Bellaria

    Bologna, Emilia-Romagna

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

    Pavia

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

  • Fondazione PTV Policlinico Tor Vergata

    Roma

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino

Other trials in Italy

France5 sites

  • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

    Bordeaux

  • Hopital Gabriel Montpied

    Clermont-Ferrand

  • CHU Dijon Bourgogne

    Dijon

  • Hôtel Dieu de Paris Hospital

    Paris

  • Hopital Civil

    Strasbourg

Other trials in France

United Kingdom4 sites

  • Papworth Hospital

    Cambridge, Cambridge Shire

  • University of Surrey

    Guildford, Surrey

  • Guys Hospital

    London

  • Royal Stoke University Hospital

    Stoke-on-Trent

Other trials in United Kingdom

About this study

Official title: 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)

This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

Read the detailed description

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for 30 nights in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. Approximately 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

Conditions
Insomnia
Being tested
Lemborexant, Lemborexant-matched placebo, Zolpidem tartrate, Zolpidem-matched placebo
Keywords
E2006, Lemborexant, zolpidem tartrate, Ambien CR, Insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LemborexantDrug

    Also called E2006

    Lemborexant 5 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

  • LemborexantDrug

    Also called E2006

    Lemborexant 10 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

  • Lemborexant-matched placeboDrug

    Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

  • Zolpidem tartrateDrug

    Also called Ambien CR

    Zolpidem tartrate extended release 6.25 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

  • Zolpidem-matched placeboDrug

    Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.

Study groups in NCT02783729
Study groupRoleWhat they receive
Lemborexant 5 milligrams (mg)ExperimentalParticipants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
Receives: Drug: Lemborexant; Drug: Zolpidem-matched placebo
Lemborexant 10 mgExperimentalParticipants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
Receives: Drug: Lemborexant; Drug: Zolpidem-matched placebo
Zolpidem tartrateActive comparatorParticipants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
Receives: Drug: Lemborexant-matched placebo; Drug: Zolpidem tartrate
PlaceboPlacebo comparatorParticipants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
Receives: Drug: Lemborexant-matched placebo; Drug: Zolpidem-matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported.

    Measured: Baseline, Days 29/30

Secondary outcomes (3)

  1. Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30

    SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported.

    Measured: Baseline, Days 29/30

  2. Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30

    WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported.

    Measured: Baseline, Days 29/30

  3. Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30

    WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported.

    Measured: Baseline, Days 29/30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study start31 May 2016
  3. Primary completion30 Jan 2018
  4. Study completion30 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,006 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783729
Sponsor's protocol ID
E2006-G000-304
Other IDs
2015-004347-39, 2015
Acronym
SUNRISE 1
Status last verified
Mar 2018
First submitted
24 May 2016
Last updated
12 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Suzuki M, Yoshiike T, Khullar A, Kogo Y, Inabe K, Koebis M, Moline M, Cheng JY, Kumar D, Pinner K, Kuriyama K. Effects of lemborexant on sleep quality and its association with morning alertness: Post hoc analysis of two phase 3 trials. Sleep Med X. 2026 Mar 5;11:100183. doi: 10.1016/j.sleepx.2026.100183. eCollection 2026 Dec.

    PubMed 41938624

  • Kushida CA, Zammit GK, Cheng JY, Kumar D, Moline M. Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea. Sleep Med. 2025 Mar;127:170-177. doi: 10.1016/j.sleep.2024.12.023. Epub 2024 Dec 17.

    PubMed 39879708

  • Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9.

    PubMed 39120786

  • Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.

    PubMed 37796657

  • Inoue Y, Nishida M, Kubota N, Koebis M, Taninaga T, Muramoto K, Ishikawa K, Moline M. Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended-release for insomnia disorder subtypes defined based on polysomnographic findings. J Clin Sleep Med. 2023 Mar 1;19(3):519-528. doi: 10.5664/jcsm.10378.

    PubMed 36472134

  • 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.

    PubMed 35254948

  • 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.

    PubMed 34077032

  • Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150.

    PubMed 33590823

  • Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254.

    PubMed 31880796

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lemborexant and Zolpidem tartrate in people with Insomnia, run by Eisai Inc. at 102 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Spain, Canada, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783729, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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