Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
NCT ID: NCT02783729
Last Updated: 2024-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1006 participants
INTERVENTIONAL
2016-05-31
2018-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lemborexant 5 milligrams (mg)
Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
Lemborexant
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.
Zolpidem-matched placebo
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.
Lemborexant 10 mg
Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
Lemborexant
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.
Zolpidem-matched placebo
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.
Zolpidem tartrate
Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
Lemborexant-matched placebo
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 tartrate
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.
Placebo
Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
Lemborexant-matched placebo
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-matched placebo
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.
Interventions
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Lemborexant
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.
Lemborexant
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 placebo
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 tartrate
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 placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
4. Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
5. 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
6. Insomnia Severity Index (ISI) score ≥ 13
7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
8. Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
9. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
10. Objective (polysomnography \[PSG\]) evidence of insomnia as follows:
a) Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night \< 45 minutes
11. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
12. Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study
Exclusion Criteria
1. STOPBang score ≥5
2. International Restless Legs Scale score ≥16
3. Epworth Sleepiness Scale score \>15 (scores of 11 to 15 require excessive daytime sleepiness to be recorded in participant's Medical History)
2. 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
3. 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
4. Apnea-Hypopnea Index \> 15 or Periodic Limb Movement with Arousal Index \>15 as measured on the PSG at the second screening visit
5. Beck Depression Inventory - II (BDI-II) score \>19 at Screening
6. Beck Anxiety Index (BAI) score \>15 at Screening
7. Habitually naps during the day more than 3 times per week
8. 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).
9. 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.
10. History of drug or alcohol dependency or abuse within approximately the previous 2 years
11. 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
12. Known to be positive for human immunodeficiency virus
13. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
14. 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)
15. 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.
16. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
17. 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.
18. 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)
19. Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
20. Scheduled for surgery during the study
21. 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).
22. 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)
23. 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
24. 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
25. A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study
26. Hypersensitivity to lemborexant or zolpidem or to their excipients
27. 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
28. Previously participated in any clinical trial of lemborexant
55 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Jasper Summit Research LLC
Jasper, Alabama, United States
PACT
Glendale, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Carlsbad, California, United States
Southern California Research
Fountain Valley, California, United States
Pacific Sleep Medicine Services
Oceanside, California, United States
Research Center of Southern California
Oceanside, California, United States
Orange County Neuropsychiatric Research Center, LLC
Orange, California, United States
SDS Clinical Trials, Inc.
Orange, California, United States
Artemis Institute For Clinical Research LLC
San Diego, California, United States
Pacific Research Network Inc
San Diego, California, United States
Artemis Institute For Clinical Research
San Marcos, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Empire Clinical Research
Upland, California, United States
PAB Clinical Research
Brandon, Florida, United States
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States
Fleming Island Center For Clinical Research
Fleming Island, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
MD Clinical
Hallandale, Florida, United States
QPS MRA
Hollywood, Florida, United States
Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)
Miami, Florida, United States
Research Centers of America
Oakland Park, Florida, United States
Compass Research LLC
Orlando, Florida, United States
NeuroMedical Research Institute
Panama City, Florida, United States
Clinical Research Group of St Petersburg Inc
St. Petersburg, Florida, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
SleepCare Research Institute Inc
Stockbridge, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Chicago Research Center Inc
Chicago, Illinois, United States
Helene A Emsellem MD PC
Chevy Chase, Maryland, United States
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, United States
Neurocare Inc
Newton, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Novi, Michigan, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
CLINiLABS, Inc.
Eatontown, New Jersey, United States
Winthrop University Hospital
Garden City, New York, United States
Clinical Research Unit
New York, New York, United States
University of Rochester
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Sleep Medicine Centers of Western New York
West Seneca, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Wilmington Health Associates
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina - PPDS
Charleston, South Carolina, United States
Sleepmed of South Carolina
Columbia, South Carolina, United States
Pioneer Research Solutions
Houston, Texas, United States
Sleep Disorders Center of the Mid-Atlantic
Vienna, Virginia, United States
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Sleep and Fatigue Institute
Calgary, Alberta, Canada
Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Markham, Ontario, Canada
Somni Research Inc.
Markham, Ontario, Canada
Tri Hospital Sleep West
Mississauga, Ontario, Canada
Sleep Wake Disorders Clinic
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto Sleep Institute
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
Bordeaux, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
CHU Dijon Bourgogne
Dijon, , France
Hôtel Dieu de Paris Hospital
Paris, , France
Hopital Civil
Strasbourg, , France
Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Advanced Sleep Research GmbH
Berlin, , Germany
Emovis GmbH
Berlin, , Germany
Studienzentrum Wilhelmshöhe
Kassel, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, , Germany
Ospedale Bellaria
Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital San Rafael
A Coruña, , Spain
Hospital Clinic de Barcelona
Badalona, , Spain
Barcelona, , Spain
Clinica del Son Estivill
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Instituto de Investigaciones del Sueño
Madrid, , Spain
Hospital Universitario Araba - Txagorritxu
Vitoria-Gasteiz, , Spain
Papworth Hospital
Cambridge, Cambridge Shire, United Kingdom
University of Surrey
Guildford, Surrey, United Kingdom
Guys Hospital
London, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004347-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2006-G000-304
Identifier Type: -
Identifier Source: org_study_id
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