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

NCT02783729 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: E2006-G000-3042015-004347-39
• Study Type: interventional
• Target: 1,006
• Locations: 7 countries
• Sites: 102

Brief 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.

Conditions

Insomnia

Keywords

E2006; Lemborexant; zolpidem tartrate; Ambien CR; Insomnia

Outcome Measures

Primary Outcomes (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.

  Baseline, Days 29/30

Secondary Outcomes (3)

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

  Baseline, Days 29/30

• 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

  Baseline, Days 29/30

• 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

  Baseline, Days 29/30

Other Outcomes (14)

• Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3

  Baseline, Days 2/3

• Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30

  Baseline, Days 1/2, and Days 29/30

• Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER

  First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)

Study Arms (4)

Lemborexant 5 milligrams (mg)

EXPERIMENTAL

Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night

Drug: Lemborexant; Drug: Zolpidem-matched placebo

Lemborexant 10 mg

EXPERIMENTAL

Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night

Drug: Lemborexant; Drug: Zolpidem-matched placebo

Zolpidem tartrate

ACTIVE COMPARATOR

Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night

Drug: Lemborexant-matched placebo; Drug: Zolpidem tartrate

Placebo

PLACEBO COMPARATOR

Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night

Drug: Lemborexant-matched placebo; Drug: Zolpidem-matched placebo

Interventions

Lemborexant DRUG

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.

Also known as: E2006

Lemborexant 5 milligrams (mg)

Lemborexant-matched placebo DRUG

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

Placebo; Zolpidem tartrate

Zolpidem tartrate DRUG

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.

Also known as: Ambien CR

Zolpidem tartrate

Zolpidem-matched placebo DRUG

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; Lemborexant 5 milligrams (mg); Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• a) Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night \< 45 minutes

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (102)

Jasper Summit Research LLC

Jasper, Alabama, 35501, United States

Location

PACT

Glendale, Arizona, 85306, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Unknown Facility

Carlsbad, California, 92011, United States

Location

Southern California Research

Fountain Valley, California, 92708, United States

Location

Pacific Sleep Medicine Services

Oceanside, California, 92054, United States

Location

Research Center of Southern California

Oceanside, California, 92056, United States

Location

Orange County Neuropsychiatric Research Center, LLC

Orange, California, 92868, United States

Location

SDS Clinical Trials, Inc.

Orange, California, 92868, United States

Location

Artemis Institute For Clinical Research LLC

San Diego, California, 92103, United States

Location

Pacific Research Network Inc

San Diego, California, 92103, United States

Location

Artemis Institute For Clinical Research

San Marcos, California, 92078, United States

Location

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Saint Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765, United States

Location

Fleming Island Center For Clinical Research

Fleming Island, Florida, 32003, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

QPS MRA

Hollywood, Florida, 33024, United States

Location

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

Miami, Florida, 33143, United States

Location

Research Centers of America

Oakland Park, Florida, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

NeuroMedical Research Institute

Panama City, Florida, 32405, United States

Location

Clinical Research Group of St Petersburg Inc

St. Petersburg, Florida, 33707, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

SleepCare Research Institute Inc

Stockbridge, Georgia, 30281, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Chicago Research Center Inc

Chicago, Illinois, 60634, United States

Location

Helene A Emsellem MD PC

Chevy Chase, Maryland, 20815, United States

Location

Sleep Disorders Center of the Mid-Atlantic

Glen Burnie, Maryland, 21061, United States

Location

Neurocare Inc

Newton, Massachusetts, 02459, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Novi, Michigan, 48377, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

CLINiLABS, Inc.

Eatontown, New Jersey, 07724, United States

Location

Winthrop University Hospital

Garden City, New York, 11530, United States

Location

Clinical Research Unit

New York, New York, 10019, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Sleep Medicine Centers of Western New York

West Seneca, New York, 14224, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Wilmington Health Associates

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Cincinnati, Ohio, 45212, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45255, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Cleveland Sleep Research Center

Middleburg Heights, Ohio, 44130, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425, United States

Location

Sleepmed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Pioneer Research Solutions

Houston, Texas, 77099, United States

Location

Sleep Disorders Center of the Mid-Atlantic

Vienna, Virginia, 22182, United States

Location

Unknown Facility

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Sleep and Fatigue Institute

Calgary, Alberta, Canada

Location

Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Location

Unknown Facility

Markham, Ontario, L3R 1A3, Canada

Location

Somni Research Inc.

Markham, Ontario, Canada

Location

Tri Hospital Sleep West

Mississauga, Ontario, Canada

Location

Sleep Wake Disorders Clinic

Scarborough Village, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, M4P 1P2, Canada

Location

Toronto Sleep Institute

Toronto, Ontario, Canada

Location

Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Bordeaux, France

Location

Hopital Gabriel Montpied

Clermont-Ferrand, France

Location

CHU Dijon Bourgogne

Dijon, France

Location

Hôtel Dieu de Paris Hospital

Paris, France

Location

Hopital Civil

Strasbourg, France

Location

Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Location

Advanced Sleep Research GmbH

Berlin, Germany

Location

Emovis GmbH

Berlin, Germany

Location

Studienzentrum Wilhelmshöhe

Kassel, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, Germany

Location

Ospedale Bellaria

Bologna, Emilia-Romagna, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Location

ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, Italy

Location

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Location

Hospital San Rafael

A Coruña, Spain

Location

Hospital Clinic de Barcelona

Badalona, Spain

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Clinica del Son Estivill

Barcelona, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Instituto de Investigaciones del Sueño

Madrid, Spain

Location

Hospital Universitario Araba - Txagorritxu

Vitoria-Gasteiz, Spain

Location

Papworth Hospital

Cambridge, Cambridge Shire, United Kingdom

Location

University of Surrey

Guildford, Surrey, United Kingdom

Location

Guys Hospital

London, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 39879708 DERIVED

• 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.

  PMID: 39120786 DERIVED

• 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.

  PMID: 37796657 DERIVED

• 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.

  PMID: 36472134 DERIVED

• 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.

  PMID: 35254948 DERIVED

• 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.

  PMID: 34077032 DERIVED

• 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.

  PMID: 33590823 DERIVED

• 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.

  PMID: 31880796 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

1-888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: May 31, 2016
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: November 12, 2024
• Results First Posted: February 11, 2020

Record last verified: 2018-03

Locations

ES (10); GB (4); FR (5); US (60); DE (8); CA (8); IT (7)