Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
- Conditions
- Insomnia
- Interventions
- Drug: Lemborexant-matched placeboDrug: Zolpidem-matched placebo
- Registration Number
- NCT02783729
- Lead Sponsor
- Eisai Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1006
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lemborexant 10 mg Zolpidem-matched placebo Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night Lemborexant 5 milligrams (mg) Zolpidem-matched placebo Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night Zolpidem tartrate Zolpidem tartrate Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night Placebo Zolpidem-matched placebo Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night Lemborexant 10 mg Lemborexant Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night Lemborexant 5 milligrams (mg) Lemborexant Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night Zolpidem tartrate Lemborexant-matched placebo Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night Placebo Lemborexant-matched placebo Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
- Primary Outcome Measures
Name Time Method 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 Baseline, 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
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 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.
Trial Locations
- Locations (95)
Saint Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
Toronto Sleep Institute
🇨🇦Toronto, Ontario, Canada
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Somni Research Inc.
🇨🇦Markham, Ontario, Canada
Northwestern University
🇺🇸Chicago, Illinois, United States
Chicago Research Center Inc
🇺🇸Chicago, Illinois, United States
NeuroTrials Research Inc.
🇺🇸Atlanta, Georgia, United States
PACT
🇺🇸Glendale, Arizona, United States
Clinical Research Unit
🇺🇸New York, New York, United States
Research Center of Southern California
🇺🇸Oceanside, California, United States
CLINiLABS, Inc.
🇺🇸Eatontown, New Jersey, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Clinical Research Group of St Petersburg Inc
🇺🇸Saint Petersburg, Florida, United States
Southern California Research
🇺🇸Fountain Valley, California, United States
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
SDS Clinical Trials, Inc.
🇺🇸Orange, California, United States
Fleming Island Center For Clinical Research
🇺🇸Fleming Island, Florida, United States
Sleep Disorders Center of the Mid-Atlantic
🇺🇸Vienna, Virginia, United States
Henry Ford Hospital
🇺🇸Novi, Michigan, United States
Jasper Summit Research LLC
🇺🇸Jasper, Alabama, United States
Pacific Sleep Medicine Services
🇺🇸Oceanside, California, United States
Orange County Neuropsychiatric Research Center, LLC
🇺🇸Orange, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
SleepCare Research Institute Inc
🇺🇸Stockbridge, Georgia, United States
Helene A Emsellem MD PC
🇺🇸Chevy Chase, Maryland, United States
Universitätsklinikum Münster
🇩🇪Münster, Germany
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Artemis Institute For Clinical Research
🇺🇸San Marcos, California, United States
Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
CHU Dijon Bourgogne
🇫🇷Dijon Cedex, France
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Advanced Sleep Research GmbH
🇩🇪Berlin, Germany
Emovis GmbH
🇩🇪Berlin, Germany
Guys Hospital
🇬🇧London, United Kingdom
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milan, Lombardia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Sleepmed of South Carolina
🇺🇸Columbia, South Carolina, United States
Hopital Gabriel Montpied
🇫🇷Clermont-ferrand, France
Hospital Universitario Araba - Txagorritxu
🇪🇸Vitória, Spain
St. Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Clinica del Son Estivill
🇪🇸Barcelona, Spain
Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪Schwerin, Germany
Sleep Medicine Centers of Western New York
🇺🇸West Seneca, New York, United States
Tri Hospital Sleep West
🇨🇦Mississauga, Ontario, Canada
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
🇮🇹Pavia, Italy
Studienzentrum Wilhelmshöhe
🇩🇪Kassel, Germany
University of Rochester
🇺🇸Rochester, New York, United States
Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Cleveland Sleep Research Center
🇺🇸Middleburg Heights, Ohio, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Hôtel Dieu de Paris Hospital
🇫🇷Paris, France
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Zentralinstitut für Seelische Gesundheit
🇩🇪Mannheim, Baden-Württemberg, Germany
Instituto de Investigaciones del Sueño
🇪🇸Madrid, Spain
Royal Stoke University Hospital
🇬🇧Stoke on Trent, United Kingdom
Hospital San Rafael
🇪🇸La Coruña, Spain
Papworth Hospital
🇬🇧Cambridge, Cambridge Shire, United Kingdom
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Italy
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
🇫🇷Bordeaux, France
Artemis Institute For Clinical Research LLC
🇺🇸San Diego, California, United States
Pacific Research Network Inc
🇺🇸San Diego, California, United States
Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)
🇺🇸Miami, Florida, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Empire Clinical Research
🇺🇸Upland, California, United States
QPS MRA
🇺🇸Hollywood, Florida, United States
Hospital Clinic de Barcelona
🇪🇸Badalona, Spain
Hopital Civil
🇫🇷Strasbourg, France
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Research Centers of America
🇺🇸Oakland Park, Florida, United States
NeuroMedical Research Institute
🇺🇸Panama City, Florida, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina - PPDS
🇺🇸Charleston, South Carolina, United States
Sleep and Fatigue Institute
🇨🇦Calgary, Alberta, Canada
Sleep Wake Disorders Clinic
🇨🇦Scarborough, Ontario, Canada
Neurocare Inc
🇺🇸Newton, Massachusetts, United States
Winthrop University Hospital
🇺🇸Garden City, New York, United States
Wilmington Health Associates
🇺🇸Wilmington, North Carolina, United States
University of Surrey
🇬🇧Guildford, Surrey, United Kingdom