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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,006

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

January 30, 2018

Study Completion Date

January 30, 2018

Conditions
Insomnia
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (102)

10019

Clinical Research Unit, New York

10312

Richmond Behavioral Associates, Staten Island

11530

Winthrop University Hospital, Garden City

14224

Sleep Medicine Centers of Western New York, West Seneca

14642

University of Rochester, Rochester

20815

Helene A Emsellem MD PC, Chevy Chase

21061

Sleep Disorders Center of the Mid-Atlantic, Glen Burnie

22182

Sleep Disorders Center of the Mid-Atlantic, Vienna

27612

Wake Research Associates, LLC, Raleigh

28401

Wilmington Health Associates, Wilmington

29201

Sleepmed of South Carolina, Columbia

29425

Medical University of South Carolina - PPDS, Charleston

30281

SleepCare Research Institute Inc, Stockbridge

30342

NeuroTrials Research Inc., Atlanta

32003

Fleming Island Center For Clinical Research, Fleming Island

32405

NeuroMedical Research Institute, Panama City

32607

Sarkis Clinical Trials, Gainesville

32806

Compass Research LLC, Orlando

33009

MD Clinical, Hallandale

33024

QPS MRA, Hollywood

33143

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

33511

PAB Clinical Research, Brandon

33707

Clinical Research Group of St Petersburg Inc, St. Petersburg

33765

Saint Francis Sleep Allergy and Lung Institute, Clearwater

35501

Jasper Summit Research LLC, Jasper

43017

Ohio Sleep Medicine Institute, Dublin

44130

Cleveland Sleep Research Center, Middleburg Heights

45212

Cincinnati

45245

Intrepid Research, Cincinnati

45255

CTI Clinical Research Center, Cincinnati

48109

University of Michigan, Ann Arbor

48314

Clinical Neurophysiology Services, Sterling Heights

48377

Henry Ford Hospital, Novi

60611

Northwestern University, Chicago

60634

Chicago Research Center Inc, Chicago

63141

St. Louis Clinical Trials, St Louis

63143

Clayton Sleep Institute, St Louis

72211

Preferred Research Partners, Little Rock

73112

Lynn Health Science Institute, Oklahoma City

77099

Pioneer Research Solutions, Houston

85306

PACT, Glendale

89104

Clinical Research Center of Nevada, Las Vegas

90404

Santa Monica Clinical Trials, Santa Monica

91786

Empire Clinical Research, Upland

92011

Carlsbad

92054

Pacific Sleep Medicine Services, Oceanside

92056

Research Center of Southern California, Oceanside

92078

Artemis Institute For Clinical Research, San Marcos

92103

Artemis Institute For Clinical Research LLC, San Diego

Pacific Research Network Inc, San Diego

92708

Southern California Research, Fountain Valley

92868

Orange County Neuropsychiatric Research Center, LLC, Orange

SDS Clinical Trials, Inc., Orange

98101

Seattle

98122

Swedish Medical Center, Seattle

Unknown

Research Centers of America, Oakland Park

Sleep and Fatigue Institute, Calgary

Medical Arts Health Research Group, Kelowna

Somni Research Inc., Markham

Tri Hospital Sleep West, Mississauga

Sleep Wake Disorders Clinic, Scarborough Village

Toronto Sleep Institute, Toronto

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

Zentralinstitut für Seelische Gesundheit, Mannheim

Universitätsklinikum Schleswig-Holstein, Lübeck

Advanced Sleep Research GmbH, Berlin

Emovis GmbH, Berlin

Studienzentrum Wilhelmshöhe, Kassel

Klinikum rechts der Isar der Technischen Universität München, München

Universitätsklinikum Münster, Münster

Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin

Ospedale Bellaria, Bologna

Ospedale San Raffaele S.r.l. - PPDS, Milan

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

Clinica Universidad de Navarra, Pamplona

Hospital San Rafael, A Coruña

Hospital Clinic de Barcelona, Badalona

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

Hospital Universitario Araba - Txagorritxu, Vitoria-Gasteiz

Papworth Hospital, Cambridge

University of Surrey, Guildford

Guys Hospital, London

Royal Stoke University Hospital, Stoke-on-Trent

02459

Neurocare Inc, Newton

08009

Hassman Research Institute, Berlin

07724

CLINiLABS, Inc., Eatontown

19104-3309

University of Pennsylvania, Philadelphia

L3R 1A3

Markham

M4P 1P2

Toronto

08025

Barcelona

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT02783729 - Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) | Biotech Hunter | Biotech Hunter