Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Public ClinicalTrials.gov record NCT02783729. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02783729
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,006 participants
Conditions and interventions
Conditions
Interventions
- Lemborexant Drug
- Lemborexant-matched placebo Drug
- Zolpidem tartrate Drug
- Zolpidem-matched placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2016 (Actual)
- Primary completion
- Jan 30, 2018 (Actual)
- Completion
- Jan 30, 2018 (Actual)
- Last update posted
- Nov 12, 2024
2016 – 2018
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jasper Summit Research LLC | Jasper | Alabama | 35501 | — |
| PACT | Glendale | Arizona | 85306 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Not listed | Carlsbad | California | 92011 | — |
| Southern California Research | Fountain Valley | California | 92708 | — |
| Pacific Sleep Medicine Services | Oceanside | California | 92054 | — |
| Research Center of Southern California | Oceanside | California | 92056 | — |
| Orange County Neuropsychiatric Research Center, LLC | Orange | California | 92868 | — |
| SDS Clinical Trials, Inc. | Orange | California | 92868 | — |
| 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 | — |
| Empire Clinical Research | Upland | California | 91786 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Saint Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | — |
| Fleming Island Center For Clinical Research | Fleming Island | Florida | 32003 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| QPS MRA | Hollywood | Florida | 33024 | — |
| Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA) | Miami | Florida | 33143 | — |
| Research Centers of America | Oakland Park | Florida | — | — |
| Compass Research LLC | Orlando | Florida | 32806 | — |
| NeuroMedical Research Institute | Panama City | Florida | 32405 | — |
| Clinical Research Group of St Petersburg Inc | St. Petersburg | Florida | 33707 | — |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | — |
| SleepCare Research Institute Inc | Stockbridge | Georgia | 30281 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Chicago Research Center Inc | Chicago | Illinois | 60634 | — |
| Helene A Emsellem MD PC | Chevy Chase | Maryland | 20815 | — |
| Sleep Disorders Center of the Mid-Atlantic | Glen Burnie | Maryland | 21061 | — |
| Neurocare Inc | Newton | Massachusetts | 02459 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Novi | Michigan | 48377 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| CLINiLABS, Inc. | Eatontown | New Jersey | 07724 | — |
| Winthrop University Hospital | Garden City | New York | 11530 | — |
| Clinical Research Unit | New York | New York | 10019 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Sleep Medicine Centers of Western New York | West Seneca | New York | 14224 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| Wilmington Health Associates | Wilmington | North Carolina | 28401 | — |
| Not listed | Cincinnati | Ohio | 45212 | — |
| Intrepid Research | Cincinnati | Ohio | 45245 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Cleveland Sleep Research Center | Middleburg Heights | Ohio | 44130 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-3309 | — |
| Medical University of South Carolina - PPDS | Charleston | South Carolina | 29425 | — |
| Sleepmed of South Carolina | Columbia | South Carolina | 29201 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| Sleep Disorders Center of the Mid-Atlantic | Vienna | Virginia | 22182 | — |
| Not listed | Seattle | Washington | 98101 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02783729, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02783729 live on ClinicalTrials.gov.