At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 971 enrolled
Drug / intervention
lemborexant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)
In Brief
A Phase 3 clinical trial evaluating lemborexant and Placebo for Insomnia Disorder. Completed, enrolled 971 participants across 114 sites in 12 countries.
Detailed Summary
The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder
CountriesCanada, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Romania, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartNov 2016
Primary CompletionJan 2019
TodayJul 2026
First PostedNov 2, 2016
Enrollment StartNov 15, 2016
Primary CompletionJan 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.7 years ago
Interventions
lemborexantdrug
Placebodrug