At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 53 enrolled
Drug / intervention
LEM 5 mg +1 moredrug
Likely dose
LEM 5 mgfrom 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 Multicenter, Pilot Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant for the Treatment of Insomnia
In Brief
A Phase 3 clinical trial evaluating LEM 5 mg and LEM 10 mg for Insomnia. Completed, enrolled 53 participants across 17 sites.
Detailed Summary
The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartJul 2019
Primary CompletionMar 2020
Study CompletionJun 2020
TodayJul 2026
First PostedJul 5, 2019
Enrollment StartJul 15, 2019
Primary CompletionMar 17, 2020
Study CompletionJun 26, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.0 years ago
Interventions
LEM 5 mgdrug
LEM tablet.
LEM 10 mgdrug
LEM tablet.