Trials / Completed
CompletedNCT04009577
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
A Multicenter, Pilot Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant for the Treatment of Insomnia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEM 5 mg | LEM tablet. |
| DRUG | LEM 10 mg | LEM tablet. |
Timeline
- Start date
- 2019-07-15
- Primary completion
- 2020-03-17
- Completion
- 2020-06-26
- First posted
- 2019-07-05
- Last updated
- 2021-04-12
- Results posted
- 2021-04-12
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04009577. Inclusion in this directory is not an endorsement.