A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
Public ClinicalTrials.gov record NCT04009577. 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, Pilot Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant for the Treatment of Insomnia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04009577
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 53 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 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
- Jul 15, 2019 (Actual)
- Primary completion
- Mar 17, 2020 (Actual)
- Completion
- Jun 26, 2020 (Actual)
- Last update posted
- Apr 12, 2021
2019 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PACT | Glendale | Arizona | 85306 | — |
| Northern California Research Corp | Sacramento | California | 95821 | — |
| Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS | San Diego | California | 92103 | — |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | — |
| Fleming Island Center For Clinical Research - ERN-PPDS | Fleming Island | Florida | 32003 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions Inc | Orlando | Florida | 32801 | — |
| NeuroTrials Research Inc. - BTC - PPDS | Atlanta | Georgia | 30342 | — |
| SleepCare Research Institute Inc | Stockbridge | Georgia | 30281 | — |
| Chicago Research Center Inc - ClinEdge - PPDS | Chicago | Illinois | 60634 | — |
| Centennial Medical Group - Elkridge - Rx Trials | Elkridge | Maryland | 21075 | — |
| Albuquerque Neurosciences Inc | Albuquerque | New Mexico | 87109 | — |
| Clinilabs Drug Development Corporation | New York | New York | 10019 | — |
| CTI Clinical Research Center - ClinEdge - PPDS | Cincinnati | Ohio | 45212 | — |
| Clinical Neuroscience Solutions Inc | Memphis | Tennessee | 38119 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04009577, 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 Apr 12, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04009577 live on ClinicalTrials.gov.