The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep
Public ClinicalTrials.gov record NCT03786120. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Sleep difficulties are very common in adults in the U.S. today. Zolpidem (Ambien) is often prescribed as a first line agent to treat sleep difficulties in patients presenting with sleep related complaints to Primary Care Practitioners (PCP's). Zolpidem is currently available in two doses, 10 and 5 mg. These doses were developed in clinical studies carried out primarily on men. The first dose made clinically available, 10 mg, resulted in morbidity and mortality in many women because women metabolize Zolpidem at a slower rate than men, thus the half-life is longer. Women taking Zolpidem often had morning drowsiness, persistent sleepiness, and difficulty with tasks requiring coordination and judgement, such as motor vehicle operation. There were a number of well publicized motor vehicle crashes and fatalities attributed to Zolpidem, mostly among women. The company then produced a 5 mg dose; however, some women still reported side effects at the lower dose, suggesting persistent drug levels in the morning, when the drug purportedly should have been cleared from the body. These women would likely benefit from a lower dose, a dose personalized for their individual metabolisms and sleep difficulties. Lower doses of Zolpidem are only available from compounding pharmacies, which are not common, are expensive, do not take many insurances, and are not offered as an option to most patients. Vitae Industries, Inc. is a start-up tech company located in Providence, founded by a Brown University graduate, a chemical engineer, who has developed technology that can provide precisely varied amounts of drug for specific and variable personalized patient dosing. Personalized medicine is an area of great research and clinical interest to the medical community at large and the Brown University Medical School in particular. Brown also has a growing focus on issues of sex and gender in the rendering of clinical medical care. This technology has the potential to address both of these areas, providing the possibility of very specific, tailored drug dosing for men and women. This research was developed as a proof of concept study which will be carried out as a collaboration between Brown University Medical School/Lifespan physicians and the technical staff at Vitae Industries, Inc.. This work will be foundational and will serve as the medical and scientific justification for Vitae Industry's providing patient specific dosing of medications. For the purposes of this study, the medication to be tested, Zolpidem (Ambien) will be compounded by a licensed compounding Rhode Island pharmacy, PhusionRx, using standardized approaches to compounding and formulating pharmaceutical products. This study will use low doses of Zolpidem formulated by the licensed compounding pharmacy, PhusionRx. The investigators will provide graduated doses of Zolpidem to women participants meeting inclusion criteria who present to their primary care physician complaining of difficulty achieving satisfactory sleep. Participants will start at a dose of 0.5 mg of Zolpidem. Each day the quality of their sleep will be assessed by self-report. If they have not achieved satisfactory sleep at the starting dose of 0.5 mg, the will increase their dose daily by 0.5 mg until they reach the standard 5 mg dose or satisfactory sleep is achieved.
Study identification
- NCT ID
- NCT03786120
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2019
- Primary completion
- Jul 30, 2019
- Completion
- Dec 30, 2019
- Last update posted
- Apr 7, 2019
2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| rhode island Hospital | Sacramento | California | 95819 | Recruiting |
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 NCT03786120, 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 7, 2019 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03786120 live on ClinicalTrials.gov.