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The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03786120
Recruitment Status : Unknown
Verified April 2019 by Angela Jarman, Rhode Island Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2018
Last Update Posted : April 8, 2019
Vitae Industries, Inc
Information provided by (Responsible Party):
Angela Jarman, Rhode Island Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Sleep Disorder Drug: Zolpidem

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
First 25 subjects
Drug: Zolpidem
PO sleep aid in various doses

Second cohort of 25 subjects
Drug: Zolpidem
PO sleep aid in various doses

Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: 7 days ]
    This will be based on the sleep journal

Secondary Outcome Measures :
  1. Side Effects [ Time Frame: 7 days ]
    Including daytime drowsiness, night walking/eating

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health Women with Disordered Sleep

Inclusion Criteria:

  • biologically female
  • age 18-65
  • English speaking
  • difficulty sleeping

Exclusion Critieria:

  • diagnosed significant cardiac, pulmonary, neuromuscular, hepatic, renal or major psychiatric disease (as ascertained by the study physicians)
  • diagnosed sleep pathology such as sleep apnea or prior work-up for sleep pathology
  • recent (two weeks prior) treatment of any kind for sleep disorder including herbal or over the counter treatments, psychiatric medications including anxiolytics except for SSRI's.
  • pregnant or trying to become pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03786120

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Contact: Angela Jarman, MD MPH 9196327961

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United States, California
rhode island Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Angela Jarman    919-632-7961   
Sponsors and Collaborators
Rhode Island Hospital
Vitae Industries, Inc
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Principal Investigator: Bruce Becker, MD Lifespan
  Study Documents (Full-Text)

Documents provided by Angela Jarman, Rhode Island Hospital:
Informed Consent Form  [PDF] November 7, 2018

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Responsible Party: Angela Jarman, Teaching Fellow, Rhode Island Hospital Identifier: NCT03786120    
Other Study ID Numbers: Ambien Study
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action