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

• ClinicalTrials.gov Identifier: NCT03786120
• Recruitment Status: Recruiting
• First Posted: December 24, 2018
• Last Update Posted: April 8, 2019
• Sponsor: Rhode Island Hospital
• Collaborator: Vitae Industries, Inc
• Information provided by (Responsible Party): Angela Jarman, Rhode Island Hospital

Tracking Information

• First Submitted Date: January 24, 2018
• First Posted Date: December 24, 2018
• Last Update Posted Date: April 8, 2019
• Actual Study Start Date: January 31, 2019
• Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2018)

Sleep Quality [ Time Frame: 7 days ]

This will be based on the sleep journal

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 20, 2018)

Side Effects [ Time Frame: 7 days ]

Including daytime drowsiness, night walking/eating

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep
• Official Title: The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Health Women with Disordered Sleep
• Condition: Sleep Disorder

Intervention

Drug: Zolpidem

PO sleep aid in various doses

Study Groups/Cohorts

• 1
  First 25 subjects
  Intervention: Drug: Zolpidem
• 2
  Second cohort of 25 subjects
  Intervention: Drug: Zolpidem

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Angela Jarman, MD MPH; 9196327961; angela.jarman@gmail.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03786120
• Other Study ID Numbers: Ambien Study
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Angela Jarman, Rhode Island Hospital
• Study Sponsor: Rhode Island Hospital
• Collaborators: Vitae Industries, Inc

Investigators

• Principal Investigator: Bruce Becker, MD; Lifespan

• PRS Account: Rhode Island Hospital
• Verification Date: April 2019