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.