NCT01106859
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
See it on ClinicalTrials.gov ↗40 people
50%
50%
20 womenmiddle line = equal numbers20 men
- Phase
- PHASE1
- Paid for by
- Transcept Pharmaceuticals
- Finished
- 2010-09
- Health conditions
- Insomnia
- Who could join
- Anyone
- Ages
- 21 Years – 64 Years
- Average age
- mean 37 years
- Age 65+
- Not reported
- Weight (BMI)
- mean 23.2 kilograms/meter^2
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 97.5% · Other 2.5% · Black / African American 0% · Asian 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 64 Years.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“…st-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contrace…”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“BMI \> 29 Kg/M\^2”
- No smokers
Women who smoke or use nicotine were turned away.
“Smokes more than 10 cigarettes/day”
Study titles and rules are shown in their original English.