Trouble sleeping
zolpidem
In 2013 the FDA cut the dose for women in half after finding next-morning drowsiness — yet none of these studies looked at women's results separately.
- 64.6%
of the people in the studies were women
- 49%
of studies did not allow pregnant women
- 0%
looked at results for women separately
Was someone like me tested?
Choose the group that fits you.
Not one of these studies reported results separately for any of the groups below.
Pregnant women
49% of studies would not let pregnant women join, and we found no study that tested this medicine in pregnancy.
What do we know?
What the FDA drug label says
Taking it late in pregnancy can make newborns very sleepy and slow their breathing. It wasn't studied in pregnant women.
Good to know
Women clear zolpidem from the body more slowly than men. In 2013 the FDA cut the recommended starting dose for women in half (to 5 mg) after reports of drowsy driving the next morning.
What women report more
Compared with men taking the same medicine.
- 3.0×Physical symptoms with no clear cause
- 1.9×Hives and swelling of the face, lips or throat
- 1.9×Changes to the front of the eye
- 1.6×Autoimmune problems (the body attacking itself)
How many times more often women reported each problem than men taking the same medicine, based on reports to the FDA. This is a warning sign, not proof the medicine caused it.
Make it about you
Check it against your medicines
Check zolpidem against the medicines, pregnancy and birth control in your profile.
Join to checkAll the details
Every number behind this page.
Who was in the studies
5,061 people in 37 studies
Race
- White75.3%
- Black / African American19.2%
- Asian2.2%
- Hispanic / Latina1.1%
- Other0.6%
Studies didn't say how many of the women were Black, Asian or another race — only totals for everyone.
- Hispanic or Latina
- 13.3%
- Age 65 or older
- 5.1%
- Studies with men only
- 1
- Studies with women only
- 1
Rules that kept women out
Share of studies with each rule.
- 77%
No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
See the exact rule
“Beck Depression Inventory - II (BDI-II) score \>19 at Screening” NCT02783729
- 51%
Age limit under 65
Older women were turned away, even though they often take this medicine.
See the exact rule
“Maximum age: 64 Years.” NCT00608985
- 49%
No pregnant women
Women who were pregnant could not join.
See the exact rule
“Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug” NCT03375203
- 36%
No breastfeeding moms
Women who were breastfeeding could not join.
See the exact rule
“Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug” NCT03375203
- 33%
Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
See the exact rule
“Body Mass Index \> 33” NCT00784875
- 31%
No smokers
Women who smoke or use nicotine were turned away.
See the exact rule
“Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.” NCT00608985
What nobody checked
Share of studies that recorded each thing.
- 0%Results shown separately for women
- 0%Whether anyone was pregnant
- 0%Whether women were past menopause
- 15%Body weight (BMI)
- 39%Hispanic / Latina or not
- 72%Race
All 39 studies
Study titles and rules are shown in their original English.