Ambien is a proprietary name for a generic sleeping medication called zolpidem tartrate. Available in both a regular tablet and an extended-release form called Ambien CR, this drug corrects the underlying chemical balance in the brain to promote relaxation and uninterrupted sleep for those with insomnia. Women who are already taking Ambien CR before they become pregnant, as well as expectant mothers who develop insomnia, may want to know how safe the drug is to the unborn child.
Animal Studies
When the maximum recommended human dose of oral zolpidem is given to pregnant rats and rabbits, there are no observable birth defects or other adverse effects in their offspring, according to Sanofi-Aventis, the manufacturer of Ambien CR. However, baby rats whose mothers took 20 to 100 times the regular dose were born with thinner bones in their skulls. In rabbits, higher-than-normal doses caused miscarriages and thinning of the breastbone in those babies that did survive pregnancy.
Human Studies
Drug testing in pregnant women presents moral and ethical considerations. To date, Sanofi-Aventis says, there have been no studies in human offspring of women who took Ambien CR during pregnancy.
Potential
In at least one case, zolpidem was detected in the umbilical cord blood of a baby born to a woman who took zolpidem during pregnancy. Infants who are born to mothers who used sedative-hypnotic drugs "may be at some risk for withdrawal symptoms from the drug during the postnatal period," says Sanofi-Aventis. These babies may also have abnormally low muscle tone after birth. Sanofi-Aventis reports cases of severe respiratory distress in newborns whose mothers took zolpidem along with other central nervous system depressant medications at the end of their pregnancy.
Expert Insight
The U.S. Food and Drug Administration identified Ambien as a category C drug for pregnant women. According to WomensHealth.gov, category C drugs can potentially harm the fetus if they're taken during pregnancy, but it's possible that the benefits to the mother outweigh the risk to the unborn child.
Prevention/Solution
Pregnant women who do use Ambien CR can benefit from the National Sleep Foundation's recommendations for sleep aids. If the drug is taken nightly, it should be limited to the short-term. If it's taken for long periods of time, it should be used intermittently. It's also a good idea to follow healthy sleep practices like planned sleep patterns and relaxing bedtime routines.
