Zolpidem Pregnancy and Breastfeeding Warnings
Zolpidem Pregnancy Warnings
There are no controlled data in human pregnancy. Chronic use of hypnotics during late pregnancy may be associated with neonatal withdrawal symptoms. Animal studies have revealed evidence of incomplete ossification and increased postimplantation fetal loss at doses greater than seven times the maximum recommended human dose or higher; however, teratogenicity was not observed at any dose level. According to one case report, zolpidem apparently crosses the placenta. In this report, a sample of cord blood at delivery revealed zolpidem (41 ng/mL) after an unknown amount was ingested by the mother for an unknown duration, possibly throughout pregnancy. The neonate did not exhibit withdrawal symptoms throughout the 48 hour observation period. Postmarketing cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS depressants. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Zolpidem is only recommended for use during pregnancy when benefit outweighs risk.
Zolpidem Breastfeeding Warnings
The excretion of zolpidem in human milk is very low (below 0.02%) and most of it takes place during the first 3 hours following drug intake. Zolpidem is considered probably compatible with breast-feeding by Briggs et al.
Caution is recommended. Excreted into human milk: Yes The effects in the nursing infant are unknown.
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