Ambien - Warnings & Precautions

Impairment of fertility:

In a rat reproduction study, the high dose (100 mg base/kg) of zolpidem resulted in irregular estrus cycles and prolonged precoital intervals, but there was no effect on male or female fertility after daily oral doses of 4 to 100 mg base/kg or 5 to 130 times the recommended human dose in mg/m2. No effects on any other fertility parameters were noted.

Pregnancy

Teratogenic effects:

Pregnancy Category B.

Studies to assess the effects of zolpidem on human reproduction and development have not been conducted.

Teratology studies were conducted in rats and rabbits.

In rats, adverse maternal and fetal effects occurred at 20 and 100 mg base/kg and included dose-related maternal lethargy and ataxia and a dose-related trend to incomplete ossification of fetal skull bones. Underossification of various fetal bones indicates a delay in maturation and is often seen in rats treated with sedative/hypnotic drugs. There were no teratogenic effects after zolpidem administration. The no-effect dose for maternal or fetal toxicity was 4 mg base/kg or 5 times the maximum human dose on a mg/m2 basis.

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In rabbits, dose-related maternal sedation and decreased weight gain occurred at all doses tested. At the high dose, 16 mg base/kg, there was an increase in postimplantation fetal loss and underossification of sternebrae in viable fetuses. These fetal findings in rabbits are often secondary to reductions in maternal weight gain. There were no frank teratogenic effects. The no-effect dose for fetal toxicity was 4 mg base/kg or 7 times the maximum human dose on a mg/m2 basis.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic effects:

Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. However, children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy.