Stilnox CR Use In Pregnancy & Lactation

Effects on fertility: No data available.
Use in Pregnancy: Category B3: This drug has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is uncertain in humans. The use of zolpidem is not recommended during pregnancy.
Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines or other sedative-hypnotic drugs such as zolpidem during pregnancy.
Administration of zolpidem during the late phase of pregnancy or during labor has been associated with effects on the neonates, such as hypothermia, hypotonia, feeding difficulties, and respiratory depression.
If zolpidem is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant.
Teratogenic effects: In reproductive toxicity studies, rats treated with oral zolpidem with estimated exposures (AUC) to zolpidem and its major metabolite of 41 and 15 times, respectively, the anticipated clinical exposure did not exhibit teratogenic effects but post-implantation survival index and postpartum viability of the offspring were significantly reduced. In rats, delayed ossification of foetal skull bones occurred at zolpidem and metabolite exposure levels of 8 and 3 times, respectively, the anticipated clinical exposure.
Rabbits treated with oral zolpidem with estimated exposure to zolpidem of 0.6-2.6 times the anticipated clinical exposure did not exhibit teratogenic effects, but there was increased post-implantation loss.
Although animal studies have not shown any teratogenic effects with zolpidem, the safety of zolpidem in human pregnancy has not been established.
Non teratogenic effects: Cases of severe neonatal respiratory depression have been reported when zolpidem was used with other CNS depressants at the end of pregnancy.
Infants born to mothers who took hypnotics chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended.
Use in lactation: The use of STILNOX CR in nursing women is not recommended as small quantities of zolpidem are excreted into breast milk.