Animal models have failed to reveal evidence of morphological development. However, data for other benzodiazepines have indicated possible adverse developmental effects (long-term effects on neurobehavioral and immunological function) in animals. There are no controlled data in human pregnancy

US 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-A syndrome of hypothermia, hypotonia, respiratory depression and difficulty feeding may occur in in infants of mothers administered benzodiazepines immediately prior to or during childbirth.
-Withdrawal symptoms may occur in neonates whose mothers were taking benzodiazepines late in pregnancy.

See references

Use with caution.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern, especially when used for long periods.
-This drug and its metabolites are excreted into human milk and both the drug and its metabolites may accumulate in the breastfed infant. Some experts recommend that an alternative drug should be considered, especially for newborn or preterm infants (e.g., zaleplon, zolpidem).

Based on a study in 4 women receiving a single dose of 15 mg, estimated human milk concentrations of 2.3% maternal weight-adjusted dose are achieved. Due to the expected accumulation with repeat dosing, an exclusively breastfed infant may receive 0.19% of the mother's absolute dose or 4% of the maternal weight-adjusted dose.

See references