Animal studies have shown evidence of retarded or impaired skeletal formation, and impaired viability and weight gain. There are no controlled data in human pregnancy.

Benzodiazepines cross the placenta and may cause hypotonia, respiratory depression, and hypothermia in the newborn infant. Withdrawal symptoms in newborn infants have been reported with this class of drug. Also, neonatal flaccidity has been reported in an infant born of a mother who had been receiving benzodiazepines.

To monitor the outcomes of pregnant women exposed to this drug, a National Pregnancy Registry for Other Psychiatric Medications has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: Use of this drug later in pregnancy may increase the risk of fetal sedation and/or withdrawal symptoms.

Comments:
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
-Neonates who are exposed to chronic benzodiazepine use may be at risk for withdrawal symptoms.
-A pregnancy exposure registry is available.

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Some authorities state that use should be avoided.
-The American Academy of Pediatrics considers similarly acting drugs agents that may be of concern during breastfeeding.

Little information is available on the use of this drug during breastfeeding; an alternate short-acting hypnotic may be preferred (e.g., oxazepam or lorazepam), particularly when nursing a newborn or preterm infant. Because of its relatively short half-life, occasional use during breastfeeding in an older infant should pose little risk; however, the infant should be monitored for excessive drowsiness.

See references