An increased risk of congenital malformations during the first trimester of pregnancy has been suggested. This drug passes the placental barrier and is present in the umbilical cord blood at or near maternal plasma levels.

Use should be avoided especially during the first trimester

Risk Summary: An increased risk of congenital malformations has been associated with minor tranquilizers including this drug.

Comments: Women of childbearing potential should be advised of risks.

See references

Use is not recommended

Excreted into human milk: Yes

Comment: Monitor infant for sedation, especially if mother is concurrently taking other drugs that may cause sedation.

Breast milk concentrations of this drug have been found to be up to 4 times those in maternal plasma. While it may not be a reason to discontinue breastfeeding, other agents may be preferred due to limited information available with this drug.

See references