Is Clorazepate safe while breastfeeding?

Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Clorazepate. The text below is quoted from that source — it is not our own verdict.

Summary of use during breastfeeding

Clorazepate is excreted into breastmilk and appears to accumulate in the serum of breastfed infants. Because the half-life of clorazepate and its active metabolite are long, timing breastfeeding with respect to the dose is of little or no benefit in reducing infant exposure. Other agents may be preferred, especially while nursing a newborn or preterm infant. If clorazepate is used, monitor the infant for sedation, poor feeding and poor weight gain.

Effects on the breastfed infant

Sedation in infants has been reported during maternal use of diazepam which has nordiazepam as its active metabolite.[3,4] Concern has also been expressed that nordiazepam may compete with bilirubin for hepatic glucuronide conjugation in the neonate.[2]

Effects on milk supply

Relevant published information was not found as of the revision date.

Levels in milk

Clorazepate is a prodrug of nordiazepam (desmethyldiazepam) which is the primary active metabolite of diazepam.

Maternal Levels. After a single 20 mg intramuscular dose of clorazepate in 7 women, milk nordiazepam levels ranged from 7.5 to 15.5 mcg/L at 2 days after the dose and 6 to 12 mcg/L at 4 days after the dose.[1]

Infant Levels. Nordiazepam has been found in infants' serum in levels higher than milk levels, indicating accumulation, and only slightly lower than adult therapeutic levels after diazepam use by the mother.[2,3]

After a single 20 mg intramuscular dose of clorazepate in 7 women, serum levels of their breastfed infants ranged from trace levels in 5 of the infants to 4 and 7.5 mcg/L in the others on the second day after the dose. On the fourth day after the dose, infant serum levels was a trace amounts in one and ranged from 4 to 8.5 mcg/L in the others, indicating accumulation in infant serum.[1]

Alternatives LactMed lists

Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Clorazepate” (LM345). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.