Clotiazepam use while Breastfeeding

Summary of Use during Lactation

Clotiazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. Very little information is available on the passage of clotiazepam into milk. One review recommends avoiding clotiazepam during breastfeeding.[1] An alternate drug is preferred, especially while nursing a newborn or preterm infant. If clotiazepam is used, monitor the infant for sedation, poor feeding and poor weight gain.

Drug Levels

Maternal Levels. A woman who was taking oral clotiazepam 5 mg daily donated a milk sample between 3 and 6 days postpartum at 1 hour after a dose at the estimated peak serum concentration. She had a 1-hour milk level of 16.3 mcg/L.[2]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Lorazepam, Oxazepam, Temazepam

References

1.

Bascoul C, Franchitto L, Parant O, et al. [Psychotropic drugs during pregnancy and lactation: Development practice]. Presse Med 2015;44:271–83. [PubMed: 25595818]

2.

Nishimura A, Furugen A, Umazume T, et al. Benzodiazepine concentrations in the breast milk and plasma of nursing mothers: Estimation of relative infant dose. Breastfeed Med 2021;16:424-31. [PubMed: 33449825]

Substance Name

Clotiazepam

CAS Registry Number

33671-46-4

Drug Class

Breast Feeding

Lactation

Milk, Human

Hypnotics and Sedatives

Anti-Anxiety Agents

Benzodiazepines