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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

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Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: February 15, 2023.

Estimated reading time: 1 minute

CASRN: 151319-34-5

image 135017416 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Little information is available on the use of zaleplon during breastfeeding. A safety scoring system finds zaleplon to be not recommended during breastfeeding.[1] However, the low levels of zaleplon in breastmilk and its short half-life indicate that amounts ingested by the infant are small and would not be expected to cause any adverse effects in older breastfed infants. Other agents may be preferred in newborn and preterm infants. Monitor the infant for sedation, poor feeding and poor weight gain.

Drug Levels

Maternal Levels. Five nursing mothers who were at least 14 days postpartum were given a single oral dose of zaleplon 10 mg. The peak milk level averaged 14 mcg/L at 1.2 hours after the dose. The mean half-life in milk was 1.1 hours.[2] Using the peak milk level data from this study, an exclusively breastfed infant would receive an estimated maximum of 2.1 mcg/kg daily with this maternal dosage regimen or about 1.4% of the maternal weight-adjusted dosage.

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



Uguz F. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther. 2021;28:e118–e126. [PubMed: 30601177]
Darwish M, Martin PT, Cevallos WH, et al. Rapid disappearance of zaleplon from breast milk after oral administration to lactating women. J Clin Pharmacol. 1999;39:670–4. [PubMed: 10392321]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Milk, Human

Hypnotics and Sedatives

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK501264PMID: 30000323


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