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

Zolpidem

References

1.

Uguz F. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther. 2021;28:e118–e126. [PubMed: 30601177]

2.

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 Name

Zaleplon

CAS Registry Number

151319-34-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Hypnotics and Sedatives