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Zaleplon Pregnancy and Breastfeeding Warnings

Zaleplon is also known as: Sonata

Medically reviewed by Last updated on Feb 6, 2019.

Zaleplon Pregnancy Warnings

Use is not recommended during pregnancy.

US FDA pregnancy category: C

Animal studies revealed no evidence of teratogenicity; however, reduced pre- and postnatal growth, increased stillbirths, postnatal mortality, decreased physical development, and impaired female fertility have been observed. Adverse effects on animal offspring viability and growth appeared to result from both in utero and lactational exposure to this drug. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Zaleplon Breastfeeding Warnings

Use is not recommended during breastfeeding.

Excreted into human milk: Yes

-Due to the short half-life and low levels excreted into breast milk, amounts of this drug ingested by a breastfed infant are small.
-The effects in the nursing infant are unknown.

Using the data from a study of 5 nursing mothers who were given a single oral dose (10 mg) of this drug, an exclusively breastfed infant would receive an estimated maximum of 2.1 mcg/kg daily or about 1.4% of the maternal weight-adjusted dosage.

See references

References for pregnancy information

  1. "Product Information. Sonata (zaleplon)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. "Product Information. Sonata (zaleplon)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.