Zaleplon Pregnancy and Breastfeeding Warnings

Brand names: Sonata

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Zaleplon Pregnancy Warnings

Use is not recommended during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of reduced pre- and postnatal growth, increased stillbirths, postnatal mortality, decreased physical development, and impaired female fertility. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Zaleplon Breastfeeding Warnings

Use is not recommended during breastfeeding.

Excreted into human milk: Yes

Comments:
-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, 10 mg dose orally, 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. Highest levels were observed approximately 1 hour after administration.

See references

Further information

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