Zaleplon

The Basics

What is Zaleplon?

Used on a short-term basis to treat insomnia.

Brand names for Zaleplon

Sonata

How Zaleplon is classified

Hypnotics and Sedatives

Zaleplon During Pregnancy

Zaleplon pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Zaleplon while pregnant

In embryofetal development studies in rats and rabbits, oral administration of up to 100 mg/kg/day and 50 mg/kg/day, respectively, to pregnant animals throughout organogenesis produced no evidence of teratogenicity. These doses are equivalent to 49 (rat) and 48 (rabbit) times the maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis. In rats, preand postnatal growth was reduced in the offspring of dams receiving 100 mg/kg/day. This dose was also maternally toxic, as evidenced by clinical signs and decreased maternal body weight gain during gestation. The no-effect dose for rat offspring growth reduction was 10 mg/kg (a dose equivalent to 5 times the MRHD of 20 mg on a mg/m2 basis). No adverse effects on embryofetal development were observed in rabbits at the doses examined. In a pre-and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of 7 mg/kg/day or greater during the latter part of gestation and throughout lactation. There was no evidence of maternal toxicity at this dose. The no-effect dose for offspring development was 1 mg/kg/day (a dose equivalent to 0.5 times the MRHD of 20 mg on a mg/m2 basis). When the adverse effects on offspring viability and growth were examined in a cross-fostering study, they appeared to result from both in utero and lactational exposure to the drug. There are no studies of zaleplon in pregnant women; therefore, Sonata® (zaleplon) is not recommended for use in women during pregnancy.

Taking Zaleplon While Breastfeeding

What are recommendations for lactation if you're taking Zaleplon?

Because of the low levels of zaleplon in breastmilk and its short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Maternal / infant drug levels

Because of the low levels of zaleplon in breastmilk and its short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Possible effects of Zaleplon on milk supply

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

Possible alternatives to Zaleplon

Zolpidem.