Zolpidem Pregnancy and Breast Feeding Warnings

Zolpidem is also known as: Ambien, Ambien CR, Edluar, Zolpimist

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zolpidem Extended-Release Tablets while you are pregnant. Zolpidem Extended-Release Tablets may cause prolonged sleep in the fetus when used during the last weeks of pregnancy. Zolpidem Extended-Release Tablets is found in breast milk. If you are or will be breast-feeding while you take Zolpidem Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Zolpidem Pregnancy Warnings

Zolpidem has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of incomplete ossification and increased postimplantation fetal loss at doses greater than seven times the maximum recommended human dose or higher; however, teratogenicity was not observed at any dose level. There are no controlled data in human pregnancy. In one case report, zolpidem was found in cord blood at delivery. Zolpidem is only recommended for use during pregnancy when benefit outweighs risk.

According to one case report, zolpidem apparently crosses the placenta. In this report, a sample of cord blood at delivery revealed zolpidem (41 ng/mL) after an unknown amount was ingested by the mother for an unknown duration, possibly throughout pregnancy. The neonate did not exhibit withdrawal symptoms throughout the 48 hour observation period.

Zolpidem Lactation Warnings

Zolpidem is excreted into human milk in very small amounts. Adverse effects in nursing infants have not been reported. Zolpidem is considered compatible with breast-feeding by the American Academy of Pediatrics.

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