Zolpidem

Pregnancy

Fung et al. (2026) studied 4,281,579 US pregnancies in a population-based cohort; 92.1% of first-trimester Z-drug-exposed pregnancies involved zolpidem. Across zolpidem, zaleplon, and eszopiclone, the adjusted pooled relative risk for major malformations overall was 1.01 (95% CI 0.95 to 1.08). The study included liveborn infants and reported grouped Z-drug exposure, so it does not provide a zolpidem-only estimate or answer miscarriage risk. Wang et al. (2010) compared 2,497 zolpidem-treated pregnancies with 12,485 controls and found adjusted odds ratios of 1.39 (95% CI 1.17 to 1.64) for low birth weight and 1.49 (95% CI 1.28 to 1.74) for preterm delivery. MotherToBaby reports mixed findings and notes that some studies did not consider other medicines, smoking, alcohol or drug use, or the underlying condition. Wang's abstract does not list covariates, so it cannot confirm which factors were controlled. These observational associations do not establish cause. The NHS says zolpidem is not usually recommended in pregnancy because little is known about its effects on the baby. The Ambien label reports limited postmarketing neonatal respiratory-depression cases after maternal use and recommends monitoring after exposure during pregnancy and labor.

Breastfeeding

Pons et al. (1989) gave a single 20 mg dose to five nursing mothers 3 to 4 days after delivery. At 3 hours, milk contained 0.004% to 0.019% of the administered dose; zolpidem was not detected at 13 or 16 hours. MotherToBaby summarizes the small milk study and a case report as six women, with no reported problems in their babies. LactMed reports low milk levels and rapid elimination, but its no-expected-effect statement is limited to older infants who do not feed overnight after the mother's dose. LactMed also reports manufacturer reports of excess infant sedation, notes that some expert opinion advises against use because documentation is limited, and advises monitoring for sedation, poor feeding, and poor weight gain. The NHS says occasional doses for a short time may be considered if the baby is healthy. The Ambien label reports excess infant sedation and says a lactating woman may consider pumping and discarding milk during treatment and for 23 hours after administration. Saito et al. (2022) reported three cases, with oxygen intervention in one term infant that resolved on the first day; the abstract reported no abnormal findings at one-month checks and says larger studies are needed. These very small studies cannot rule out uncommon effects.

What was tested

The pregnancy evidence includes a US population-based cohort of first-trimester exposure to three Z-drugs, a Taiwanese claims and birth-certificate cohort of zolpidem users, and studies summarized by MotherToBaby. The newborn evidence includes label-reported postmarketing cases and a three-case zolpidem case series. Breastfeeding evidence includes a five-mother single-dose milk-transfer study, a case report, and a three-case series. LactMed, MotherToBaby, NHS, FDA, MHRA, and the Ambien label provide evidence reviews or guidance. The 2026 placental cell-model study tested cell viability and hormone production in vitro, not pregnancy outcomes in people.