Is Zolpidem (Ambien) safe to use during breastfeeding?

Zolpidem and Breastfeeding

Zolpidem can be used during breastfeeding with appropriate precautions, but breastfed infants must be closely monitored for excess sedation, hypotonia, and respiratory depression. 1

FDA Safety Guidance

The FDA label explicitly addresses zolpidem use during lactation with specific recommendations:

• Zolpidem is present in human breast milk and there are documented reports of excess sedation in infants exposed through breastmilk 1
• Infants exposed to zolpidem through breastmilk require monitoring for excess sedation, hypotonia, and respiratory depression 1
• A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after zolpidem administration to minimize drug exposure to the breastfed infant 1

Clinical Decision Framework

The FDA recommends weighing three factors:

• The developmental and health benefits of breastfeeding 1
• The mother's clinical need for zolpidem 1
• Any potential adverse effects on the breastfed infant from zolpidem or from the underlying maternal condition 1

Pharmacokinetic Data Supporting Limited Transfer

Research demonstrates reassuring pharmacokinetic profiles:

• Zolpidem excretion into breast milk is very low (below 0.02% of the maternal dose), with most excretion occurring during the first 3 hours following drug intake 2
• The milk-to-plasma ratio at 3 hours is 0.13, indicating limited transfer 2
• Zolpidem was not detected in infants' serum even after breastfeeding in a case series of three mother-infant pairs 3
• The calculated relative infant dose through breast milk was 2.7% at 2.2 hours after maternal dosing 4

Clinical Outcomes in Exposed Infants

Available case reports show generally favorable outcomes:

• No abnormal developmental findings were observed in infants at 1-month health checkups following breastfeeding exposure 3
• One case series reported normal infant outcomes with no adverse effects despite detectable zolpidem in breast milk 4
• The exposure doses through breastfeeding are small, which likely explains the rare detection in infants' serum 3

Practical Implementation Strategy

If zolpidem is deemed necessary during breastfeeding:

• Administer zolpidem immediately after breastfeeding or right before the infant's longest sleep period to minimize infant exposure 2
• Monitor the infant vigilantly for increased sleepiness (more than usual), breathing difficulties, or limpness 1
• Seek immediate medical care if any signs of sedation, hypotonia, or respiratory depression appear 1
• Consider pump-and-discard for 23 hours after each dose if the mother wants to minimize infant exposure completely 1

Important Caveats

• The available safety data comes from limited case reports and small case series, not controlled trials 3, 4
• Neonates exposed to zolpidem during late third trimester pregnancy may already have respiratory depression and sedation at birth, which could compound breastfeeding exposure risks 1
• Larger studies are needed to fully establish safety, but current evidence suggests low transfer and minimal infant exposure 3