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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Zolpidem

Last Revision: April 18, 2022.

Estimated reading time: 1 minute

CASRN: 82626-48-0

image 135019994 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

The levels of zolpidem in breastmilk are low and is somewhat rapidly eliminated from milk, so it would not be expected to cause any adverse effects in older breastfed infants who does not breastfeed during the night after the mother’s dose. The manufacturer states that excess sedation in infants exposed to zolpidem through breastmilk has been reported, although details are lacking. Some expert opinion recommends against zolpidem use during breastfeeding, primarily because of minimal documentation.[1] Monitor infants for excess sedation, hypotonia, and respiratory depression.

Drug Levels

Maternal Levels. Five nursing mothers who were 3 to 4 days postpartum were given a single oral dose of zolpidem 20 mg. Milk collected 3 hours after the dose contained between 0.76 and 3.88 mcg of zolpidem. This corresponded to 0.004 to 0.019% of the maternal dosage. The drug was undetectable (<0.5 mcg/L) in milk 13 and 16 hours after the dose. The authors estimated the half-life in milk to average 2.6 hours.[2]

A woman was taking zolpidem 5 mg nightly for sleep. Breastmilk concentrations were measured at 3 times postpartum: day 1 at 8.2 hours after a dose the concentration was 12.8 mcg/L; day 2 at 9 hours after the dose the concentration was 6.4 mcg/L; day 3 at 2.2 hours after the dose the concentration was 26.5 mcg/L. The authors estimated the maximum infant dose to be 4 mcg/kg daily based on the day 3 value.[3]

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

Effects in Breastfed Infants

The mother of a newborn was taking 5 to 10 mg of zolpidem nightly. At the one-month checkup, no adverse effects were noted by the patient’s pediatrician.[3]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Zaleplon

References

1.
Uguz F. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther. 2021;28:e118–e126. [PubMed: 30601177]
2.
Pons G, Francoual C, Guillet P, et al. Zolpidem excretion in breast milk. Eur J Clin Pharmacol. 1989;37:245–8. [PubMed: 2612539]
3.
Saito J, Tachibana Y, Sano Wada Y, et al. Presence of hypnotics in the cord blood and breast milk, with no adverse effects in the infant: A case report. Breastfeed Med. 2022;17:349–52. [PubMed: 34935466]

Substance Identification

Substance Name

Zolpidem

CAS Registry Number

82626-48-0

Drug Class

Breast Feeding

Lactation

Milk, Human

Hypnotics and Sedatives

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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