What sleep medicines are safe to use while breastfeeding?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: July 31, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Safe Sleep Medicines for Breastfeeding Mothers

Short-acting benzodiazepines like midazolam and non-sedating analgesics like paracetamol (acetaminophen) are the safest sleep aids for breastfeeding mothers, while diphenhydramine and doxylamine should be used with caution, and tramadol and oxycodone require careful monitoring of the infant for drowsiness. 1, 2

First-Line Options for Sleep in Breastfeeding Mothers

Non-Pharmacological Approaches (Preferred)

  • Improve sleep hygiene practices
  • Maintain consistent sleep schedule
  • Create a comfortable sleep environment
  • Practice relaxation techniques before bedtime
  • Consider room-sharing without bed-sharing with infant 2

Safe Pharmacological Options

  1. Midazolam (short-acting benzodiazepine)

    • Extensive first-pass metabolism results in low systemic bioavailability
    • Blood levels in infant after breastfeeding expected to be low
    • Breastfeeding can be resumed after a single dose as soon as mother has recovered 1
  2. Paracetamol/Acetaminophen

    • Amount transferred to breast milk is significantly less than pediatric therapeutic dose
    • Has been used extensively during lactation
    • Safe for both short-term and long-term use 1

Second-Line Options (Use with Caution)

  1. Diphenhydramine (Benadryl)

    • FDA label warns to consult healthcare professional before use while breastfeeding
    • Can cause marked drowsiness in mother
    • May cause infant irritability or sedation
    • Avoid alcohol and other sedatives when using 3
  2. Doxylamine

    • FDA label recommends consulting healthcare professional before use
    • Take only at bedtime
    • Avoid alcoholic beverages 4
  3. Melatonin

    • Limited but growing evidence suggests probable safety during breastfeeding
    • Clinical studies to date have not suggested major safety concerns
    • More research needed specifically for sleep disorders 5

Medications to Use with Extra Caution

  1. Diazepam (Valium)

    • Has active metabolite (desmethyl-diazepam) with prolonged half-life
    • Known to be transferred in breast milk in significant levels
    • Consider only as one-off dose before a procedure
    • Not recommended for regular use as sleep aid 1
  2. Tramadol

    • Observe infant for unusual drowsiness
    • FDA warning against use while breastfeeding, though UK guidelines allow cautious use
    • Restrict to inpatient use and limit total dose 1
  3. Oxycodone

    • Greater risk of drowsiness in doses > 40 mg/day
    • Multiple reports of sedation, respiratory depression, and feeding difficulties in infants
    • Avoid repeated dosing 1

Important Safety Precautions

  • Never co-sleep with infant after taking any sedative medication - significantly increases SIDS risk 2
  • Monitor infant for signs of:
    • Unusual drowsiness
    • Poor feeding
    • Respiratory depression
    • Decreased alertness 1, 2
  • If mother falls asleep while breastfeeding after taking sleep medication, infant should be placed on separate sleep surface immediately upon waking 2
  • Avoid alcohol consumption during breastfeeding - increases SIDS risk and may impair maternal alertness 2

Clinical Decision Algorithm

  1. First attempt non-pharmacological approaches
  2. If medication needed:
    • For occasional use: Midazolam (single dose) or paracetamol
    • For short-term use with minimal sedation: Melatonin (with caution)
    • For antihistamine effect with sleep benefit: Diphenhydramine (with monitoring)
  3. Avoid or use extreme caution with:
    • Long-acting benzodiazepines
    • Opioids (especially repeated doses)
    • Any medication combined with alcohol

Common Pitfalls to Avoid

  • Overly restrictive advice - most medications can be used safely during breastfeeding at recommended doses 6, 7
  • Unnecessarily discontinuing breastfeeding - medication use is one of the most common reasons for cessation of breastfeeding 7
  • Failing to monitor infant - always observe for signs of sedation after using any potentially sedating medication 1
  • Bed-sharing after sedative use - significantly increases risk of SIDS 2
  • Assuming all medications in a class have similar safety profiles - individual drugs within classes may have different safety profiles 8

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Sleep Management for Breastfeeding Mothers

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Melatonin use during pregnancy and lactation: A scoping review of human studies.

Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999), 2022

Research

Drugs and breastfeeding: instructions for use.

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2012

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.