Is sleeping medication safe during pregnancy?

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Last updated: September 15, 2025View editorial policy

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Safety of Sleeping Medications During Pregnancy

Most sleeping medications are not considered safe during pregnancy and non-pharmacological approaches should be prioritized first for insomnia management in pregnant women.

Non-Pharmacological Approaches (First-Line)

  • Cognitive Behavioral Therapy (CBT) is the most evidence-based non-pharmacological treatment for insomnia during pregnancy 1
  • Sleep hygiene practices should be implemented:
    • Maintaining consistent sleep schedule
    • Creating a comfortable sleep environment
    • Avoiding caffeine and screen time before bed
    • Using relaxation techniques
  • Nutrition optimization is particularly important in the perinatal period 1
  • Mindfulness and yoga have shown preliminary support for improving sleep during pregnancy 2
  • Relaxation techniques may be beneficial for pregnancy-related insomnia 2

Pharmacological Options (Second-Line)

When non-pharmacological approaches are insufficient, medication should be considered only after careful risk-benefit assessment:

FDA-Labeled Warnings for Common Sleep Aids

  1. Diphenhydramine (Benadryl):

    • FDA label explicitly states: "If pregnant or breast-feeding, ask a healthcare professional before use" 3
    • May cause drowsiness and should be used with caution
  2. Doxylamine:

    • FDA label states: "If pregnant or breast-feeding, ask a health professional before use" 4
    • Limited safety data during pregnancy
  3. Prescription Sleep Medications:

    • Sodium oxybate: "Based on animal data, sodium oxybate may cause fetal harm. Human data are insufficient to determine risk" 5
    • Z-drugs (zolpidem, etc.): Limited data on safety during pregnancy, with inconclusive evidence regarding potential adverse effects 6

Risk Assessment and Decision-Making

The American Academy of Sleep Medicine guidelines note that "the scope of the literature review did not include data to make specific recommendations for pregnant and lactating women" 5, highlighting the limited evidence in this population.

When considering medication:

  1. Weigh the risks of untreated insomnia (which can include pregnancy complications, preterm birth, and postpartum depression) against potential medication risks
  2. Consider intermittent use rather than continuous use when possible
  3. Use the lowest effective dose for the shortest duration
  4. Monitor closely for adverse effects

Important Caveats

  • Sleep disturbances are common during pregnancy and may be related to normal physiological changes 7
  • Insomnia may be a symptom of an underlying condition such as anxiety, depression, sleep-disordered breathing, or restless legs syndrome that should be addressed 7
  • The risks of pharmacotherapy must be carefully weighed against benefits due to potential teratogenicity with some medications 7
  • There is an urgent need for high-quality randomized controlled trials of insomnia interventions during pregnancy 2

When sleep problems persist despite non-pharmacological interventions, consultation with a specialist in reproductive psychiatry or maternal-fetal medicine is recommended to develop an individualized treatment plan that minimizes risks to both mother and fetus.

References

Guideline

Postpartum Mood Disorder Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

How do you Zzz during pregnancy? A brief review of Z-drug use and management of insomnia during pregnancy.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2025

Research

Insomnia during pregnancy: Diagnosis and Rational Interventions.

Pakistan journal of medical sciences, 2016

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.

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