What sleep medications are safe for use during pregnancy?

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Last updated: October 29, 2025View editorial policy

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Safe Sleep Medications During Pregnancy

Non-pharmacological approaches should be the first-line treatment for sleep disorders during pregnancy due to potential risks associated with medications to the developing fetus.

First-Line Approach: Non-Pharmacological Interventions

  • Implement sleep hygiene measures as the primary treatment strategy, including maintaining a regular sleep schedule, creating a comfortable sleep environment, avoiding heavy meals near bedtime, and limiting screen exposure before sleep 1
  • Engage in regular physical activity to improve sleep quality during pregnancy 1
  • Consider cognitive behavioral therapy (CBT) for sleep disturbances, which has shown effectiveness without medication risks 1
  • Use relaxation techniques and mind-body interventions such as mindfulness meditation to improve sleep 1

Pharmacological Options (When Non-Pharmacological Approaches Fail)

Relatively Safer Options

  • Doxylamine may be used with caution for short-term insomnia:

    • FDA labeling indicates pregnant women should consult a healthcare professional before use 2
    • Should only be used when benefits outweigh potential risks 2
  • Diphenhydramine may be considered with caution:

    • FDA labeling requires pregnant women to consult a healthcare professional before use 3
    • Marked drowsiness may occur, and caution is advised when driving or operating machinery 3
  • Sertraline may be considered for sleep disturbances associated with depression:

    • One of the preferred antidepressants during pregnancy due to its favorable safety profile 1
    • Should be used at the lowest effective dose with close monitoring 1
    • Arrange early follow-up after hospital discharge for infants exposed in the third trimester to monitor for neonatal adaptation syndrome 1

Medications to Avoid During Pregnancy

  • Sodium oxybate has insufficient safety data for use during pregnancy and may cause fetal harm based on animal data 1, 4
  • Pitolisant may cause fetal harm based on animal data and may reduce the effectiveness of oral contraceptives 1, 4
  • Methylphenidate may cause fetal harm based on animal data 1, 4
  • Modafinil/armodafinil may cause fetal harm based on animal data and may reduce the effectiveness of hormonal contraception 5, 1

Special Considerations

  • Sleep disturbances are common during pregnancy, affecting more than half of all pregnancies and increasing as gestation progresses 6
  • Sleep disruption in pregnancy can substantially worsen maternal quality of life and may be a risk factor for adverse pregnancy outcomes 6
  • For pregnant women with pre-existing sleep disorders, a multidisciplinary approach involving maternal-fetal medicine specialists is beneficial 1
  • The risks of pharmacotherapy must be weighed against their benefits due to the possible risk of teratogenicity associated with some medications 7

Common Pitfalls and Caveats

  • Sleep disturbances are often dismissed as normal during pregnancy, which may impede accurate diagnosis of treatable sleep disorders 6
  • Limited research exists on sleep medications during pregnancy, making definitive recommendations difficult 5
  • SSRIs in the third trimester may be associated with neonatal adaptation syndrome, including irritability, tremors, feeding difficulties, and respiratory distress 1
  • When considering any medication during pregnancy, the risk of the untreated condition must be weighed against the risk of medication exposure 8

References

Guideline

Safe Sleep Medications During Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Treatment Options for Narcolepsy in Breastfeeding Women

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Common Sleep Disorders in Pregnancy.

Obstetrics and gynecology, 2022

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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