Is melatonin (N-acetyl-5-methoxytryptamine) safe for use during pregnancy?

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Last updated: April 24, 2025View editorial policy

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From the Guidelines

Melatonin should not be used during pregnancy unless absolutely necessary and under the guidance of a healthcare provider. The use of melatonin during pregnancy is a concern due to its potential effects on fetal development and the timing of labor, as it naturally crosses the placenta and plays important roles in these processes 1. There is limited research on the safety of melatonin during pregnancy, and no established safe dosage exists for pregnant women.

Key Considerations

  • The potential risks to fetal development are not fully understood, making it crucial to exercise caution.
  • Non-medication approaches should be tried first to manage sleep difficulties during pregnancy, such as maintaining a consistent sleep schedule and creating a comfortable sleep environment.
  • If sleep problems significantly affect health during pregnancy, consultation with an obstetrician or healthcare provider is necessary to evaluate the specific situation and recommend appropriate interventions.

Safety and Efficacy

The study from the Journal of Clinical Sleep Medicine 1 provides guidance on the use of various sleep medications but does not specifically recommend melatonin for use during pregnancy. Instead, it advises caution with the use of sedatives/hypnotics, including considerations for pregnancy and nursing, where these medications are generally not recommended.

Clinical Decision Making

Given the lack of clear evidence supporting the safe use of melatonin during pregnancy and the potential for disrupting fetal development, the safest approach is to avoid melatonin unless a healthcare provider advises its use based on a thorough evaluation of the benefits and risks. This decision prioritizes the health and safety of both the mother and the fetus, aligning with the principles of minimizing morbidity, mortality, and optimizing quality of life.

From the Research

Melatonin Use in Pregnancy

  • The use of exogenous melatonin in pregnant populations is quite common, with a prevalence of around 4% 2.
  • Contrary to animal studies, evidence from clinical studies suggests that melatonin use during pregnancy is probably safe in humans 2.
  • Clinical trials that used exogenous melatonin during pregnancy for other clinical conditions have not suggested major safety concerns or adverse events 2.

Alternative Treatments for Insomnia in Pregnancy

  • Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective nonpharmacologic treatment for insomnia during pregnancy 3.
  • CBT-I has been found to improve insomnia severity and sleep quality in pregnant women, with significant reductions in insomnia symptoms and increases in subjective sleep quality 3, 4.
  • CBT-I has also been found to reduce symptoms of depression, pregnancy-specific anxiety, and fatigue in pregnant women 4.

Melatonin's Role in Human Pregnancy

  • Melatonin is a neuroendocrine hormone that regulates biological rhythms and has been found to play a role in human pregnancy 5.
  • Melatonin crosses the placenta freely and provides photoperiodic information to the fetus, and has been found to be essential for successful pregnancy 5.
  • Melatonin has also been found to be involved in correcting the pathophysiology of complications during pregnancy, including abortion, pre-eclampsia, and fetal brain damage 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

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

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

Research

Melatonin and pregnancy in the human.

Reproductive toxicology (Elmsford, N.Y.), 2008

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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