Is melatonin safe during pregnancy?

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Last updated: April 7, 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, due to the lack of rigorous safety testing and potential interference with fetal development. The use of melatonin during pregnancy is not well-studied, and its effects on the fetus are not fully understood 1. As a dietary supplement, melatonin is not subject to the same level of safety testing as medications, which raises concerns about its use during pregnancy.

When considering the management of sleep disorders during pregnancy, it is essential to prioritize the safety of both the mother and the fetus. The American Academy of Sleep Medicine recommends that sedatives/hypnotics, including melatonin receptor agonists, should not be used during pregnancy or nursing 1. Instead, natural approaches to improving sleep, such as establishing a consistent sleep schedule, creating a comfortable sleep environment, and practicing relaxation techniques, should be tried first.

If sleep problems persist, consultation with an obstetrician or midwife is necessary to discuss pregnancy-safe alternatives. The potential risks associated with melatonin use during pregnancy, including the possibility of disrupting the delicate balance of hormones during pregnancy, must be carefully weighed against any potential benefits 1. In general, the principle of caution should guide decision-making regarding the use of any supplement or medication during pregnancy, prioritizing the well-being and safety of both the mother and the fetus.

From the Research

Melatonin Safety 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 and breastfeeding is probably safe in humans 2.
  • Clinical trials that used exogenous melatonin during pregnancy and breastfeeding for other clinical conditions have not suggested major safety concerns or adverse events 2.
  • There is a lack of randomized, controlled trials examining the efficacy and safety of melatonin as a treatment for sleep disorders during pregnancy or breastfeeding 2.

Comparison with Other Sleep Disorder Treatments

  • Melatonin has been shown to be well tolerated and have no obvious short- or long-term adverse effects, making it a potential alternative to other pharmaceutical therapies for sleep disorders 3.
  • Other medications commonly used to treat insomnia during pregnancy, such as benzodiazepines and sedative-hypnotics, have the potential for dependence and addiction 4.
  • Melatonin has been shown to synchronize circadian rhythms, improve sleep onset, duration, and quality, and has anti-oxidation and neuronal survival properties 3.

Gynecological Practice and Sleep Disruption

  • Sleep disruption is a common symptom in gynecological diseases, including menstrual cycle related disorders, endometriosis, and peri- and postmenopausal symptoms 5.
  • Doxylamine and melatonin have been considered as treatment options for sleep disruption in gynecological practice, although more research is needed to fully understand their efficacy and safety in this context 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

A review of sleep disorders and melatonin.

Neurological research, 2017

Research

[Doxylamine and melatonin in treatment of sleep disruption in gynecological practice].

Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2018

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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