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Insomnia - Melatonin

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  • Insomnia - Melatonin

    I have a patient who is 10+4 WGA and has a long hx of insomnia for which the only successful intervention to date (including behavioral modification to include sleep hygiene and medication therapy) has been Melatonin. Based on the lack of data available to comment on its safety, I advised her against use in pregnancy. Two questions: (1) Do you concur? and (2) Are you are aware of any ongoing studies to investigate this further? Thank you!

  • #2

    InformationPregnancy QTAdvice
    The Use: Hormone
    Terato1: P3 – Unknown, risk to the fetus cannot be ruled out
    Terato2: P3 – Unknown, risk to the fetus cannot be ruled out
    T 1/2: 30-50 minutes
    Oral: Complete
    T Max: 0.5-2 hours
    Adult Dose:
    Trade Names:
    There are no controlled studies in pregnant women. In one animal study, administration of 10 mg/kg/d of melatonin, during pregnancy and 21 days postpartum, did not suggest an increase in adverse effect on rat pups (SHR rats); however, 50% and 95% of Wistar-Kyoto pups were lost at 3 weeks and 6 weeks postpartum respectively.[1] Author suggest that adverse effect to Wistar-Kyoto rat pups are species specific. Melatonin supplement can cross placental barrier and may alter reproductive development.[2] The safety of this drug in pregnancy has yet to be established and well-controlled studies need to be performed. It is therefore advised that pregnant women not take this drug if at all possible.

    1.## Singh HJ, Keah LS, Kumar A, Sirajudeen KN. Adverse effects of melatonin on rat pups of Wistar-Kyoto dams receiving melatonin supplementation during pregnancy. Exp Toxicol Pathol. 2011 Feb 25.
    2.## Melatonin. In: REPROTOX® Database [Internet database]. Greenwood Village, Colo: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed 07/05/2011.

    Sleep aides with more safety data would be preferred.

    Here are a few articles I found:



    Sandra Lovato R.N.
    InfantRisk Center


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