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The Safety of Melatonin in Humans

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Abstract

Exogenous melatonin has been investigated as treatment for a number of medical and surgical diseases, demonstrating encouraging results. The aim of this review was to present and evaluate the literature concerning the possible adverse effects and safety of exogenous melatonin in humans. Furthermore, we provide recommendations concerning the possible risks of melatonin use in specific patient groups. In general, animal and human studies documented that short-term use of melatonin is safe, even in extreme doses. Only mild adverse effects, such as dizziness, headache, nausea and sleepiness have been reported. No studies have indicated that exogenous melatonin should induce any serious adverse effects. Similarly, randomized clinical studies indicate that long-term melatonin treatment causes only mild adverse effects comparable to placebo. Long-term safety of melatonin in children and adolescents, however, requires further investigation. Due to a lack of human studies, pregnant and breast-feeding women should not take exogenous melatonin at this moment.

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Authors and Affiliations

  1. Department of Surgery, Herlev Hospital, University of Copenhagen, 2730, Herlev, Denmark

    Lars Peter Holst Andersen & Jacob Rosenberg

  2. Department of Surgery, Roskilde and Køge Hospital, University of Copenhagen, Roskilde, Denmark

    Ismail Gögenur

  3. Department of Cellular and Structural Biology, UT Health Science Center, San Antonio, TX, USA

    Russel J. Reiter

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  1. Lars Peter Holst Andersen
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  2. Ismail Gögenur
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Correspondence to Lars Peter Holst Andersen.

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LPHA, IG, JR and RJR do not have any conflicts of interest to declare.

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Andersen, L.P.H., Gögenur, I., Rosenberg, J. et al. The Safety of Melatonin in Humans. Clin Drug Investig 36, 169–175 (2016). https://doi.org/10.1007/s40261-015-0368-5

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