Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Appendix F: Melatonin: Prototype Monograph Summary
Appendix F: Melatonin: Prototype Monograph Summary
Pages 367-371
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From page 367... ...
Thus some pertinent information not available to the Committee could be of importance in evaluating safety to determine if use of this dietary supplement ingredient would present an unreasonable risk of illness or injury. Also, the development and review of this prototype was conducted by individuals whose backgrounds are in general aspects of evaluating science and whose expertise is not necessarily focused specifically on this dietary ingredient, although significant additional assistance was provided by consultants with relevant expertise.
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From page 368... ...
Moreover, there is insufficient information on interactions of melatonin with drugs or other dietary supplements. Most available studies were conducted with adults, and little information is available for infants and young children regarding adverse effects, specifically concerning possible melatonin-induced alterations of pubertal development.
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From page 369... ...
Use of melatonin in populations other than healthy adults increases the level of concern based in part on the observation that serious adverse effects reported at 10 mg or less of melatonin per day generally occurred in humans with preexisting medical or psychological conditions that may have contributed to the ill effects. Specifically, concern of harm exists for individuals with one or more of the following: (1)
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From page 370... ...
· Many of the available studies in humans included small numbers of participants and varied greatly in duration of treatment, from a single dose to dosing for a few weeks or months. · Few investigators described systematic collection of adverse effects in clinical trials.
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From page 371... ...
J Neural Transm Suppl 21:81108. Valcavi R, Dieguez C, Azzarito C, Edwards CA, Dotti C, Page MD, Portioli I, Scanlon MF.
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