The Safety of Melatonin in Humans.
Level 5 - mechanism / opinion, no new human data
Narrative review synthesizing published animal and human data without reported systematic review protocol.
PubMed 26692007 · doi:10.1007/s40261-015-0368-5
What was done
The authors reviewed the published literature evaluating the safety, potential adverse effects, and risk profiles of exogenous melatonin administration in humans and animals, including specific patient subgroups.
What was found
The abstract reports no numerical values or counts. Qualitatively, short-term melatonin was reported safe even at extreme doses, with only mild adverse events identified (dizziness, headache, nausea, and sleepiness) and no serious adverse effects. Randomized trials of long-term use indicated adverse effects were mild and comparable to placebo. Human safety data are lacking for pregnant and breast-feeding populations, and long-term data in children and adolescents remain incomplete.
Why it matters
This paper consolidates broad clinical evidence on melatonin tolerability, confirming general adult safety while emphasizing caution and evidence gaps for pediatric and maternal use.
Limits
The abstract provides no sample size, search methodology, dosing parameters, or quantitative effect sizes. As a narrative review, it is vulnerable to selection bias, and human evidence is absent for pregnancy and lactation.
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