The DOI matches its Crossref record; 104 of the 107 references it cites were found in a registry or an index.
Adverse events associated with oral administration of melatonin: A critical systematic review of clinical evidence
Abstract
While melatonin was once thought of simply as a sleep-inducing hormone, recent research has resulted in development of a deeper understanding of the complex physiological activity of melatonin in the human body. Along with this understanding has come widespread, increasing use of melatonin supplementation, extending beyond its traditional use as a sleep aid into novel fields of application. This increased use often involves off-label and self-prescription, escalating the importance of safety data. In order to examine the current knowledge relating to safety of the exogenous neurohormone, we conducted a comprehensive, critical systematic review of clinical evidence. We examined controlled studies of oral melatonin supplementation in humans when they presented any statistical analysis of adverse events. Of the fifty articles identified, twenty-six found no statistically significant adverse events, while twenty-four articles reported on at least one statistically significant adverse event. Adverse events were generally minor, short-lived and easily managed, with the most commonly reported adverse events relating to fatigue, mood, or psychomotor and neurocognitive performance. A few studies noted adverse events relating to endocrine (e.g. reproductive parameters, glucose metabolism) and cardiovascular (e.g. blood pressure, heart rate) function, which appear to be influenced by dosage, dose timing and potential interactions with antihypertensive drugs. Oral melatonin supplementation in humans has a generally favourable safety profile with some exceptions. Most adverse effects can likely be easily avoided or managed by dosing in accordance with natural circadian rhythms. Further research is required to explore the potential for melatonin to interact with endogenous hormones and pharmaceuticals.
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“Oral melatonin is mostly perceived as safe based on published reports, even in higher doses [300]; however, there can be specific instances that may necessitate further diligence and clinical oversight.”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [300]
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BackgroundInfluentialMelatonin’s role in redox homeostasis: A preclinical and clinical perspective
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Metadata
- Authors
- Foley, H. M., & Steel, A. E.
- Affiliations
- Endeavour College of Natural Health (AU)
- Corresponding author
- Foley, Hope M.
- Venue
- Complementary Therapies in Medicine
- Publisher
- Elsevier BV
- Published
- 2019-02
- Volume
- 42
- Pages
- 65-81
- ISSN
- 0965-2299 (ISSN-L)
- OpenAlex
- W2898688630
- Cited by
- 144
- References
- 107
- Citations by year
- 2026: 11 · 2025: 22 · 2024: 21 · 2023: 17 · 2022: 20 · 2021: 25 · 2020: 20 · 2019: 8
- FWCI
- 1.85
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Complementary Therapies in Medicine (publishedVersion)
- PubMed (publishedVersion)
- OPUS - Open Publications of UTS Scholars (University of Technology Sydney) (submittedVersion)
- Funders
- Complementary Medicines Australia
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Keywords
- melatonin, oral supplementation, adverse events, drug safety, sleep aids, off-label drug use, self-prescription, fatigue, mood, neuropsychological performance, cardiovascular effects, glucose metabolism, reproductive parameters, antihypertensive drug interactions, endocrine interactions
- MeSH terms
- Administration, Oral, Animals, Humans, Melatonin, Drug-Related Side Effects and Adverse Reactions
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