Cited by 133Circadian rhythm and melatoninSleep and related disordersPharmacovigilance and Adverse Drug Reactions

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Safety of higher doses of melatonin in adults: A systematic review and meta-analysis

Menczel Schrire, Zoe, Phillips, Craig L., Chapman, Julia L., Duffy, Shantel L., Wong, Grace, D’Rozario, Angela L., Comas, Maria, Raisin, Isabelle, Saini, Bandana, Gordon, Christopher J., McKinnon, Andrew C., Naismith, Sharon L., Marshall, Nathaniel S., Grunstein, Ronald R., Hoyos, Camilla M.·2022·Journal of Pineal Research

DOI 10.1111/jpi.12782

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Abstract

Melatonin is commonly used for sleep and jetlag at low doses. However, there is less documentation on the safety of higher doses, which are being increasingly used for a wide variety of conditions, including more recently COVID-19 prevention and treatment. The aim of this review was to investigate the safety of higher doses of melatonin in adults. Medline, Scopus, Embase and PsycINFO databases from inception until December 2019 with convenience searches until October 2020. Randomised controlled trials investigating high-dose melatonin (≥10 mg) in human adults over 30 years of age were included. Two investigators independently abstracted articles using PRISMA guidelines. Risk of bias was assessed by a committee of three investigators. 79 studies were identified with a total of 3861 participants. Studies included a large range of medical conditions. The meta-analysis was pooled data using a random effects model. The outcomes examined were the number of adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs. A total of 29 studies (37%) made no mention of the presence or absence of AEs. Overall, only four studies met the pre-specified low risk of bias criteria for meta-analysis. In that small subset, melatonin did not cause a detectable increase in SAEs (Rate Ratio = 0.88 [0.52, 1.50], p = .64) or withdrawals due to AEs (0.93 [0.24, 3.56], p = .92), but did appear to increase the risk of AEs such as drowsiness, headache and dizziness (1.40 [1.15, 1.69], p < .001). Overall, there has been limited AE reporting from high-dose melatonin studies. Based on this limited evidence, melatonin appears to have a good safety profile. Better safety reporting in future long-term trials is needed to confirm this as our confidence limits were very wide due to the paucity of suitable data.

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Authors: Menczel Schrire, Z., Phillips, C. L., Chapman, J. L., Duffy, S. L., Wong, G., D’Rozario, A. L., Comas, M., Raisin, I., Saini, B., Gordon, C. J., McKinnon, A. C., Naismith, S. L., Marshall, N. S., Grunstein, R. R., & Hoyos, C. M.
Affiliations: Healthy Brain Ageing Program Faculty of Science School of Psychology The University of Sydney Sydney New South Wales Australia
The University of Sydney (AU)
Corresponding author: Hoyos, Camilla M.
ORCID: Menczel Schrire, Zoe
Phillips, Craig L.
Chapman, Julia L.
Duffy, Shantel L.
Comas, Maria
Raisin, Isabelle
Saini, Bandana
Gordon, Christopher J.
McKinnon, Andrew C.
Naismith, Sharon L.
Marshall, Nathaniel S.
Grunstein, Ronald R.
Hoyos, Camilla M.
Venue: Journal of Pineal Research
Publisher: Wiley
Published: 2021-12-30
Volume: 72
Issue: 2
Pages: e12782-e12782
ISSN: 0742-3098 (ISSN-L)
1600-079X
DOI: 10.1111/jpi.12782
OpenAlex: W4200605156
Cited by: 133
References: 88
Citations by year: 2026: 27 · 2025: 29 · 2024: 33 · 2023: 26 · 2022: 18
FWCI: 2.46
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Journal of Pineal Research (publishedVersion)
PubMed (publishedVersion)
The Sydney eScholarship Repository (The University of Sydney) (submittedVersion)
Funders: National Health and Medical Research Council
University of Sydney
Topics: Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: melatonin, drug safety, adverse events, serious adverse events, adults, sleepiness, headache, dizziness, jet lag, COVID-19 pandemic
MeSH terms: COVID-19, SARS-CoV-2, Adult, Humans, Melatonin, Sleep

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Safety of higher doses of melatonin in adults: A systematic review and meta-analysis

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