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

The DOI matches its Crossref record; 88 of the 88 references it cites were found in a registry or an index.

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
Open this paper in CoChat — free account

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.

Overview

Integrity signals

Registry

Crossref · 10.1111/jpi.12782

Cites

88 of 88 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

1 retracted

Cited by

Sorted by citations

See all 133

Related

See all

Metadata

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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review