Safety of higher doses of melatonin in adults: A systematic review and meta‐analysis
Menczel Schrire et al.,
Safety of higher doses of melatonin in adults: A systematic review and meta‐analysis,
Journal of Pineal Research, doi:10.1111/jpi.12782
Safety analysis of 79 high-dose melatonin studies, finding that ≥10mg melatonin did not increase the frequency of SAEs across a range of clinical conditions.
Menczel Schrire et al., 19 Dec 2021, peer-reviewed, 15 authors.
Contact:
camilla.hoyos@sydney.edu.au.
Abstract: DOI: 10.1111/jpi.12782
| Revised: 14 December 2021 | Accepted: 14 December 2021
REVIEW
Safety of higher doses of melatonin in adults: A systematic
review and meta-analysis
Zoe Menczel Schrire1,2,3,4
| Craig L. Phillips4,5 | Julia L. Chapman1,2,3,4 |
Shantel L. Duffy2,3,4,5 | Grace Wong4 | Angela L. D’Rozario1,2,3,4 | Maria Comas4
Isabelle Raisin6 | Bandana Saini4,5 | Christopher J. Gordon4,5 |
Andrew C. McKinnon1,2,3 | Sharon L. Naismith1,2,3 | Nathaniel S. Marshall4,5 |
Ronald R. Grunstein4,5,7 | Camilla M. Hoyos1,2,3,4
|
1
Healthy Brain Ageing Program, Faculty of Science, School of Psychology, The University of Sydney, Sydney, New South Wales, Australia
2
Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia
3
Brain & Mind Centre, The University of Sydney, Sydney, New South Wales, Australia
4
Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, University of Sydney, Sydney, New South Wales, Australia
5
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
6
University Library, The University of Sydney, Sydney, New South Wales, Australia
7
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Correspondence
Camilla M. Hoyos, Charles Perkins
Centre, The University of Sydney, Level
2, Building D17, Johns Hopkins Drive,
Camperdown, NSW 2050, Australia.
Email: camilla.hoyos@sydney.edu.au
Funding information
CMH and ALD are funded by an
NHMRC-ARC Dementia Research
Development Fellowship (APP1104003
and GTN1107716 respectively). ZMS
is funded by the Centre of Research
Excellence to Optimise Sleep in
Brain Ageing and Neurodegeneration
(CogSleep CRE) Scholarship. RRG is
principally funded by the Australian
National Health and Medical Research
Council (NHMRC) via a Project
Grant (GTN1004528), NHMRC
Senior Principal Research Fellowship
GTN1152945, RRG), NHMRC
Centre for Research Excellence and
NeuroSLEEP (GTN1060992, RRG).
SLN and CLP are funded by NHMRC
Boosting Dementia Leadership
Fellowships (SLN GTN1135639, CLP
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..
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