Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review

Background Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been licensed in the UK for the short-term treatment of jetlag. Little is known about the potential for adverse events (AEs),...

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Bibliographic Details
Published in:CNS drugs 2019-12, Vol.33 (12), p.1167-1186
Main Authors: Besag, Frank M. C., Vasey, Michael J., Lao, Kim S. J., Wong, Ian C. K.
Format: Article
Language:English
Subjects:
Asthma
Bias
Chronic illnesses
Clinical trials
Dietary supplements
Drug dosages
Epilepsy
Headache
Hypothermia
Infants
Insomnia
Irritation
Licenses
Medicine
Medicine & Public Health
Melatonin
Mood
Neurology
Neurosciences
Patients
Pharmacotherapy
Population studies
Psychiatry
Psychopharmacology
Regulation
Regulatory approval
Short term
Sleep
Sleep and wakefulness
Sleep disorders
Systematic Review
Teenagers
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Summary:Background Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been licensed in the UK for the short-term treatment of jetlag. Little is known about the potential for adverse events (AEs), in particular AEs resulting from long-term use. Concern has been raised over the possible risks of exposure in certain populations including pre-adolescent children and patients with epilepsy or asthma. Objectives The aim of this systematic review was to assess the evidence for AEs associated with short-term and longer-term melatonin treatment for sleep disorders. Methods A literature search of the PubMed/Medline database and Google Scholar was conducted to identify randomised, placebo-controlled trials (RCTs) of exogenous melatonin administered for primary or secondary sleep disorders. Studies were included if they reported on both the types and frequencies of AEs. Studies of pre-term infants, studies of 
ISSN:1172-7047
1179-1934
DOI:10.1007/s40263-019-00680-w