P076 Safety of higher doses of melatonin in adults: A systematic review and meta-analysis. (9th November 2022)

• Record Type: Journal Article
• Authors: Menczel Schrire, Z; Phillips, C; Gordon, C; Naismith, S; Marshall, N; Grunstein, R
• Is Part Of: Sleep advances. Volume 3(2022)Supplement 1
• Page Start: A54
• Page End: A55
• Publication Date: 2022-11-09
• Subjects: Sleep disorders -- Periodicals; Circadian rhythms -- Periodicals; 616.8498
• DOI: 10.1093/sleepadvances/zpac029.146
• Languages: English
• ISSNs: 2632-5012

Abstract

Abstract: Introduction: Melatonin is commonly used for sleep and jetlag at low doses. There is less documentation on the safety of higher doses which are being increasingly used for a wide variety of conditions. This systematic review aimed to investigate the safety of higher doses of melatonin in adults. Methods: We searched Medline, Scopus, Embase and PsycINFO databases from study inception until December 2019 with convenience searches until October 2020. The inclusion criteria were randomised controlled trials investigating high-dose melatonin (≥10mg) in human adults over 30 years of age. The outcomes examined were the number of adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs. A meta-analysis was conducted on studies lasting 3 months or longer. Results: 79 studies were identified with a total of 3861 participants. 29 studies (37%) made no mention of the presence or absence of AEs. Only 4 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=0.64) or withdrawals due to AEs (0.93 [0.24, 3.56], p=0.92), but did appear to increase the risk of AEs such as drowsiness, headache, and dizziness (1.40, [1.15, 1.69], p<0.001). Discussion: 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.