Efficacy on sleep parameters and tolerability of melatonin in individuals with sleep or mental disorders: A systematic review and meta-analysis

Salanitro et al., 2022 | Neurosci Biobehav Rev | Meta Analysis

Citation

Salanitro Matthew, Wrigley Torsten, ... Cortese Samuele. Efficacy on sleep parameters and tolerability of melatonin in individuals with sleep or mental disorders: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2022-Aug;139:104723. doi:10.1016/j.neubiorev.2022.104723

Abstract

We conducted the first systematic review and series of meta-analyses to assess the efficacy and tolerability of melatonin in children/adolescents or adults with sleep or mental health disorders, using the same set of criteria across disorders and ages. Based on a pre-registered protocol (PROPSPERO: CRD42021289827), we searched a broad range of electronic databases up to 02.02.2021 for randomized control trials (RCTs) of melatonin. We assessed study quality using the Risk of Bias tool, v2. We included a total of 34 RCTs (21 in children/adolescents: N = 984; 13 in adults: N = 1014). We found evidence that melatonin significantly improved sleep onset latency and total sleep time, but not sleep awaking, in children and adolescents with a variety of neurodevelopmental disorders, and sleep onset latency (measured by diary) as well as total sleep time (measured with polysomnography) in adults with delayed sleep phase disorder. No evidence of significant differences between melatonin and placebo was found in terms of tolerability. We discuss clinical and research implications of our findings.

Key Findings

We discuss clinical and research implications of our findings.

Outcomes Measured

  • sleep onset latency

Population

Field Value
Population See abstract
Sample Size 984
Age Range See abstract
Condition sleep

MeSH Terms

  • Adolescent
  • Child
  • Humans
  • Melatonin
  • Neurodevelopmental Disorders
  • Sleep
  • Sleep Wake Disorders

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Systematic Review
  • Vertical: melatonin

Provenance


Source extracted via PubMed E-utilities API on 2026-04-09