Effects of exogenous melatonin on sleep: a meta-analysis

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#cross-over-studies #dose-response-relationship-drug #drug-administration-schedule #humans #melatonin

Effects of exogenous melatonin on sleep: a meta-analysis

Brzezinski et al., 2005 | Sleep Med Rev | Meta Analysis

Citation

Brzezinski Amnon, Vangel Mark G, ... Ford Ian. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005-Feb;9(1):41-50

Abstract

Exogenous melatonin reportedly induces drowsiness and sleep, and may ameliorate sleep disturbances, including the nocturnal awakenings associated with old age. However, existing studies on the soporific efficacy of melatonin have been highly heterogeneous in regard to inclusion and exclusion criteria, measures to evaluate insomnia, doses of the medication, and routes of administration. We reviewed and analyzed (by meta-analysis) available information on effects of exogenous melatonin on sleep. A MEDLINE search (1980 to December 2003) provided English-language articles, supplemented by personal files maintained by the authors. The analysis used information derived from 17 different studies (involving 284 subjects) that satisfied inclusion criteria. Sleep onset latency, total sleep duration, and sleep efficiency were selected as the outcome measures. The study effect size was taken to be the difference between the response on placebo and the mean response on melatonin for each outcome measured. Melatonin treatment significantly reduced sleep onset latency by 4.0 min (95% CI 2.5, 5.4); increased sleep efficiency by 2.2% (95% CI 0.2, 4.2), and increased total sleep duration by 12.8 min (95% CI 2.9, 22.8). Since 15 of the 17 studies enrolled healthy subjects or people with no relevant medical condition other than insomnia, the analysis was also done including only these 15 studies. The sleep onset results were changed to 3.9 min (95% CI (2.5, 5.4)); sleep efficiency increased to 3.1% (95% CI (0.7, 5.5)); sleep duration increased to 13.7 min (95% CI (3.1, 24.3)).

Key Findings

The sleep onset results were changed to 3.9 min (95% CI (2.5, 5.4)); sleep efficiency increased to 3.1% (95% CI (0.7, 5.5)); sleep duration increased to 13.7 min (95% CI (3.1, 24.3)).

Outcomes Measured

  • sleep onset latency
  • sleep duration
  • sleep efficiency

Population

Field Value
Population See abstract
Sample Size 284
Age Range See abstract
Condition insomnia

MeSH Terms

  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Humans
  • Melatonin
  • Randomized Controlled Trials as Topic
  • Reference Values
  • Sleep
  • Sleep Disorders, Circadian Rhythm
  • Sleep Initiation and Maintenance Disorders
  • Treatment Outcome

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.
  • Vertical: melatonin

Provenance

  • PMID: 15649737
  • DOI: (not available)
  • PMCID: Not in PMC
  • Verified: 2026-04-09 via PubMed E-utilities API

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