Melatonin for preventing primary headache: A systematic review

source extracted confidence: high 2026-04-09
#acetaminophen #analgesics #aspirin #central-nervous-system-depressants #humans

Melatonin for preventing primary headache: A systematic review

Leite et al., 2018 | Int J Clin Pract | Systematic Review

Citation

Leite Pacheco Rafael, de Oliveira Cruz Latorraca Carolina, ... Riera Rachel. Melatonin for preventing primary headache: A systematic review. Int J Clin Pract. 2018-Jul;72(7):e13203. doi:10.1111/ijcp.13203

Abstract

BACKGROUND: The aim of this study was to assess the effectiveness and safety of melatonin for primary headache. METHODS: This systematic review following the Cochrane Handbook for Systematic Reviews of Interventions recommendations and PRISMA Statement. RESULTS: Four randomized controlled trials were included (351 participants). According to the GRADE approach the quality of evidence was very low. The use of melatonin for migraine showed that (i) reduced the number of days with pain and the analgesic consumption when compared with placebo, (ii) no benefits on headache intensity, number of headache days and analgesics consumption when compared with amitriptyline, (iii) reduced the number of analgesic consumption, the attack frequency and the headache intensity when associated with propranolol plus nortriptyline vs placebo plus propranolol plus nortriptyline, and (iv) no difference for any of the interest outcomes when associated with propranolol plus nortriptyline vs sodium valproate plus propranolol plus nortriptyline. The use of melatonin for cluster headache when compared with placebo showed a reduction in the daily number of analgesic consumption and no difference in the number of daily attacks. Adverse events were poorly reported by all of the studies. CONCLUSION: This review found that so far there are few clinical trials, with poor methodological quality about melatonin for primary headaches. The available evidence is not sufficient to support the use of melatonin in clinical practice for this population. Further research is still necessary for assess its effects (benefits and harms) for primary headaches patients. Number of Protocol registration in PROSPERO database: CRD42017067105 (available at https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017067105) .

Key Findings

Four randomized controlled trials were included (351 participants). According to the GRADE approach the quality of evidence was very low. The use of melatonin for migraine showed that (i) reduced the number of days with pain and the analgesic consumption when compared with placebo, (ii) no benefits on headache intensity, number of headache days and analgesics consumption when compared with amitriptyline, (iii) reduced the number of analgesic consumption, the attack frequency and the headache int

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 351
Age Range See abstract
Condition See abstract

MeSH Terms

  • Acetaminophen
  • Analgesics
  • Aspirin
  • Central Nervous System Depressants
  • Humans
  • Melatonin
  • Migraine Disorders
  • Randomized Controlled Trials as Topic
  • Treatment Outcome

Evidence Classification

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

Provenance

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