Melatonin for Insomnia
Verdict: Published with Warning
Across 4 PubMed studies, the evidence for Melatonin in Insomnia grades Tier B — preliminary evidence. Effective, but with safety or population caveats.
B 🟡 B Preliminary Evidence Published with Warning
Why this grade7-layer evidence engine
⚖️
Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.43
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
B · Published with Warning
Confidence
79%
Broadly consistent
Evidence level
E2
Multiple high-quality MAs (≥2 independent, consistent)
▸View the full decision path (audit trail)
- compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.428
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 高品質 SR/MA 顯示 positive (1 篇 > 0 negative)
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 1 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (4)L2 · primary research & systematic reviews
Efficacy of melatonin for chronic insomnia: Systematic reviews and meta-analyses
Finding: Adults with non-comorbid insomnia: melatonin NOT significantly effective on SOL, TST, or sleep efficiency; children/adolescents and comorbid insomnia: significant SOL/TST improvement
View on PubMed Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials
Finding: Melatonin reduced PSQI score WMD -1.24 (95% CI -1.77 to -0.71, p<0.001); largest effects in respiratory disease (-2.20) and metabolic disorder (-2.74) subgroups
View on PubMed Efficacy and tolerability of pharmacological treatments for insomnia in adults: A systematic review and network meta-analysis
Finding: Melatonin receptor agonists may be efficacious for sleep-onset insomnia with good safety, but orexin receptor antagonists outperformed melatonin/MRAs on overall efficacy and tolerability in adults
View on PubMed A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Evaluating the Evidence Base of Melatonin, Light Exposure, Exercise, and CAM for Patients with Insomnia Disorder
Finding: Network meta-analysis indicated melatonin effective in improving sleep-onset difficulties relative to placebo/other CAM comparators
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Cautious
no basis to conclude that melatonin is GRAS source↗
L4b EU EFSA
Supportive
melatonin and reduction of sleep onset latency source↗
L4c UK NHS
Cautious
Melatonin is available on prescription only. source↗
L4d TW TFDA / 衛福部
Against
褪黑激素產品屬藥品列管 source↗
L4e WHO
Not addressed
altered melatonin excretion source↗
L5a NIH Office of Dietary Supplements
Cautious
short-term use of melatonin supplements appears to be safe source↗
L5b Mayo Clinic
Cautious
Melatonin may help you sleep source↗
L5c Cleveland Clinic
Cautious
better than a placebo for sleep onset insomnia source↗
L5d Harvard Health
Against
minimal effect on sleeping throughout the night source↗
L5e Specialty Society (condition-mapped)
Against
clinicians should not use melatonin in adults to treat chronic insomnia source↗