SynthesisEuropean journal of clinical pharmacology2015
Clinical pharmacokinetics of melatonin: a systematic review.
Synthesis in European journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 166 papers, 10 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
166 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Effectiveness and safety of melatoninergic agonists in preventing delirium in the ICU: an updated dose‒response meta-analysis of randomized controlled trials.Critical care (London, England) · 2026Pooled it
- Efficacy and safety of perioperative melatonin for postoperative delirium in patients undergoing surgery: a systematic review and meta-analysis.The Journal of international medical research · 2024Pooled it
- Effects of melatonin on postoperative sleep quality: a systematic review, meta-analysis, and trial sequential analysis.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2023Pooled it
- Controlled-release oral melatonin supplementation for hypertension and nocturnal hypertension: A systematic review and meta-analysis.Journal of clinical hypertension (Greenwich, Conn.) · 2022Pooled it
- Melatonin for pre-medication in children: a systematic review.BMC pediatrics · 2022Pooled it
- Melatonin and Its Analogs for Prevention of Post-cardiac Surgery Delirium: A Systematic Review and Meta-Analysis.Frontiers in cardiovascular medicine · 2022Pooled it
- Pharmaceuticals targeting signaling pathways of endometriosis as potential new medical treatment: A review.Medicinal research reviews · 2021Pooled it
- Efficacy of melatonin in animal models of intracerebral hemorrhage: a systematic review and meta-analysis.Aging · 2021Pooled it
- Melatonin for preoperative and postoperative anxiety in adults.The Cochrane database of systematic reviews · 2020Pooled it
- Influence of Acute Melatonin Administration on Human Physical Performance: A Systematic Review.Sports healthPooled it
- Trial
- Trial
- Melatonin for prevention of delirium in patients receiving mechanical ventilation in the intensive care unit: a multiarm multistage adaptive randomized controlled clinical trial (DEMEL).Intensive care medicine · 2025Trial
- Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers.Drugs in R&D · 2024Trial
- Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.Drugs in R&D · 2023Trial
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- Trial
- Dose assessment of melatonin in sepsis (DAMSEL2) study: Pharmacokinetics of two doses of oral melatonin in patients with sepsis.Journal of pineal research · 2022Trial
- Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial.European journal of clinical pharmacology · 2022Trial
- The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.BMC women's health · 2020Trial
106 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of the review was to provide an overview of studies investigating the pharmacokinetics of exogenous melatonin in humans and if possible, to provide recommendations for clinical use.
methodsThe review was conducted in accordance to PRISMA guidelines. A systematic literature search was performed in PubMed and Embase databases. The pharmacokinetic variables included maximal plasma/serum concentration (Cmax), time to maximal plasma/serum concentration (Tmax), elimination half-life (T1/2), area-under-the-curve plasma/serum concentrations (AUC), clearance (Cl), volume of distribution (VD), and bioavailability.
resultsThe literature search identified 392 records. Twenty-two studies were included in the review. Melatonin dosages varied between 0.3 and 100 mg and were administered either orally or intravenously. Cmax ranged from 72.1 (10 ml/h; 0.02 mg, IV) to 101,163 pg/ml (100 mg, oral). Tmax ranged between 15 (2 mg) and 210 min (10 mg). T1/2 ranged from 28 (0.005 mg, IV) to 126 min (4 mg, oral), whereas AUC ranged between 5400 (0.005 mg, IV) and 6.56 × 10(10) pg/ml × min (1 mg, oral). Cl ranged from 0.97 (0.005 mg, IV) to 132.50 L/min (6 mg, oral), whereas VD ranged between 35 (0.005 mg, IV) and 1602 L (4 mg, oral). Bioavailability of oral melatonin ranged from 9 to 33%. Pharmacokinetics was affected by age, caffeine, smoking, oral contraceptives, feeding status, and fluvoxamine. Critically ill patients displayed accelerated absorption and compromised elimination.
conclusionsDespite methodological differences between the included studies, Tmax was approximately 50 min following oral immediate-release formulations of melatonin. T1/2 was 45 min in both administration routes. Cmax, AUC, Cl, and VD varied extensively between studies. Bioavailability of oral melatonin was approximately 15%.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.