Trial reportJournal of pineal research2012
Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults.
Trial report in Journal of pineal research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 49 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Melatonin Randomized Trial for Insomnia in the Elderly
A Pilot, Open-label Study to Evaluate the Effects of a Prostate Health Formulation on Scores Attained From the International Prostate Symptom Score (I-PSS) Questionnaire Among Overall Healthy Male Participants Who Report Lower Urinary Tract Complaints
Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.
Who cites it
49 citing papers in PubMed, 5 syntheses or guidelines pooled it, 109 citations in OpenAlex.
- The effect of melatonin supplementation on glycemic control in patients with type 2 diabetes.Frontiers in endocrinology · 2025Pooled it
- Pooled it
- Melatonin for Atypical Antipsychotic-Induced Metabolic Adverse Effects: A Meta-Analysis of Randomized Controlled Trials.BioMed research international · 2018Pooled it
- Clinical pharmacokinetics of melatonin: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Optimal dosages for melatonin supplementation therapy in older adults: a systematic review of current literature.Drugs & aging · 2014Pooled it
- Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers.Drugs in R&D · 2024Trial
- Exogenous melatonin's effect on salivary cortisol and amylase: A randomized controlled trial.Pharmacology research & perspectives · 2024Trial
- Trial
- Trial
- Bioavailability of OniriaDrugs in R&D · 2022Trial
- The Effect of Melatonin on Periodontitis.International journal of molecular sciences · 2021Trial
- The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.BMC women's health · 2020Trial
- The Effects of Melatonin on Elevated Liver Enzymes during Statin Treatment.BioMed research international · 2017Trial
- Pharmacokinetics of oral and intravenous melatonin in healthy volunteers.BMC pharmacology & toxicology · 2016Trial
- Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation?Critical care (London, England) · 2015Trial
- Melatonin beyond chronobiology: integrating pharmacokinetics, dose-exposure forecasting, and clinical evidence.Molecular biology reports · 2026Review
- Melatonin in Clinical Practice: Grey Zones Between Chronobiology, Insomnia and Consumer Supplementation.Clocks & sleep · 2026Article
- Optimizing Athlete Travel for Performance: A Scientific Blueprint for Athletes, Coaches, and Sports Medicine Staff.Sports medicine (Auckland, N.Z.) · 2026Review
- Pineal gland senescence: an emerging ageing-related pathology?Hormones (Athens, Greece) · 2026Review
- Serum melatonin predicts hepatic encephalopathy in patients with liver cirrhosis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
Abstract
Melatonin is increasingly used for the treatment of sleep disorders. Surge-sustained formulations consisting of combined immediate release and controlled release dosing may mimic the endogenous melatonin physiologic profile. However, relatively little is known about the pharmacokinetic properties of low-dose (<0.5mg) and high-dose (>2mg) melatonin in a combined immediate release/controlled release dose, especially in older adults who may also exhibit altered melatonin disposition. To assess this, we conducted a randomized, double-blind, placebo-controlled study of low-dose (0.4mg) and high-dose (4.0mg) melatonin (25% immediate release+75% controlled release) in 27 older adults with insomnia complaints and low endogenous melatonin levels to determine whether melatonin pharmacokinetic properties differ between these two doses. The time to maximum level (1.3hrs versus 1.5hrs), elimination half-life (1.8hrs versus 2.1hrs), and apparent total clearance (379L/hr versus 478L/hr) did not differ significantly between the low- and high-dose arms, respectively. The maximum concentration was 405 ±93pg/mL for the low-dose arm and 3999±700pg/mL for the high-dose arm, both of which are substantially higher than physiologic melatonin levels for this age group. In addition, subjects in the high-dose arm maintained melatonin levels >50pg/mL for an average of 10hrs, which could result in elevated melatonin levels beyond the typical sleep period. Renal and liver function parameters remained stable after 6wks of treatment. The linear pharmacokinetic behavior of melatonin observed in the elderly can form the basis for future studies exploring a wider range of dosing scenarios to establish exposure-response relationships for melatonin-mediated sleep outcomes.
Indexed as
Identifiers
What OpenQuestion holds
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.