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074 / 575Sleep formulation

Immediate-release melatonin

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The short answer

Best suited to sleep-onset timing and circadian objectives rather than maintaining sleep all night.

Evidence and scope
Supported for specific outcomes

This status does not grade the ingredient for every goal, outcome, or person.

Important limitation
Evidence supports a specific outcome, not a general wellness or longevity effect.
Before deciding
Key concern: Sedatives, alcohol, anticoagulants, seizure disorders, pregnancy, and driving require caution.

01 / PRACTICAL GUIDE

Dose, absorption, and combinations

These are indication-specific reference or studied ranges—not a personalized prescription. Start with the objective, then check the form, label, medicines, and health conditions.

Reference range by objective
Sleep onset0.5–3 mg 30–90 minutes before bed

Reference or studied range—not a personalized prescription. The product label or a clinician may specify a different dose.

Dose source
Jet lag0.5–5 mg near destination bedtime

Reference or studied range—not a personalized prescription. The product label or a clinician may specify a different dose.

Dose source

More is not automatically better. A clinician or product label may specify a different amount.

Absorption / solubilityFat-soluble / lipid-based

Fat-soluble or lipid-based. Absorption generally improves with a meal containing fat.

How it is commonly taken

Timing matters more than taking it with food; a heavy meal may delay absorption.

Do not combine casually

Sedatives, alcohol, anticoagulants, seizure disorders, pregnancy, and driving require caution.

Dose and use source

Dose and use links lead to primary or official source material. Search links are discovery tools, not proof that every returned paper applies.

02 / EVIDENCE

What the research says

We keep supportive, mixed, negative, safety, and contextual findings together. The headline never replaces the underlying papers.

2research papers in this ledger
2unique primary studies represented
164unique participants represented

These are audited counts for this JIVANA collection, not search-result totals. Participants are counted once when multiple papers use the same cohort; review papers are not added again to participant totals.

Open the research timelineResearch timeline

Entries are ordered by publication year. A study period appears only when the source reports it.

2024
Mixed or qualifiedPMID 37150895 · NCT04067791

Pharmacokinetics of extended-release compared with immediate-release melatonin

Immediate release peaked sooner (0.6 versus 1.56 hours) and higher, but had a shorter half-life (0.95 versus 1.63 hours). This small single-dose study establishes formulation exposure differences, not better sleep or other clinical outcomes.

Study design and methods
Design
Randomized, double-blind crossover pharmacokinetic study
Population
18 healthy adults aged 18–65
Intervention
Immediate-release or extended-release melatonin 4 mg after an 8-hour fast
Outcome
Time to peak, peak concentration, elimination half-life, exposure, and short-term safety
Open research record
2012
Mixed or qualifiedPMID 23129488 · ISRCTN05534585

Melatonin for sleep problems in children with neurodevelopmental disorders

Diary-recorded sleep increased by 22.4 minutes and sleep onset occurred 37.5–45.3 minutes earlier, but actigraphy did not show a clear total-sleep increase and waking shifted about 30 minutes earlier. Behavior and family function did not significantly improve; adverse events were mild and similar over three months.

Study design and methods
Design
Phase III randomized, double-masked, placebo-controlled multicenter trial
Population
146 children aged 3 years to 15 years 8 months with neurodevelopmental disorders and severe persistent sleep problems
Intervention
Immediate-release melatonin 0.5 mg, titrated through 2, 6, and 12 mg, 45 minutes before bedtime versus placebo
Outcome
Total sleep time, sleep-onset latency, waking time, behavior, family function, and adverse events

Funding or conflict note: Supported by the UK Department of Health; the authors declared no relevant organizational support or financial relationships.

Open research record
Unscreened discovery appendix—not evidence8 candidate publicationsSearch run: Aug 21, 2026

Complete for the displayed PubMed query at the search timestamp—not for all databases or every possible synonym. Candidates can be irrelevant, duplicate the same study, or report negative findings. They are never summed as evidence or participants until screened.

03 / SOURCES

Start with the source material

The live search is for discovery only. Search-result counts change and are not included in the audited totals above.

Recent PubMed discovery recordsDirect links to the first 12 records returned by the reproducible search. These are discovery candidates—not reviewed summaries or a count of supportive findings.
  1. Melatonin for Huntington's Disease (HD) gene carriers with HD-related sleep disturbance - A pilot study.Zadegan SA, Karagas N, Tanigaki W et al. · 2025 · Sleep medicine · PMID 40056659Open on PubMed
  2. A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults.Mun JG, Wang D, Doerflein Fulk DL et al. · 2024 · Journal of dietary supplements · PMID 37150895Open on PubMed
  3. Bioavailability of Oniria(®), a Melatonin Prolonged-Release Formulation, Versus Immediate-Release Melatonin in Healthy Volunteers.Román Martinez M, García Aguilar E, Martin Vílchez S et al. · 2022 · Drugs in R&D · PMID 35918587Open on PubMed
  4. A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation.Seiden DJ, Shah SM · 2019 · The primary care companion for CNS disorders · PMID 31381847Open on PubMed
  5. Therapeutic role of melatonin in migraine prophylaxis: A systematic review.Long R, Zhu Y, Zhou S · 2019 · Medicine · PMID 30653130Open on PubMed
  6. The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial.Bush SH, Lacaze-Masmonteil N, McNamara-Kilian MT et al. · 2016 · Trials · PMID 27515515Open on PubMed
  7. Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial.Gringras P, Gamble C, Jones AP et al. · 2012 · BMJ (Clinical research ed.) · PMID 23129488Open on PubMed
  8. The use of MElatonin in children with neurodevelopmental disorders and impaired sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS).Appleton RE, Jones AP, Gamble C et al. · 2012 · Health technology assessment (Winchester, England) · PMID 23098680Open on PubMed

04 / EXPERT CONTEXT

Expert context—not evidence

Expert positions are dated context—not scientific evidence. They never raise the evidence status or become consensus by repetition.

No direct, source-verified endorsement is currently recorded. Research authorship or discussion alone is not treated as endorsement.

Educational information only—not medical advice. Product quality, dose, medicines, pregnancy, and kidney or liver disease can materially change safety.