Supplement evidence

075 / 575Sleep formulation

Extended-release melatonin

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The short answer

Designed to sustain exposure and may fit sleep-maintenance or older-adult insomnia contexts.

Evidence and scope: Conditional or population-specific
This status does not grade the ingredient for every goal, outcome, or person.
Important limitation: Benefit depends on the population, formulation, baseline status, and objective; results should not be generalized.
Before deciding: Key concern: Same melatonin interactions; next-day sedation may be more relevant.

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 onset1–2 mg 1–2 hours before bed in many prolonged-release trials

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

Swallow whole; do not crush extended-release tablets.

Do not combine casually

Same melatonin interactions; next-day sedation may be more relevant.

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

63unique 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.

2020

Does not support the tested claimPMID 31674060 · ACTRN12613000648729

Melatonin for REM sleep behavior disorder in Parkinson's disease

REM sleep behavior events did not differ (3.4 versus 3.6 per week). Mild headache, fatigue, or morning sleepiness occurred in four melatonin and five placebo participants.

Published: 2020Duration: 8 weeks with 4-week observation before and after treatmentn=30 participants

Study design and methods

Design: Randomized, double-blind, placebo-controlled parallel trial
Population: 30 adults with Parkinson's disease and REM sleep behavior disorder
Intervention: Prolonged-release melatonin 4 mg before bedtime versus placebo
Outcome: Weekly REM sleep behavior disorder incidents and adverse events

Open research record ↗

2018

Mixed or qualifiedPMID 29347988 · ACTRN12611000734965

Efficacy of melatonin for sleep disturbance following traumatic brain injury

Subjective sleep quality and actigraphic sleep efficiency improved, but sleep-onset latency and daytime sleepiness did not. No serious adverse events occurred; the small, injury-specific sample limits generalization to ordinary insomnia.

Published: 2018Duration: Two 4-week periods separated by a 48-hour washoutn=33 participants

Study design and methods

Design: Randomized, double-blind, placebo-controlled crossover trial
Population: 33 adults with sleep disturbance after mild to severe traumatic brain injury
Intervention: Prolonged-release melatonin 2 mg nightly 2 hours before bedtime versus placebo
Outcome: Subjective sleep quality, sleep-onset latency, actigraphy, fatigue, anxiety, and adverse events

Funding or conflict note: Supported by Australia's National Health and Medical Research Council; several authors reported unrelated industry relationships.

Open research record ↗

Unscreened discovery appendix—not evidence28 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

Official evidence overviewPubMed bounded human-evidence search Live PubMed discovery searchNational Library of Medicine

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.

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.