Neurology, cognition and sleep
Conceptual educational illustration of Melatonin in a glass specimen jar, labelled MOLECULE PROFILE.

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AGENT PROFILE

Melatonin

Nonpeptide agent

Nonpeptide indole hormone signaling through MT1/MT2 receptors and participating in circadian timing.

Sources checked · October 16, 2026

Published for review · Scientific, medical, translation and citation review pending. Reported uses are not authorized indications. Frequency reflects mentions in supplied sources, not sales or global clinical prevalence.

Identity and synonyms

Catalog label is recorded; analytical identity and equivalence are not established.

Nonpeptide agent · Nonpeptide small molecule

Detailed molecular class: Nonpeptide agent; see mechanism for subtype

Supplied sequence or chemical reference

PubChem CID: 896

Molecular formula: C13H16N2O2

IUPAC: N-[2-(5-methoxy-1H-indol-3-yl)ethyl]acetamide

Source: PC-MELATONIN

PubChem

Chemical structure reference

Database chemical reference; does not certify supplier vial, salt, isomer or formulation.

Mechanism

Nonpeptide indole hormone signaling through MT1/MT2 receptors and participating in circadian timing.

Evidence and critical reading

Reported scientific and empirical uses

Sleep and circadian rhythms

Sleep/circadian contexts; timing, formulation and population matter alongside amount.

Human evidence

In the EU, prolonged-release Circadin has a specific primary-insomnia indication in people aged 55 and over. This does not establish efficacy for all forms, ages or longevity uses.

Preclinical evidence

Do not equate mechanism, cell culture or animal work with a clinical outcome. The specific level is detailed in the evidence assessment.

Critical reading and limitations

In the EU, prolonged-release Circadin has a specific primary-insomnia indication in people aged 55 and over. This does not establish efficacy for all forms, ages or longevity uses.

In the EU, prolonged-release Circadin has a specific primary-insomnia indication in people aged 55 and over. This does not establish efficacy for all forms, ages or longevity uses.

Source-specific regimens

Descriptive source observations, not individual recommendations.

Regulatory product labeling

NOT A RECOMMENDATION.Each amount is attributed to the source identified for that entry: regulatory product labeling, human research, or community and practice sources. These source categories have different evidentiary roles. They are not medical advice, not a protocol, not a recommended or safe dose, and not evidence that it works. Do not use them to start, change or stop any treatment. Talk to a qualified healthcare professional.

Reported by EMA: Circadin, melatonin prolonged-release

2 mg · Amount per administration

Frequency
Once/day
Duration
Up to 13 weeks per labeling
Route
Oral, prolonged release
Context
Circadin, EU, primary insomnia age ≥55; not every melatonin formulation.
Presentation
2-mg prolonged-release tablet.
Interpretation
Product/indication specification; not a personal recommendation.

EMA-CIRCADIN · October 16, 2026

NOT A RECOMMENDATION.Each amount is attributed to the source identified for that entry: regulatory product labeling, human research, or community and practice sources. These source categories have different evidentiary roles. They are not medical advice, not a protocol, not a recommended or safe dose, and not evidence that it works. Do not use them to start, change or stop any treatment. Talk to a qualified healthcare professional.

Human-study exposure

Listed regimens preserve source/context. An empty layer means no regimen attributable to this identity was verified in this review; it does not prove universal absence of data.

Empirical handbook

Listed regimens preserve source/context. An empty layer means no regimen attributable to this identity was verified in this review; it does not prove universal absence of data.

Regulation and safety

Jurisdiction-specific regulatory context

EU: prolonged-release Circadin melatonin is authorized for short-term primary insomnia in patients ≥55 years. Other formulations/jurisdictions need separate review.

Adverse effects and unknowns

Somnolence and driving ability matter; fluvoxamine increases exposure and other sedatives can potentiate impairment per labeling.

Contraindications

Circadin: hypersensitivity to active substance/excipients; lack-of-data nonrecommendations are distinct from formal contraindications.

A complete list must match the exact authorized product. For experimental materials without verified human labeling, a complete contraindication set is not established here. No list does not mean safety.

Interactions

Fluvoxamine increases melatonin exposure; sedatives may increase functional impairment. Interactions concern the labeled product.

Separate documented interaction, pharmacologic plausibility and unknown interaction. Absence of a blend trial does not establish compatibility.

Studies and trials

Selected studies

No selected studies are attributed in this record.

Trials attributed in the package

No trials are attributed in this record.

Trial registration does not establish efficacy or validate commercial material.

Query candidates; attribution pending

Melatonin · 722 unfiltered query results, not authenticated trials

Query verification: October 16, 2026

Exact phrase intervention query; first three most recently updated records, not exhaustive. Aliases may be missed and heterogeneous products may appear. The total is the unfiltered registry query count, not authenticated trials. Source-integrity holds are excluded from ordinary listings.

View trial registry query

NCT00097474 · Effects of Hydrocortisone, Melatonin, and Placebo on Jet LagRegistry status: CompletedLast update posted: October 16, 2026Query verification: October 16, 2026

NCT00262470 · Treatment of Orthostatic IntoleranceRegistry status: Active, not recruitingLast update posted: October 16, 2026Query verification: October 16, 2026

NCT07869030 · Melatonin Effect on Immediate Dental Implants in the Posterior MandibleRegistry status: RecruitingLast update posted: October 15, 2026Query verification: October 16, 2026

Source issues and references

References include queries and bibliographic handbook attributions; not all are clinical studies. Human review remains pending.

  1. EMA-CIRCADIN

    EMA: Circadin, melatonin prolonged-release

    October 16, 2026

  2. PC-MELATONIN

    PubChem melatonin (CID 896)

    October 16, 2026

  3. SEARCH-PUBMED-melatonin

    PubMed/MED targeted search: TITLE_ABS:melatonin AND TITLE_ABS:randomized AND TITLE_ABS:insomnia

    October 16, 2026

  4. pdf01

    PEPNEXA 2.pdf

    October 16, 2026

  5. pdf02

    ELLA PEPTIDES.pdf

    October 16, 2026

  6. pdf03

    zlz list 26.8.5.pdf

    October 16, 2026

  7. pdf05

    PEPNEXA.pdf

    October 16, 2026

  8. pdf07

    US Peptide MangerCorp(1).pdf

    October 16, 2026

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