Is melatonin FDA-approved?

No. In the US melatonin is sold as a dietary supplement, and FDA doesn't approve supplements. Drugs@FDA lists no melatonin drug.

Checked 1 Nov 2026. The sources are below, with the non-US regulator in More sources.

Melatonin

Also: N-acetyl-5-methoxytryptamine, Circadin, Slenyto

Status label in the Peptimes Library
Dietary Supplement
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Dietary supplements aren't FDA-approved: FDA does not approve them for safety and effectiveness.

    Source: FDA, checked 1 Nov 2026

  • FDA status

    Drugs@FDA lists no application with melatonin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    In a 3-week randomised, double-blind trial in 354 primary-care patients aged 55 to 80 with insomnia, more people improved in both sleep quality and morning alertness with prolonged-release melatonin (Circadin) than with placebo: 26% vs 15%.

    Source: PMID 17875243, checked 1 Nov 2026

  • Review of studies

    A 2013 review of 19 placebo-controlled trials (1,683 people with primary sleep disorders) found that melatonin shortened the time to fall asleep by about 7 minutes and lengthened total sleep by about 8 minutes. The authors called the effects modest.

    Source: PMID 23691095, checked 1 Nov 2026

How to track it in Peptimes

Add melatonin in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Dietary Supplement”.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell melatonin or any other compound.

More sources

  • FDA, FDA 101: Dietary Supplements, checked 1 Nov 2026: FDA doesn’t approve dietary supplements for safety and effectiveness.
  • European Medicines Agency, Circadin and Slenyto, checked 1 Nov 2026: melatonin medicines authorised for use in the European Union.
  • FDA, Global Substance Registration System, Melatonin, checked 1 Nov 2026: its formula and the name Circadin.

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