Is 5-HTP FDA-approved?

Not in the US. Drugs@FDA lists no application with 5-HTP as an active ingredient, and it's sold as a dietary supplement, which FDA doesn't approve. Italy authorizes it as a medicine, but not for the US.

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

5-HTP

Also: 5-hydroxytryptophan, L-5-HTP, oxitriptan

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with 5-hydroxytryptophan (oxitriptan) as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

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

    Source: 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

    A randomised, double-blind study compared 5-HTP with fluoxetine in the 60 people with a first episode of depression who completed it: depression scores fell by similar amounts in both groups, and 73% on 5-HTP and 80% on fluoxetine responded.

    Source: PMID 23380314, checked 1 Nov 2026

  • In humans

    A double-blind, placebo-controlled study in 50 people with primary fibromyalgia: all the clinical measures studied improved significantly with 5-HTP. The authors called for further controlled studies.

    Source: PMID 2193835, checked 1 Nov 2026

How to track it in Peptimes

Add 5-HTP 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 “Approved outside the US”. In Italy, the medicines agency AIFA lists Tript-OH (oxitriptan) as an authorized prescription medicine. That authorization doesn’t apply in the US, and 5-HTP sold as a supplement doesn’t share it.

  • 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 5-HTP or any other compound.

More sources

  • Italian Medicines Agency (AIFA), medicines database, search “Tript-OH”, checked 1 Nov 2026: TRIPT-OH (oxitriptan, Alfasigma), capsules and granules taken by mouth, authorized in Italy, prescription only.
  • FDA, FDA 101: Dietary Supplements, checked 1 Nov 2026: FDA doesn’t approve dietary supplements for safety and effectiveness.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists 5-hydroxytryptophan or oxitriptan as an active ingredient.
  • FDA, Global Substance Registration System, Oxitriptan, checked 1 Nov 2026: its formula and the names 5-hydroxy-L-tryptophan, L-5-HTP and oxitriptan.

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