Tianeptine

Is tianeptine safe?

No. Tianeptine is a prescription antidepressant in France and parts of Europe, Asia and Latin America, but in the US it has never been approved and cannot lawfully be sold as a supplement. It acts on mu-opioid receptors, the same target as morphine and fentanyl, which is why it is sold in gas stations and vape shops as "gas station heroin". The FDA calls it "a dangerous and growing health trend".

It scores 19, below kratom at 29. The two share opioid-type dependence and a missing legal basis for sale. Tianeptine scores lower because US products carry doses dozens of times higher than the foreign medicine, have been spiked with other drugs, and are on the way to federal control.

What is the legal status of tianeptine?

The FDA's position, repeated in May 2025, is that tianeptine "is not approved by the FDA for any use", is not generally recognised as safe for use in food and does not meet the legal definition of a dietary ingredient. It calls tianeptine "an unsafe food additive". The agency has sent warning letters to sellers and placed products on import alert, so shipments can be held at the border. Sellers get around this by calling it a "research chemical" or a nootropic.

States moved first. According to the DEA, at least 15 had controlled or banned tianeptine by 2024: Michigan (2018), Oklahoma (2019), Alabama (2021), Arkansas, Ohio and Tennessee (2022), Florida, Kentucky, Minnesota and Mississippi (2023), and Georgia, Indiana, Louisiana, Maryland and Virginia (2024). Alabama's poison centre rate fell by 74.6% between 2021 and 2023 after its law took effect, while it kept rising in neighbouring states.

Federal control is pending. In July 2025 the Department of Health and Human Services recommended Schedule I, and on 8 July 2026 the DEA published a proposed rule to place tianeptine there, the category for drugs with high abuse potential and no accepted US medical use. Comments closed on 7 August 2026. As of October 2026 no final rule has been published. Abroad, the DEA notes that Bahrain (2003), Russia (2010), Turkey (2012) and Italy (2020) have banned or controlled it.

What do poison centres see?

The growth has been steep. US poison centres logged 11 tianeptine calls in the 14 years to 2013, then 81 in 2017, according to CDC. The FDA counts about 350 cases in 2024.

The largest study covers 892 cases where tianeptine was the only substance, reported from 2015 to 2023:

Outcome	Share of cases
Moderate effects	51.5%
Major (life-threatening) effects	12.0%
Admitted to hospital	40.1%
Admitted to critical care	22.9%
Withdrawal as the reason for the call	22.5%

People aged 50 and over were more likely to have major effects. The FDA lists agitation, drowsiness, confusion, a racing heart, high blood pressure, vomiting, slowed or stopped breathing, coma and death. A 2025 review of 52 published case reports found 7 deaths, all involving other substances.

Why the dose on the label means little

Abroad, tianeptine is taken at 12.5 mg three times a day. The FDA says US case reports describe people taking 50 mg to 10,000 mg a day, 1.3 to 250 times that amount, and the DEA cites one report of 63,720 mg in a day. Many users start for pain, low mood or to self-manage opioid withdrawal, then escalate as tolerance builds.

The products themselves vary. In January 2024 Neptune Resources recalled its Neptune's Fix elixirs and tablets in a Class I recall, the FDA's most serious category, because they contained an unapproved drug; the tablets held 150 mg each. Months earlier, New Jersey's poison centre had seen 17 patients after Neptune's Fix and similar products, against a usual two calls a year. Thirteen went to intensive care, seven needed a breathing tube, eight had seizures and one had a cardiac arrest. Lab tests found synthetic cannabinoids that were not on the label.

Who is most at risk

• People who take opioids, benzodiazepines such as alprazolam, gabapentinoids, sleeping pills or alcohol. Each adds to breathing suppression. Phenibut, alcohol, benzodiazepines and opioids were the most common co-exposures in CDC's data.
• People using tianeptine to come off opioids. It creates a dependence of its own, while approved treatments for opioid use disorder are proven to reduce deaths.
• Anyone taking antidepressants or anxiety medicines; the FDA notes serious harm in combination with them.
• Older adults, who had more major effects in poison centre data.

Routine drug screens may not detect tianeptine, so tell any doctor treating you that you use it.

What to do in an emergency

If someone is very drowsy, confused, breathing slowly or not at all, or has a seizure, call 911 at once. Naloxone may help because tianeptine acts on opioid receptors; give it if you have it and stay with the person. For advice on a suspected poisoning, call Poison Help at 1-800-222-1222 (US). If you use tianeptine daily and want to stop, talk to your doctor or call the SAMHSA helpline at 1-800-662-4357. Withdrawal can be severe, and stopping under medical care is safer.

How we scored it

Regulatory actions (5) is the weakest factor: no lawful route to sale, an import alert, state bans and a proposed Schedule I listing. Dose safety (15) and quality (15) reflect doses far above the foreign medicine, Class I recalls and spiked products. Interactions (25) and organ toxicity (30) reflect breathing suppression with other sedatives, seizures, heart rhythm problems and deaths in combination with other drugs.