Photo courtesy of the FDA Office of Regulatory Affairs, Health Fraud Branch.

The Food and Drug Administration (FDA) has issued a warning about the dangers of tianeptine, a tricyclic antidepressant sold in the United States as a dietary supplement under the brand names Neptune's Fix, Tianaa, and ZaZa, among others. The drug has earned the name “gas station heroin” for its addictive qualities and widespread over-the-counter availability, including in gas station convenience stores. In high doses, the drug induces euphoria similar to the effects of opioids. Withdrawal symptoms are also similar when the drug is stopped.

Tianeptine is the latest commercial product among a group of drugs, such as Kratom and others, that are marketed variously as mood enhancers, energy boosters, and a treatment for opioid withdrawal—all unproven claims. They also don't require a prescription and are commonly found at convenience stores, smoke shops, and internet sites. Their wide availability reinforces the misconception that they are a safe alternative to prescription medications for treatment of anxiety, depression, and opioid withdrawal.

In reality, the drugs are unregulated and addictive, with potentially serious adverse effects. Public health experts and clinicians are particularly alarmed about tianeptine because of mounting evidence of adverse effects, including agitation, confusion, tachycardia, apnea, seizures, and multiple incidents of coma and death. Tianeptine-related calls to poison control centers have surged in recent years. The New Jersey Poison Control Center reported 20 calls between June and November 2023 for severe clinical effects of tianeptine use, including seizures and cardiac arrest, compared to two or fewer calls in previous years.

Some countries have approved tianeptine in low doses for use as an antidepressant, but the drug is not approved for any medical use in the United States. The FDA classifies tianeptine as an “unsafe food additive” that also does not qualify as a dietary supplement, but companies continue to market it as a dietary supplement. Nine states have banned the sale of tianeptine products: Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio, and Tennessee, while legislation is pending in others.

The FDA advises consumers to avoid all products containing tianeptine, regardless of product claims. There are approved treatments for conditions these products falsely purport to address. People should talk to their health care providers about safe and effective alternatives if they need help.