The U.S. Food and Drug Administration (FDA) has stepped up warnings about tianeptine, an unapproved antidepressant increasingly sold in gas stations and convenience stores under names like “Zaza,” “Tianna,” and “Neptune’s Fix.”
The substance, dubbed “gas station heroin” for its opioid-like effects, is illegal and not approved for medical use in the U.S., although it is legally marketed in some countries as an antidepressant.
Why It Matters
Tianeptine can be found in some gas stations and convenience stores, often with packaging that mimics legal supplements. Its misuse has drawn increasing attention, particularly due to the way it mimics the effects of opioids, and can cause serious and even fatal side effects.
According to the FDA, poison control center cases involving tianeptine exposure causing severe side effects have increased nationwide, from 11 in total between 2000 and 2013 to 151 in 2020 alone.
What To Know
Despite being illegal, the drug is sometimes illicitly added to foods and beverages or sold as a dietary supplement in the U.S. by some firms.
An FDA spokesperson told Newsweek: “The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive.”
The administration has also issued warning letters to companies distributing and selling unlawful tianeptine products, and issued import alerts to stop tianeptine shipments at the border.
What Is Tianeptine?
Tianeptine acts on the brain’s opioid receptors, which can produce feelings of euphoria at high doses, and the products feature claims—without evidence or FDA approval—that they can help users treat medical conditions, including addiction, pain and depression.
“Tianeptine has been used in tens of millions of patients over decades in Europe, Asia and South America and is well documented to be an antidepressant with efficacy roughly similar to first-line antidepressants,” Dr. Jonathan A. Javitch, a professor at Columbia University, told Newsweek.
Tianeptine is taken recreationally by some, and has been used to self-treat a variety of ailments, as well as being used chronically. However, abruptly stopping it use can induce withdrawal symptoms similar to those associated with opioids, such as craving, sweating, diarrhea, and others.
“Despite this, it has a remarkably safe track record in Europe and the abuse rate when used clinically is extremely low,” Javitch said.
He also said that used clinically, “there is no immediate perceptible effect on mood,” and patients do not experience euphoria.
Javitch specializes in experimental therapeutics in psychiatry and is a professor of molecular pharmacology and therapeutics at Columbia.
“Doses six times the clinical dose were shown not to produce euphoria, and thus tianeptine works over time through changing brain chemistry and circuitry and synaptic structure,” he said. However, he added that taking high doses in “an uncontrolled way is problematic.”
Javitch stressed that he did not believe products containing tianeptine should be sold in “an uncontrolled way with little oversight over dosing or combination with other medication.”
According to the FDA, reported adverse effects can include agitation, coma, confusion, death, drowsiness, hypertension, nausea, difficulty breathing, sweating, tachycardia (irregular heartbeat) and vomiting.
In 2024, there was a cluster of illnesses in New Jersey associated with the product “Neptune’s Fix,” which was found to contain tianeptine and synthetic cannabinoid receptor triggers. Adverse effects included tachycardia, seizure and even death.
FDA Crackdown
The FDA has been taking frequent steps in recent years to warn the public about the dangers of the drug, as well as trying to crack down on companies that include the ingredient in their products.
The agency recommends that health care professionals “encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder.”
Instead, the FDA said they should speak to their patients about evidence-based treatment options for opioid use disorder, or cases of depression, anxiety, or pain.
States are also taking action independently, and currently a dozen have banned or restricted the sale of tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee.
What People Are Saying
Dr. Jonathan A. Javitch, a professor at Columbia University, told Newsweek: “I don’t think it should be available at gas stations in an uncontrolled way with little oversight over dosing or combination with other medication. I fear that people will use much higher doses than are clinically indicated, and can escalate dosing and mix with other compounds.”
He added: “We just have to remember that tianeptine may have major potential as a treatment for depression and anxiety in the right patients, and we are trying to develop a precision psychiatry approach to predicting just which patients will respond to the mediation when used appropriately.”
Commissioner of Food and Drugs Dr. Martin Makary said in a note last month on the subject: “I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth.
“While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it.”
He added: “Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth.”
What Happens Next
The FDA said it will continue working with local and federal partners to crack down on illegal tianeptine products. It also urged consumers to report any adverse reactions involving tianeptine to the agency’s MedWatch program.
This article contains reporting by The Associated Press.
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