The Controversy Surrounding the Anti-Anxiety Medication Phenibut

Phenibut, often referred to as fenibut, phenigam, or 4-Amino-3-phenylbutanoic acid, is a popular nootropic known for its brain-enhancing properties. Available under labels such as Anvifen, Fenibut, and Noofen, this dietary supplement garners approximately 50,000 monthly searches, as reported by Science-Based Medicine. It has grown in popularity in the U.S. for its purported benefits in improving cognition, treating insomnia, alleviating anxiety, and even boosting sexual and athletic performance.

It sounds impressive, doesn’t it? But is it truly worth the risk?

Health professionals and public health experts urge caution. Before diving into the reasons, let’s explore some background on this supplement.

What Exactly is Phenibut?

Phenibut acts as a depressant on the central nervous system. Its structure closely resembles gamma aminobutyric acid (GABA), a neurotransmitter that soothes fear and anxiety by calming overactive neurons. By binding to a specific GABA receptor subtype, phenibut is thought to induce a comparable response, aiding in anxiety reduction, boosting feelings of euphoria, and enhancing mental clarity.

Phenibut, initially named phenigamma, was created in the 1960s by Soviet scientist Vsevolod Vasilievich Perekalin as an experimental therapy for children with psychiatric conditions. Its tranquilizing properties were discovered shortly after.

By 1975, phenigamma was rebranded as phenibut and became a staple in Russian medicine for treating various conditions such as insomnia, anxiety, depression, PTSD, alcoholism, alcohol withdrawal, sensory issues, and stuttering. Its effectiveness was so notable that it was included in cosmonauts’ medical kits to maintain calm and focus during space missions.

Despite being unapproved as a medication in many nations, online retailers have recently started marketing phenibut as a nootropic—a cognitive-enhancing supplement—and a remedy for social anxiety. It comes in tablet or powder form and is meant for oral consumption. However, its availability doesn’t necessarily make it safe to use.

Concerns About Phenibut

The surge in calls to poison control centers involving phenibut led Washington State University associate professor Janessa M. Graves, Ph.D., and her team to study this so-called designer drug.

"We consider it an emerging substance of concern," she states.

Their findings, published on September 4 in the CDC’s Morbidity and Mortality Weekly Report, revealed that poison control centers received 1,320 calls related to phenibut exposure between 2009 and 2019, with nearly half occurring in 2018 and 2019. Approximately 60% of these cases involved young adults aged 18 to 34.

The rise in poison control incidents in the U.S. suggests growing usage of the drug, likely fueled by the easy availability of dietary supplements online. Mild side effects linked to phenibut include drowsiness, restlessness, rapid heart rate, and confusion.

"More alarming is that some effects were life-threatening or fatal. Eighty individuals lapsed into comas, and three deaths were reported," Graves explains.

Another concern is the lack of published research on the long-term risks of phenibut or its interactions with other substances. Graves' study found that severe adverse effects often occurred when phenibut was combined with other drugs, such as opioids or alcohol.

"This is concerning," Graves notes. "Phenibut is readily available, and its popularity seems to be increasing."

Risks of Phenibut Addiction and Overdose

A major issue with phenibut is its potential to cause physical dependence, withdrawal, and addiction. Users may face withdrawal symptoms within hours or days of skipping a dose. These symptoms can include:

Self-medicating, particularly with dietary supplements that may inaccurately label or omit active ingredient dosages, increases the risk of overdose. Overdose symptoms of phenibut may include:

Is Phenibut Legal?

Since 2018, countries like Australia, Hungary, Lithuania, and Italy have classified phenibut as a controlled substance due to its potential for abuse and dependency. While it is approved as a medication in Russia and some neighboring nations, it remains unapproved in most of Europe. In the U.S., phenibut is unscheduled (no prescription required) but lacks FDA approval for any use. Despite this, it has appeared in certain dietary supplements.

The FDA oversees dietary supplements in the U.S. under different regulations than those for prescription or over-the-counter drugs. Consequently, the agency depends on manufacturers and distributors to assess the safety and labeling of their products before sale, ensuring they are free from adulterated or misbranded ingredients.

Phenibut does not qualify as a dietary ingredient under FDA guidelines, making any U.S. product containing it misbranded. The FDA has the authority to issue warnings and take enforcement actions against businesses selling such products and has sent warning letters to companies marketing phenibut-containing supplements.

Despite these measures, phenibut remains widely available in online dietary supplements, which is concerning, as highlighted in a 2019 review by University of Michigan Psychology professor Edward Jouney, D.O.

"Labeling it as a 'dietary supplement' is inaccurate and deceptive, given its pharmacological effects and potential to cause withdrawal and physical dependence," Jouney states.