This unregulated Russian drug is harming Americans

An anti-anxiety drug developed in Russia in the 1960s is now sending more and more Americans to the hospital.

Phenibut (β-phenyl-γ-aminobutyric acid) is unregulated in the United States, but it’s legally available online as a nutritional supplement. It’s not some harmless herbal remedy, though. Phenibut is a psychotropic drug with the potency of a prescription-strength sedative—including all the related effects, such as intoxication, dependence, withdrawal, and addiction.

An increasing number of calls to poison control centers around the country indicate that phenibut exposures have risen sharply in recent years, according to Morbidity and Mortality Weekly Report (MMWR).

“The increase in phenibut exposures underscores the need for heightened awareness of phenibut as an emerging substance of use and misuse in the United States,” warned the MMWR authors.

What is phenibut?

Phenibut is an analog of GABA, an inhibitory neurotransmitter that’s involved in reducing excitability and anxiety while amplifying euphoria and cognitive function. Phenibut has been described as a GABA-mimetic and produces similar effects as GABA, though it can better penetrate the blood-brain barrier.

The drug was first synthesized in the early 1960s in St. Petersburg, Russia. Because of its cognitive-enhancing and tranquilizing effects, it was included in Russian cosmonauts’ medical kits for space travel.

Phenibut is reportedly still widely used in Russia—under the brand name Bifren—to treat a variety of conditions, including anxiety, insomnia, post-traumatic stress disorder, stuttering, and vestibular disorder.

In many countries, including the United States, phenibut is used recreationally for reducing anxiety and social inhibition, and for its mood-elevating and tranquilizing effects.

“Outside of Russia and the former Soviet Republics, phenibut was relatively unknown until 2011, when a quantity of the drug was seized in Sweden, and the European authorities were alerted,” wrote psychiatrist and addiction specialist Edward Jouney, DO, MS, in Current Psychiatry Reports. “Since that time, the availability of the drug through online procurement has increased, and reports regarding phenibut misuse, intoxication, and physical dependence have been published.”

In the United States, the European Union, and Australia, the drug can be easily purchased online as a nootropic (cognitive enhancing) dietary supplement. The FDA considers amino acids—like phenibut and GABA—to be dietary supplements, on par with vitamins. Because the FDA doesn’t review dietary supplements for safety and effectiveness, online vendors are able to sell phenibut in the United States legally and without regulation.

Safety concerns

Reports of phenibut-related adverse effects have risen sharply in the past few years (perhaps due to its ready online availability). US poison control centers reported fewer than 100 cases of phenibut exposure in 2015, but nearly 400 exposures in 2018, according to the MMWR report.

Between 2009 and 2019, poison control centers in all US states and the District of Columbia reported a total of 1,320 phenibut exposures, with many cases winding up in the hospital. Most (58.4%) occurred among adults aged 18–34 years, and the majority of reported exposures (75.5%) were in men. In 40% of adult cases, individuals had taken one or more other drugs concurrently with phenibut.

“The reason for the increase in phenibut-related exposures during 2009–2019 is not known; growing popularity and availability of the product through online retailers might be contributing factors,” according to MMWR.

Use and misuse of the drug can result in sedation, respiratory depression, and reduced levels of consciousness. Withdrawal symptoms include anxiety, agitation, and acute psychosis. Notably:

• The most common adverse health effects reported to poison centers included agitation (30.4%), drowsiness or lethargy (29.0%), tachycardia (21.9%), and confusion (21.3%).

• Coma was reported in 6.2% of cases.

• Major effects (ie, life-threatening or resulting in significant disability or disfigurement) occurred in 12.6% of reported exposures, including three deaths. Moderate effects (no long-term impairment) occurred in about half of cases (49.6%).

• Major effects, including one death, occurred in 10.2% of exposures when phenibut was the only drug or agent involved.

“Phenibut is a highly potent psychoactive substance, which has the potential to produce states of intoxication, physical dependence, withdrawal, and potentially addiction,” wrote Dr. Jouney.

Symptoms of phenibut intoxication and overdose are sedation, decreased consciousness, agitation, combativeness, delirium, and psychosis. Withdrawal symptoms include anger, irritability, tremulousness, heart palpitations, decreased appetite, and insomnia.

Unfortunately, a standard urine drug screen won’t detect the presence of phenibut, Dr. Jouney noted. Patients suspected of having a phenibut addiction should be referred to a substance use treatment facility for further evaluation, he added, though he acknowledged that there are no treatments specifically designed for phenibut addiction.

“Given the concerns published in multiple recent case reports, the regulatory authorities should vigorously review the legal status and classification of phenibut, since it does not function as [a] nutritional or dietary supplement as currently advertised,” Dr. Jouney wrote.