Dangerously Overprescribed Gabapentin Should be Classified as a Controlled Substance

Evidence Shows Gabapentin Is Often Misused and Abused, Leading to Overdose Fatalities, Particularly When Used With Opioids

WASHINGTON, D.C. – The U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA) should promptly classify the markedly overprescribed seizure and neuropathic pain drug gabapentin and the closely related drug gabapentin enacarbil as schedule V controlled substances, because they are increasingly being misused, abused, and diverted, leading to dependence and overdose deaths, Public Citizen said today in a petition to the agencies.

“Gabapentin has been dangerously unscheduled as a controlled substance for too long despite increasing evidence of abuse and misuse and despite its strong similarity to pregabalin, which has been a schedule V drug for more than 15 years,” said Michael Abrams, senior health researcher with Public Citizen’s Health Research Group and lead author of the petition.

Gabapentin (available under the brand names Neurontin and Gralise and multiple generic versions) was first approved by the FDA in the U.S. in 1993 as an add-on therapy to treat certain types of seizures and more recently to treat neuropathic pain due to shingles infection (a condition known as postherpetic neuralgia). Gabapentin enacarbil, which is converted to gabapentin after ingestion, was approved by the FDA under the brand name Horizant in 2011 to treat moderate-to-severe restless leg syndrome and more recently to treat post-herpetic neuralgia.

Gabapentin is also widely prescribed for uses not approved by the FDA – so-called “off-label” uses – including treatment of alcohol use disorder, chronic cough, hiccups, post-surgical pain, and post-menopausal hot flashes. Recent data suggests that well over 80% of gabapentin prescriptions are for off-label uses.

Gabapentin, even at recommended doses, can cause neurological adverse events including dizziness, sleepiness, euphoria and other psychedelic effects, dependence, withdrawal symptoms upon discontinuation, and addiction. Additionally, there is human and animal evidence indicating that gabapentin can cause respiratory depression (slowed breathing), which can be fatal, especially when it is taken in combination with opioids or sedative drugs such as benzodiazepines.

Numerous recent studies have shown that gabapentin use increases the risk of opioid overdose death. Other research has shown that since 2002, there has been increasing diversion of gabapentin from legitimate medical purposes.

Despite these clear dangers, gabapentin is not federally scheduled and thus is completely unregulated by the DEA even though the closely-related drug pregabalin – which is marketed under the brand name Lyrica for treatment of certain seizure and neuropathic pain disorders – has been classified by the DEA as a schedule V controlled substance since 2005. Additionally, since 2019 gabapentin has been regulated as a controlled substance in the United Kingdom, and as of 2020, seven states in the U.S. have classified gabapentin as a schedule V controlled substance.

“Given gabapentin’s potential for serious harm and its obvious similarity to the already federally-scheduled pregabalin, it is illogical that gabapentin has not yet been classified by the DEA and FDA as a controlled substance,” said Abrams. “The failure of the DEA and FDA to schedule gabapentin is even more troubling given that the drug has been identified as a contributing factor to the opioid overdose epidemic that continues to plague our nation.”