> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Denies Petition on Gabapentin Scheduling
- URL: https://www.fdaweb.com/fda-denies-petition-on-gabapentin-scheduling/
- Published: 2023-01-18T12:00:00.000Z
- Updated: 2026-09-14T18:12:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153565

FDA has denied a 2/2022 citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration (DEA) to open proceedings to place gabapentin (Almatica Pharma’s Gralise and Pfizer’s Neurontin) and gabapentin enacarbil (Arbor’s Horizant) into Schedule V of the Controlled Substances Act. The [petition](https://downloads.regulations.gov/FDA-2022-P-0149-0001/attachment%5F1.pdf?ref=fdaweb.com) said scheduling the drugs is necessary because they have a “marked potential for abuse with serious consequences that include psychological effects, physical dependence, seizures, suicide, and overdose death.”

In a 1/18 [denial letter](https://downloads.regulations.gov/FDA-2022-P-0149-0014/attachment%5F1.pdf?ref=fdaweb.com), FDA notes that while HHS and FDA evaluate drugs for abuse potential and make recommendations for scheduling, DEA is responsible agency for rendering scheduling decisions under the Controlled Substances Act. However, the agency did note that some of the concerns raised in the petition have already been addressed. In 2019, FDA issued a drug safety communication warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors.1

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the letter continued. “Gabapentinoids are often taken in combination with central nervous system (CNS) depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone. As a result of these findings, we required that new warnings about the risk of respiratory depression be added to the prescribing information of the gabapentinoids.”