Gabapentin Scheduling Status
Gabapentin is NOT a federally scheduled controlled substance in the United States, though some individual states have reclassified it as Schedule V or mandated prescription monitoring program reporting. 1
Federal Classification
- The FDA explicitly states that "gabapentin is not a scheduled drug" at the federal level 1
- This differs from other commonly prescribed medications like opioids (Schedule II-III) and benzodiazepines, which have federal controlled substance designations 2
- Gabapentin does not exhibit affinity for benzodiazepine, opiate, or cannabinoid receptors, which traditionally define controlled substance classification 1
State-Level Variations
Prescribers must verify their specific state's regulations, as gabapentin's legal status varies significantly by jurisdiction. 3
- As of 2018,14 of 51 U.S. states and jurisdictions had implemented legislative mandates requiring pharmacovigilance programs or reclassified gabapentin 4
- Some states have reclassified gabapentin as a Schedule V controlled substance 5
- Other states require gabapentin prescriptions to be reported to Prescription Drug Monitoring Programs (PDMPs) without formal scheduling 6
- This fragmented state-by-state approach creates inconsistent regulatory oversight across the country 4
Clinical Implications of Non-Scheduled Status
Despite its federal non-controlled status, gabapentin carries documented abuse potential:
- Postmarketing reports document gabapentin misuse and abuse, particularly among individuals with poly-substance abuse history 1
- Gabapentin is commonly abused to potentiate opioid effects, and when combined with opioids, significantly increases respiratory depression risk and opioid-related mortality 4
- Individuals at highest risk include those with opioid abuse, mental illness, or previous prescription drug abuse history 5
- Approximately 50% of patients prescribed gabapentin receive continuous treatment for at least 12 months, and sudden cessation can cause physical and psychological withdrawal 3
Prescribing Recommendations
Carefully evaluate patients for a history of drug abuse before prescribing gabapentin and monitor for signs of misuse. 3, 1
- Document specific benefits, tolerance, and adverse effects, particularly with long-term use 7
- Watch for signs of gabapentin misuse including development of tolerance, self-dose escalation, and drug-seeking behavior 1
- Be aware that withdrawal symptoms (agitation, disorientation, confusion) can occur after discontinuing higher-than-recommended doses 1
- Recognize that gabapentin is the tenth-most prescribed medication in the U.S., with most prescribing occurring off-label 8