Gabapentin Controlled Substance Status by Location
Gabapentin is NOT a federally controlled substance in the United States, but several individual states have reclassified it as a Schedule V controlled substance or require reporting through prescription drug monitoring programs. 1, 2
Federal Status
- The FDA explicitly states that "gabapentin is not a scheduled drug" at the federal level in the United States. 1
- This differs from pregabalin (a similar gabapentinoid), which is classified as Schedule V federally. 3, 4
State-Level Variations
- Multiple U.S. states have independently reclassified gabapentin as a Schedule V controlled substance due to emerging abuse concerns. 2, 5
- Some states mandate reporting of gabapentin prescriptions to prescription drug monitoring programs (PDMPs) even without controlled substance classification. 2
- Prescribers must verify current regulations with their specific state licensure authorities, as gabapentin's legal status varies significantly by jurisdiction. 6
International Context (England)
- In England, gabapentin is not classified as a controlled substance but is subject to enhanced monitoring due to dependence concerns. 7
- Approximately 456,000 patients in England received gabapentinoids continuously for at least 12 months, representing 53.3% of those prescribed the medication. 7
Clinical Rationale for State Reclassification
- Gabapentin is commonly abused to potentiate opioid effects, and when combined with opioids, significantly increases respiratory depression risk and opioid-related mortality. 6, 5
- The FDA acknowledges postmarketing reports of gabapentin misuse and abuse, particularly among individuals with polysubstance abuse history or those using it to relieve withdrawal symptoms from other substances. 1
- Individuals at highest risk for gabapentin abuse include those with opioid abuse, mental illness, or previous prescription drug abuse history. 2, 4
Prescribing Precautions
- Carefully evaluate patients for history of drug abuse before prescribing gabapentin and monitor for signs of misuse (tolerance development, self-dose escalation, drug-seeking behavior). 6, 1
- Rare postmarketing reports document withdrawal symptoms (agitation, disorientation, confusion) after abrupt discontinuation of higher-than-recommended doses. 1
- Approximately 50% of patients prescribed gabapentinoids continue treatment for at least 12 months, despite this often not being recommended by clinical guidelines. 7, 6
Common Pitfall
The most critical error is assuming gabapentin has uniform legal status across all jurisdictions. Always verify local regulations before prescribing, as enforcement and monitoring requirements differ substantially between states and countries. 6, 2