Why Gabapentin is a Controlled Substance in Some States
Gabapentin has been reclassified as a controlled substance (typically Schedule V) in multiple U.S. states due to documented abuse potential, particularly when combined with opioids, despite remaining unscheduled at the federal level. 1, 2, 3
Federal vs. State Classification
Federal Status
- Gabapentin is not a federally scheduled controlled substance according to the FDA drug label 1
- The FDA acknowledges postmarketing reports of gabapentin misuse and abuse, particularly in individuals taking higher-than-recommended doses for unapproved uses 1
- Most cases of abuse occur in patients with a history of polysubstance abuse or those using gabapentin to relieve withdrawal symptoms from other substances 1, 4
State-Level Actions
- As of 2018, 14 of 51 U.S. states and jurisdictions have implemented legislative mandates requiring pharmacovigilance programs or reclassified gabapentin as a Schedule V controlled substance 2
- States significantly impacted by the opioid epidemic have taken independent action to monitor and regulate gabapentin prescribing 2, 3
- This fragmented geographic approach reflects the lack of federal oversight despite mounting evidence of abuse potential 2
Evidence Supporting Controlled Status
Abuse Patterns and Risk Factors
- Gabapentin abuse is well-documented, with the drug being highly sought after for potentiating opioid effects 2
- When combined with opioids, gabapentin significantly increases the risk of respiratory depression and opioid-related mortality 2, 5
- Misuse rates are approximately 1.1% in the general population but 22% in drug abuse treatment centers 4
- Individuals at highest risk include those with opioid abuse, mental illness, or previous prescription drug abuse history 3, 6
Mechanisms of Abuse
- Gabapentin is abused for multiple purposes: euphoria, potentiating opioid highs, reducing alcohol cravings, producing cocaine-like effects, and inducing sedation 3
- Patients typically take more than 3,000 mg/day (range 600-8,000 mg/day) when abusing the medication, far exceeding therapeutic doses 4
- All documented addiction cases occurred in patients with previous histories of alcohol, cocaine, or opioid abuse 4, 6
Withdrawal and Dependence
- Withdrawal symptoms occur within 12 hours to 7 days of discontinuation 4
- Symptoms include agitation, disorientation, and confusion, which resolve after restarting gabapentin 1
- Approximately 50% of patients prescribed gabapentinoids were treated continuously for at least 12 months, and sudden cessation can lead to physical and psychological withdrawal 7, 8
Clinical Implications
Prescribing Considerations
- Carefully evaluate patients for a history of drug abuse before prescribing gabapentin 1
- Monitor for signs of misuse including development of tolerance, self-dose escalation, and drug-seeking behavior 1, 3
- Long-term prescribing (>12 months) is common but often not recommended by clinical guidelines or of doubtful efficacy 7
Common Pitfall to Avoid
The most critical error is assuming gabapentin is completely safe because it lacks federal controlled substance status. The evidence clearly demonstrates significant abuse potential, particularly in vulnerable populations with substance use disorders 2, 5, 4. Providers must maintain the same vigilance with gabapentin as with other potentially addictive medications, especially when prescribing to patients with polysubstance abuse histories 6.
Geographic Variation
Prescribers must confirm with their respective state licensure authorities regarding local laws and regulations, as gabapentin's legal status varies significantly by jurisdiction 7, 3