Is gabapentin (anticonvulsant) a scheduled drug?

Gabapentin's Controlled Substance Status

Gabapentin is not a scheduled drug at the federal level, though some states have reclassified it as a Schedule V controlled substance due to increasing concerns about misuse and abuse potential. 1

Federal Classification Status

• Gabapentin is officially classified as a non-controlled substance by the FDA, as stated directly in the drug label 1
• Unlike pregabalin (which has a similar mechanism of action), gabapentin is not federally scheduled as a controlled substance 2
• The FDA label specifically states "Gabapentin is not a scheduled drug" 1

State-Level Regulations

• As of 2018,14 US states and jurisdictions have implemented or were in the process of implementing legislative mandates requiring pharmacovigilance programs for gabapentin 3
• Some individual states have taken action to reclassify gabapentin as a Schedule V controlled substance due to concerns about abuse 4
• This fragmented geographic approach to regulation creates inconsistency in monitoring and prescribing practices across the country 3

Abuse Potential and Risk Factors

• The FDA label acknowledges "a small number of postmarketing cases report gabapentin misuse and abuse," primarily in individuals taking higher than recommended doses for unapproved uses 1
• Individuals at highest risk for gabapentin abuse include those with:
  • History of opioid abuse
  • Mental illness
  • Previous prescription drug abuse 4
• Gabapentin may be abused for various effects including:
  • Euphoria
  • Potentiating opioid effects
  • Reducing alcohol cravings
  • Producing a cocaine-like high
  • Sedation or sleep 4

Clinical Implications and Monitoring

• When prescribing gabapentin, the FDA recommends carefully evaluating patients for history of drug abuse 1
• Clinicians should observe patients for signs of gabapentin misuse or abuse, including:
  • Development of tolerance
  • Self-dose escalation
  • Drug-seeking behavior 1
• Particular caution is warranted when prescribing to patients with polysubstance abuse history 2
• When combined with opioids, gabapentin significantly increases the risk of respiratory depression and opioid-related mortality 3

Dependence and Withdrawal Considerations

• There are rare postmarketing reports of withdrawal symptoms after discontinuing higher than recommended doses of gabapentin 1
• Withdrawal symptoms may include agitation, disorientation, and confusion 1
• Most individuals experiencing withdrawal had a history of polysubstance abuse or were using gabapentin to relieve withdrawal symptoms from other substances 1
• The FDA notes that the dependence and abuse potential of gabapentin has not been formally evaluated in human studies 1

Appropriate Prescribing Practices

• Gabapentin is FDA-approved for postherpetic neuralgia and epilepsy with partial-onset seizures, though most prescribing is off-label 4
• For neuropathic pain, effective doses typically range from 1800 to 3600 mg/day 5
• When prescribing, clinicians should document specific benefits, tolerance, and adverse effects, particularly when used long-term 6

While gabapentin remains federally unscheduled, the growing evidence of its abuse potential, particularly in patients with histories of substance abuse, warrants careful consideration when prescribing and monitoring its use.