Is Pregabalin a Controlled Substance?
Yes, pregabalin is a Schedule V controlled substance in the United States, which is the lowest classification for drugs with potential for abuse and dependence. 1
Regulatory Classification
- The FDA explicitly designates pregabalin as a Schedule V controlled substance under the Controlled Substances Act 1
- Schedule V represents the lowest potential for abuse among controlled substances, but regulatory oversight is still required 2, 3
- This classification was implemented despite pregabalin not being active at receptor sites typically associated with drugs of abuse 1
Evidence Supporting Controlled Status
Abuse Potential
- In recreational drug users, pregabalin 450 mg produced subjective ratings of "good drug effect," "high," and "liking" similar to diazepam 30 mg 1
- Clinical trials showed 4% of pregabalin-treated patients reported euphoria compared to 1% on placebo, with rates ranging from 1-12% in certain populations 1
- Among opiate-dependent patients undergoing replacement therapy, 12.1% tested positive for pregabalin without medical indication, compared to only 2.7% in control groups 4
Physical Dependence
- Abrupt discontinuation causes withdrawal symptoms including insomnia, nausea, headache, and diarrhea 1
- Post-marketing reports document additional withdrawal symptoms of anxiety and hyperhidrosis 1
- Physical dependence symptoms have been observed in clinical studies, though the severity appears less than benzodiazepines 5
Clinical Implications for Prescribers
- Carefully evaluate all patients for history of drug abuse before prescribing pregabalin 1
- Exercise heightened vigilance when prescribing to patients with past or current opiate dependency, as this population shows significantly elevated abuse rates 4
- Monitor for signs of misuse including tolerance development, dose escalation, and drug-seeking behavior 1
- Case reports document patients obtaining pregabalin from multiple sources, with one patient receiving 88,500 mg over 28 days 2
Comparison to Other Controlled Substances
- Pregabalin likely has lower abuse potential than benzodiazepines, as euphoric effects are weak and not sustained during long-term use 5
- The Schedule V classification reflects this lower risk compared to Schedule IV benzodiazepines 3
- However, the abuse potential is real and documented, particularly in substance-dependent populations 4, 6