Zolpidem Drug Schedule Classification
Zolpidem is classified as a Schedule IV controlled substance by federal regulation. 1
Regulatory Classification
- The FDA explicitly designates zolpidem tartrate as a Schedule IV controlled substance under the Controlled Substances Act 1
- This classification reflects zolpidem's recognized potential for abuse and dependence, though lower than Schedule II or III substances 1
Clinical Implications of Schedule IV Status
- Schedule IV classification indicates that zolpidem has accepted medical use but carries risk for physical dependence and psychological addiction 1
- Studies in former drug abusers found that zolpidem 40mg produced effects similar to diazepam 20mg (also Schedule IV), while 10mg was difficult to distinguish from placebo 1
- Patients with a history of drug or alcohol addiction require careful monitoring when prescribed zolpidem due to increased risk for misuse, abuse, and addiction 1
Abuse and Dependence Potential
- Despite being marketed as having lower abuse potential than benzodiazepines, zolpidem can lead to tolerance and dependence, with approximately 50% of patients continuing use beyond 12 months 2
- Postmarketing surveillance has documented reports of abuse, dependence, and withdrawal symptoms following zolpidem use 1
- Withdrawal symptoms following abrupt discontinuation include fatigue, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attacks, nervousness, and abdominal discomfort, occurring in ≤1% of patients in clinical trials 1
- More severe withdrawal manifestations can include abdominal and muscle cramps, sweating, tremors, and convulsions consistent with sedative/hypnotic withdrawal syndrome 1