Is Zolpidem a Controlled Substance?
Yes, zolpidem is classified as a Schedule IV controlled substance by federal regulation due to its potential for abuse and dependence. 1
Regulatory Classification
- Zolpidem is federally designated as a C-IV (Schedule IV) controlled substance because it can be abused or lead to dependence 1
- The FDA requires that zolpidem be kept in a safe place to prevent misuse and abuse, and selling or giving away zolpidem is against the law 1
Abuse and Dependence Potential
Studies in former drug abusers demonstrated that single doses of zolpidem 40mg produced effects similar (but not identical) to diazepam 20mg, while zolpidem 10mg was difficult to distinguish from placebo. 1
- Persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem and should be monitored carefully 1
- Zolpidem has demonstrated a lower dependence liability compared to traditional benzodiazepines, though the risk is not zero 2, 3
Withdrawal Syndrome
Physical dependence can develop with zolpidem, manifesting as withdrawal symptoms upon abrupt discontinuation:
- Reported withdrawal symptoms include fatigue, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attacks, nervousness, and abdominal discomfort 1
- More severe withdrawal can include abdominal and muscle cramps, sweating, tremors, and convulsions 1
- Seizures have been reported following zolpidem withdrawal, most commonly in patients taking daily dosages of 450-600mg/day, but cases have occurred at doses as low as 160mg/day 4
- Postmarketing reports confirm abuse, dependence, and withdrawal have occurred 1
Special Considerations for High-Risk Populations
For patients with mood instability and trauma exposure (as in your expanded context), additional caution is warranted:
- In primarily depressed patients treated with sedative-hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported 1
- Suicide attempts and completion have been linked with zolpidem use (OR 2.08; 95% CI 1.83-2.63) regardless of the presence of comorbid psychiatric illness 4
- The lowest number of tablets feasible should be prescribed at any one time for patients with depression 1
- Abnormal thinking and behavioral changes have been reported, including decreased inhibition, bizarre behavior, agitation, depersonalization, and visual/auditory hallucinations 1
Clinical Implications
- Zolpidem should only be prescribed for short-term use (4-5 weeks maximum per FDA approval) 5
- The American Geriatrics Society recommends avoiding benzodiazepine-like GABA receptor hypnotics, including zolpidem, in older adults due to concerns of sedation, cognitive impairment, and unsafe mobility with injurious falls 6
- Healthcare providers must monitor patients for tolerance, abuse, and dependence throughout treatment 1