Is Temazepam a Controlled Substance?
Yes, temazepam is a Schedule IV controlled substance under federal law due to its potential for abuse, misuse, addiction, and physical dependence. 1
Regulatory Classification
- Temazepam is classified as a federal controlled substance (C-IV) because it can be abused or lead to dependence, and selling or giving away temazepam is against the law. 1
- The Schedule IV designation reflects documented concerns for abuse and dependence potential, requiring prescribers to follow DEA regulations for controlled substance prescribing. 2, 1
Clinical Implications of Controlled Status
- Abuse and misuse of temazepam can lead to serious adverse outcomes including delirium, paranoia, suicidal thoughts or actions, seizures, difficulty breathing, coma, and death—particularly when combined with other CNS depressants such as opioids or alcohol. 1
- Physical dependence develops with continued therapy, and abrupt discontinuation can precipitate acute withdrawal reactions including seizures, which can be life-threatening. 1
- Patients develop risk for addiction even when taking temazepam exactly as prescribed by their healthcare provider. 1
Prescribing Restrictions and Monitoring
- Temazepam should be kept in a safe place to prevent misuse and abuse, and prescribers must assess patients for history of alcohol abuse, prescription medicine abuse, or street drug dependence before prescribing. 1
- The controlled substance status necessitates that prescribers use state prescription drug monitoring programs (PDMPs) and follow DEA requirements for Schedule IV prescriptions. 1
- Temazepam is recommended for short-term use only (7-10 days, maximum 2 weeks) due to dependence risks and lack of long-term safety data. 3, 1
Special Populations at Higher Risk
- Patients with substance abuse history should preferentially receive ramelteon or suvorexant instead of any benzodiazepine including temazepam, as these alternatives are not DEA-scheduled drugs and carry lower abuse potential. 2, 3
- Carisoprodol, another centrally acting muscle relaxant, is similarly classified as a controlled substance and has escalated abuse patterns in the past decade, illustrating the broader concern about CNS depressant medications. 2
Common Pitfalls to Avoid
- Do not dismiss the controlled substance status as merely administrative—the Schedule IV classification reflects real clinical risks of tolerance, dependence, withdrawal seizures, and polysubstance abuse that require active monitoring. 1
- Do not prescribe temazepam without documenting specific benefits, tolerance, adverse effects, and patient counseling about controlled substance risks, particularly if considering use beyond the labeled 2-week duration. 2, 3
- Prescribers must recognize that temazepam misuse has been documented in injecting drug user populations, with gel-filled formulations still being misused despite attempts to create abuse-deterrent preparations. 4