Butalbital Controlled Substance Schedule
Butalbital is NOT a federally scheduled controlled substance in the United States, despite being a barbiturate with significant abuse potential, dependence risk, and clinical risks equivalent to scheduled barbiturates.
Regulatory Classification
- Butalbital remains unscheduled by the DEA, even though it carries the same clinical risks as scheduled barbiturates including habit formation, tolerance, dependence, and withdrawal seizures 1, 2
- This lack of scheduling occurs despite butalbital being a barbiturate with documented abuse liability, narrow margin of safety, and risk of dependence 3, 4
- For context, other barbiturates ARE scheduled: phenobarbital is Schedule IV, and secobarbital is also a controlled substance 4
Critical Clinical Implications of Non-Scheduled Status
The absence of scheduling does not mean butalbital is safe—it should be prescribed with the same caution as scheduled barbiturates:
- Butalbital produces psychological and physical dependence, with withdrawal syndrome occurring 2-4 days after discontinuation, including anxiety, restlessness, insomnia, tremor, seizures, and potentially death if untreated 5
- Intoxication from butalbital is clinically indistinguishable from alcohol intoxication 3
- Chronic use leads to tolerance, requiring higher doses, and creates medication-overuse headache when used more than twice weekly 1, 3
- Daily use indicates treatment failure and warrants immediate therapy adjustment 1, 2
Prescribing Recommendations
Limit butalbital-containing compounds to no more than twice weekly and use only as backup medication:
- Use butalbital only when NSAIDs, triptans, and other first-line agents are contraindicated or have failed 1
- Patients should be counseled to report signs of tolerance, escalating use, or daily headaches immediately 1
- For patients on long-term butalbital, wean slowly over 2 weeks prior to any planned procedure; if unable to wean, continue the medication to avoid perioperative withdrawal 6
- Monitor carefully for medication-overuse headache, which creates a vicious cycle of increasing headache frequency and medication use 1, 3
Safety Warnings
- Patients taking butalbital should avoid driving and operating heavy machinery entirely while on this medication 1
- Combination with other CNS depressants (alcohol, opiates, benzodiazepines) causes additive depressant effects and increases risk of profound sedation and respiratory depression 1
- Butalbital has depressogenic effects via GABA receptors, causing sedation, drowsiness, and altered mental status that can contribute to or mimic depressive symptoms 2