Butalbital-Acetaminophen-Caffeine is a Schedule III Controlled Substance
Yes, butalbital-acetaminophen-caffeine 50 mg-325 mg-40 mg tablet is a controlled substance due to the butalbital component, which is a barbiturate with potential for abuse and dependence. 1
Classification and Composition
- Butalbital is a short to intermediate-acting barbiturate that acts on GABA receptors in the central nervous system 1
- The combination product contains 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine 1
- As a barbiturate-containing product, it falls under Schedule III controlled substance regulations 2
Clinical Uses and Concerns
- Indicated only for the relief of tension (muscle contraction) headache symptoms 1
- Evidence supporting efficacy for multiple recurrent headaches is unavailable 1
- The FDA label explicitly warns that butalbital is habit-forming and potentially abusable 1
- Barbiturate-containing analgesics like this combination have significant potential for:
Pharmacological Properties and Risks
- Butalbital is primarily metabolized in the liver through the cytochrome P450 system 2
- It can induce the CYP enzyme system, potentially affecting metabolism of other medications 2
- When combined with other CNS depressants (alcohol, opiates, benzodiazepines), it has additive depressant effects on the CNS and respiratory system 2
- Withdrawal symptoms typically appear 2-4 days after discontinuation and may include:
- Anxiety, restlessness, insomnia, tremor
- Seizures, delirium, hallucinations
- In severe cases: hyperthermia, circulatory failure, death 3
Perioperative Considerations
- For patients on long-term butalbital, abrupt discontinuation should be avoided 2
- If time allows before surgery, it should be weaned over 2 weeks 2
- If unable to wean prior to surgery, it should be continued perioperatively to avoid withdrawal 2
- Additive effects with anesthetics may cause hypotension, profound sedation, and potentially death 2
Evidence on Efficacy and Safety
- No evidence shows clinically important enhancement of analgesic efficacy due to the butalbital component 6
- Simpler analgesic formulations (acetaminophen, NSAIDs) or specific anti-migraine drugs are generally preferred 6
- Butalbital-containing products should be avoided in elderly patients and should not be used in children 6
- There are potential teratogenic concerns, with some studies suggesting associations between maternal butalbital use and certain congenital heart defects 7
Clinical Recommendations
- Due to its controlled substance status, prescriptions require appropriate DEA documentation and cannot be refilled as easily as non-controlled medications 2
- To minimize risk of dependence, limit use to no more than twice weekly 2
- Consider preventive migraine therapy if medication overuse is suspected or considered a risk 2
- For patients already taking butalbital-containing products, reevaluation of treatment is recommended 6