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Clobazam was synthesized in the 1960s with the primary goal of providing greater efficacy with fewer benzodiazepine-related side effects. FDA indications include adjunctive treatment of seizures associated with Lennox–Gastaut syndrome in patients two years or older. Non-FDA-approved indications include adjunctive therapy for seizures seen with Dravet syndrome, adjunctive therapy for refractory status epilepticus, adjunctive therapy of refractory focal epilepsy, catamenial epilepsy, and anxiety. This activity reviews indications, mechanism of action, administration, contraindications, monitoring, and toxicity associated with clobazam and the role of the interprofessional team in caring for patients with conditions that indicate therapy with clobazam. Objectives: Describe the mechanism of action of clobazam. Identify the approved and non-approved indications for clobazam. Review the potential side effects of clobazam. Explain the importance of detailed handoffs and interpersonal communication with other professionals involved in managing the patient receiving therapy with clobazam. Access free multiple choice questions on this topic.

Symptoms of clobazam overdose are almost similar to other typical benzodiazepines, which include CNS depression, drowsiness, dizziness, hypotension, respiratory depression, confusion and lethargy, ataxia, and rarely coma or death. These symptoms can become aggravated with concomitant use of other CNS depressing agents/medications like alcohol. In general, overdose monitoring includes airway protection, hemodynamic monitoring, IV fluid replenishment for hypotension. The usual antidote for benzodiazepine overdose is flumazenil; however, its use in clobazam toxicity has not been well established.

Clobazam is one of the newer generation antiepileptic medications introduced into the market with an FDA indication for add-on therapy for LGS. This approval came after the results from the Phase III randomized control trial in 2011. American Academy of Neurology (AAN) published practice parameters on the use of antiepileptic drugs (AED) for adult and pediatric epilepsy patients with LGS, which concluded that based on 2 class II study data suggests clobazam is probably effective for LGS.[6] It is worth noting that the efficacy of clobazam was dose-dependent in the trial, and the highest dose tried was 40 mg/day. Thus, one clinical pearl from the results was that since escalating the dose from 10 mg twice daily to 20 mg twice daily resulted in a dose-dependent reduction in seizure frequency, higher doses (up to 60mg/day) may be beneficial if tolerated. Clobazam has also proven its efficacy in treatment-resistant adult focal epilepsy (TRAFE), as 3 class III studies (small patient population and mixed epilepsy types) showed greater seizure frequency reduction compared to placebo, but with higher side effects as mentioned above.[6] AAN practice parameters on AED use for TRAFE concluded that it is probably effective as an add-on therapy for TRAFE. Using clobazam for its indications (both approved and otherwise) requires an interprofessional team approach because, as with any benzodiazepine, there is a risk associated with its use. This team includes the prescribing clinician or mid-level practitioner, the nursing staff, and the pharmacist. The pharmacist should verify dosing, perform a drug interaction check, and report any concerns to the prescriber. Nursing is in the best position to answer patient questions, counsel on dosing and adverse effects, and monitor these adverse effects, also informing the clinician f any issues present. The team should communicate regarding drug interactions, adverse effects, and therapeutic effectiveness to provide optimal patient care while minimizing adverse events. [Level 5]