Cloxazolam treatment for patients with intractable epilepsy

We examined the antiepileptic effect of cloxazolam on seizures in 23 patients with intractable epilepsy. Most of the patients had central nervous system complications, as well as frequent seizures, and were being treated with polypharmacy. Cloxazolam was administered 1 to 5 mg/day (0.05 to 0.14 mg/kg) at initiation, in two divided doses daily, and gradually increased (1 to 4 mg/day; 0.05 to 0.15 mg/kg) every month at the outpatient clinic. Plasma levels of the main active metabolite, chloro-N-desmethyldiazepam, were measured in 13 patients. Four of 23 patients (17%) became seizure-free, and nine patients (39%) manifested a good response. Both patients with generalized and partial epilepsy manifested a good response. The spectrum of cloxazolam as an antiepileptic was wide. Effective doses were 0.07 to 0.56 mg/kg, and plasma effective levels of chloro-N-desmethyldiazepam were 12.3-115.1 ng/mL. Cloxazolam may be an effective and safe antiepileptic for intractable epilepsy, and should be used as an adjunct to other antiepileptic drugs or administered after other agents.