Cenobamate (CNB) is a new Anti Seizure Medicine (ASM) recently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of focal-onset seizures in adults. CNB is not approved for use in children and adolescents.
Makridis et al[3] reported their experience with CNB in 16 pediatric patients with Drug Resistant Epilepsy (DRE). CNB was initiated in pediatric patients at 12.5 mg once a day (0.22 mg/kg/d) and then titrated-up by 0.47 ± 0.27 mg/kg/d every 2 weeks.Treatment with CNB resulted in seizure-free or a significant seizure reduction of > 50% in more than two thirds of their patients. The rates of seizure freedom or strong reduction of seizure frequency were in line with data published for adults[reference needed]. No serious adverse events occurred in their cohort.
Most frequent adverse effects in their cohort were somnolence/fatigue which occurred during up-titration, in line with other reports[4]. Less frequently vertigo, nausea, balance disorder, diplopia, increased impulsive/agitated behavior, increased appetite with weight gain and impaired sleep quality were reported.