Efficacy and safety of gabapentin monotherapy were evaluated in 33 children with 
newly diagnosed absence epilepsy in two identical, double-blind, 
placebo-controlled trials in which a 2-week double-blind treatment phase was 
followed by a 6-week open-label phase. Primary efficacy criterion was seizure 
frequency change from baseline to end of double-blind treatment derived from 
quantified electroencephalograms. Primary efficacy analyses compared treatment 
differences in the 2-week double-blind phase. Gabapentin did not significantly 
decrease or increase seizure frequency compared with placebo. Low dosages with 
possibly subtherapeutic plasma levels may have contributed to the lack of 
demonstrable efficacy. Somnolence and dizziness were the only adverse events 
reported by at least two patients during gabapentin treatment. No clinically 
important changes in laboratory assessments or other safety parameters were 
observed. Gabapentin monotherapy at dosages ranging from 9.7 through 19.1 
mg/kg/day is well tolerated in pediatric patients aged 4 through 12 years with 
absence epilepsy.