The use of clobazam as an adjunctive treatment for Lennox-Gastaut syndrome.

Clobazam, a 1,5-benzodiazepine, has been available in many European countries since the 1970s, both as an anxiolytic and as an antiepileptic. Recently, it has been marketed in the U.S. for the adjunctive treatment of Lennox-Gastaut syndrome, a seizure disorder accompanied by mental retardation and/or learning difficulties. The condition is usually refractory to many antiepileptic agents. The pivotal phase II and III trials of adjunctive clobazam are reviewed together with its postulated mode of action, pharmacokinetics and drug interaction profile. The data are discussed in terms of existing FDA-approved agents for Lennox-Gastaut syndrome and suggestions for further work.