FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which was titrated to 50 mg or, if needed, 70 mg, or to placebo. In both studies, patients treated with the active drug had a significantly greater reduction from baseline in binge days/week than those treated with placebo. In the first study (n=374), the placebo-subtracted difference was 1.35 binge days/week. In the second study (n=350), the difference was 1.66 binge days/week.

The recommended dosage of lisdexamfetamine for treatment of binge eating disorder is 30 mg/day, which can be titrated in 20-mg increments per week to a maximum of 70 mg/day. The cost of 30 days' treatment is about $217.1

Patients with eating disorders have an increased risk of overuse of stimulants for weight loss. The long-term effectiveness and safety of lisdexamfetamine in this population remain to be determined.