A Comparison of Once-Daily and Divided Doses of Modafinil in Children With Attention-Deficit/Hyperactivity Disorder

Jul 18, 2006The Journal of clinical psychiatry

Comparing once-daily and split doses of modafinil in children with ADHD in a controlled study

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Abstract

In a study of 248 children with ADHD, modafinil 300 mg once daily resulted in significantly greater improvement in symptoms compared to placebo.

Modafinil 300 mg taken once daily improved ADHD symptoms across all rating scales and subscales (p < .05).
Divided doses of 300 mg showed some significant but inconsistent improvements in ADHD symptoms.
In children weighing 30 kg or more, a 400 mg dose of modafinil was significantly more effective than placebo on clinician- and parent-completed scales (p < .05).
Insomnia was more frequent in the modafinil group (14%) compared to the placebo group (2%) (p = .03).
All dosing regimens of modafinil were well tolerated by participants.

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OBJECTIVE: This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of several modafinil dosing regimens in children with attention-deficit/hyperactivity disorder (ADHD) to determine whether modafinil can be given once daily in pediatric ADHD.

METHOD: Children and adolescents (age range, 6-13 years) (N = 248) with DSM-IV-defined ADHD were enrolled in a 4-week, double-blind, placebo-controlled study, conducted February-May 2002. The group was assigned to receive oral (100-mg tablets) modafinil 300 mg once daily (300 mg in the morning followed by placebo at midday), modafinil 300 mg as a divided dose (100/200 mg or 200/100 mg), or matching placebo. In children weighing > or = 30 kg, a higher dose of 400 mg (200/200 mg) was evaluated. Efficacy measures included the teacher-rated School Version and clinician-rated Home Version of the ADHD Rating Scale-IV and the parent-completed Conners' ADHD/DSM-IV Scales.

RESULTS: 223 children completed the study. Those who received modafinil 300 mg once daily showed a significantly greater improvement (change from baseline) than those who received placebo in symptoms of ADHD across all rating scales and subscales (all p < .05). Divided 300-mg doses of modafinil provided some significant but inconsistent improvements in ADHD symptoms. In children weighing > or = 30 kg, modafinil 400 mg (200/200 mg) was significantly superior to placebo on clinician- and parent-completed scales (all p < .05). Insomnia was the only adverse event to occur with significantly greater frequency in a modafinil group (200/100) than in the placebo group (14% vs. 2%) (p = .03).

CONCLUSION: Modafinil significantly improved ADHD symptoms in children. Once-daily dosing (300 mg) provided the most consistent improvement in symptoms. All dosing regimens of modafinil were well tolerated.

A Comparison of Once-Daily and Divided Doses of Modafinil in Children With Attention-Deficit/Hyperactivity Disorder

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