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Not FDA approved.
Reports of serious dermatologic adverse effects and psychiatric events has resulted in the FDA's Pediatric Advisory Committee unanimously recommending that a specific warning against the use of modafinil in children be added to the manufacturer's labeling; use only if first- and second-line treatments have failed and the benefits outweigh the risks.
Children less than 30 kg: 200-340 mg once daily
Children more than 30 kg: 300-425 mg
Randomized, double-blind, placebo-controlled pediatric studies have utilized an 85 mg film-coated tablet (currently not commercially available) to provide these dosages. All studies utilized a titration method but varied the length of titration (3 weeks vs 7-9 days); clinical improvement was noted earlier in the shorter titration period.