Modafinil

SPC §4.2 (Modafinil 100mg tablets): 'The recommended starting daily dose is 200 mg... Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose.' Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of the indicated disorders. A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline, and patient monitoring plus clinical assessment of the need for treatment should be performed periodically. LONG-TERM USE: physicians prescribing modafinil for an extended time should periodically re-evaluate long-term use, as long-term efficacy has not been evaluated beyond 9 weeks. HEPATIC IMPAIRMENT: the dose should be reduced by half in patients with severe hepatic impairment. ELDERLY: limited data; in view of potential lower clearance and increased systemic exposure, patients over 65 years should commence therapy at 100 mg daily. PAEDIATRIC: 'Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns' (§4.2, §4.4) — no paediatric dose is given in this source. §4.4 notes the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients aged <17, and modafinil should be discontinued at the first sign of rash and not re-started. CROSS-CHECK: the US label (Preferred Pharmaceuticals, 2026-07-14) gives 200 mg once daily in the morning for narcolepsy or OSA, and 200 mg once daily approximately 1 hour before the start of the work shift for shift work disorder, with doses up to 400 mg/day as a single dose well tolerated but no consistent evidence of additional benefit over 200 mg/day.