Modafinil

UK SPC (Modafinil 100mg tablets, eMC product 4319): '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, and a diagnosis of narcolepsy should be made according to the ICSD2 guideline; patient monitoring and clinical assessment of the need for treatment should be performed periodically. Long-term use: prescribers should periodically re-evaluate long-term use, as long-term efficacy beyond 9 weeks has not been evaluated. Elderly: patients over 65 years should commence therapy at 100 mg daily (limited data, potential for lower clearance and increased systemic exposure). Severe hepatic impairment: reduce the dose by half. Paediatrics: 'Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns' — use is not recommended below 18 years because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions. Modafinil should be discontinued at the first sign of rash and not re-started. US labelling for comparison: narcolepsy or obstructive sleep apnoea 200 mg once a day in the morning; shift work disorder 200 mg once a day about 1 hour before the start of the work shift; doses up to 400 mg/day as a single dose have been well tolerated but there is no consistent evidence of additional benefit over 200 mg/day. eMC section 4.5 was not fetched in this bundle; interaction entries marked 'US label' come from section 7 of the US prescribing information in the same bundle. Sections 4.4 and 4.8 were truncated at the source-fetch limit.