Dosing Regimen Effects of Modafinil for Improving
Daytime Wakefulness in Patients With Narcolepsy

Schwartz JR, Feldman NT, Bogan RK, Nelson MT, Hughes RJ.
*Integris Southwest and Baptist Medical Centers,
Oklahoma City, OK;
Palms of Pasadena Hospital, St. Petersburg, FL;
Sleep Disorders Center of South Carolina,
Baptist Medical Center, Columbia, SC; and
Cephalon, Inc., West Chester, PA
Clin Neuropharmacol. 2003 Sep-Oct;26(5):252-257


SUMMARY: In a multicenter, randomized, double-blind study the authors compared the efficacy of modafinil 400 mg once daily, 400 mg given in a split dose, or 200 mg once daily for maintaining wakefulness throughout the day in patients (N = 32) with narcolepsy reporting a positive daytime response to modafinil but late-afternoon/evening sleepiness. Efficacy evaluations included an extended Maintenance of Wakefulness Test (9:00 am to 9:00 pm), the Clinical Global Impression of Change scale, and the Epworth Sleepiness Scale. Modafinil demonstrated significant improvement in wakefulness as assessed by the Epworth Sleepiness Scale compared with placebo at baseline (all P < 0.001). Modafinil significantly improved patients' ability to sustain wakefulness, as demonstrated by mean sleep latency at week 3 compared with placebo at baseline (all P < 0.001). The 400-mg split-dose regimen improved wakefulness significantly in the evening compared with the 200-mg and 400-mg once-daily regimen (both P < 0.05). The percentage of patients rated as "much improved" or "very much improved" with respect to evening sleepiness was 27%, 82%, and 80% in the 200-mg, 400-mg once-daily, and 400-mg split-dose groups, respectively. Adverse events were mild to moderate in nature and included headache, nausea, nervousness, dyspepsia, pain, and vomiting (all 6%). Some patients may benefit from 400-mg doses of modafinil taken once daily compared with 200-mg doses. A split-dose 400-mg regimen may be superior to once-daily dosing for sustaining wakefulness throughout the entire waking day.

Modafinil: review
Modafinil: structure
Narcolepsy: causes
Modafinil and serotonin
Orexins to treat narcolepsy
Excessive daytime sleepiness
Modafinil as an antidepressant
Modafinil wakes up sleepy flies
Modafinil versus amphetamine
Modafinil versus methylphenidate
Narcolepsy and Sleep Disorders: some hotlinks

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