Randomized, double-blind,
placebo-controlled crossover trial of modafinil in the treatment of excessive
daytime sleepiness in narcolepsy.
Broughton RJ, Fleming JA, George CF, Hill
JD, Kryger MH,
Moldofsky H, Montplaisir JY, Morehouse RL, Moscovitch A
Division of Neurology,
Ottawa General Hospital, ON, Canada
Neurology 1997 Aug;49(2):444-51
ABSTRACT
Seventy-five patients meeting international diagnostic
criteria for narcolepsy enrolled in a 6-week, three-period, randomized,
crossover, placebo-controlled trial. Patients received placebo, modafinil
200 mg, or modafinil 400 mg in divided doses (morning and noon). Evaluations
occurred at baseline and at the end of each 2-week period. Compared with
placebo, modafinil 200 and 400 mg significantly increased the mean sleep
latency on the Maintenance of Wakefulness Test by 40% and 54%, with no
significant difference between the two doses. Modafinil, 200 and 400 mg,
also reduced the combined number of daytime sleep episodes and periods of
severe sleepiness noted in sleep logs. The likelihood of falling asleep as
measured by the Epworth Sleepiness Scale was equally reduced by both
modafinil dose levels. There were no effects on nocturnal sleep initiation,
maintenance, or architecture, nor were there any effects on sleep apnea or
periodic leg movements. Neither dose interfered with the patients' ability
to nap voluntarily during the day nor with their quantity or quality of
nocturnal sleep. Modafinil produced no changes in blood pressure or heart
rate in either normotensive or hypertensive patients. The only significant
adverse effects were seen at the 400-mg dose, which was associated with more
nausea and more nervousness than either placebo or the 200-mg dose. As
little as a 200-mg daily dose of modafinil is therefore an effective and
well-tolerated treatment of excessive daytime somnolence in narcoleptic
persons.
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