(1) Modafinil, a psychostimulant, has been
available in France for the treatment of narcolepsy and idiopathic
hypersomnia since 1994.
(2) The initial clinical file was inadequate to
judge its possible clinical value.
(3) In narcolepsy three new short-term clinical
trials have compared modafinil with a placebo (nearly 500 patients
treated with modafinil).
(4) These trials show that the effects of
modafinil on daytime drowsiness are only moderate (average reduction
of one unwanted sleep episode a day) but are subjectively better than
those of a placebo. In all, 84% of patients preferred the modafinil
period to the placebo period during a cross-over trial. In contrast,
modafinil does not improve cataplexy.
(5) No new trials have been done in idiopathic
(6) The effects of modafinil persist for at
least four months according to a double-blind placebo-controlled
(7) The safety profile of modafinil appears to
be similar to that of non amphetamine psychostimulants.
(8) There is currently no evidence of dependence
leading to withdrawal symptoms after abrupt treatment cessation, or of
a risk of abuse.