Table 2

Most common adverse events and reasons for discontinuation of treatment according

Patients (n (%))
Placebo run-in (n=72)Modafinil 200 mg/d (n=71)Modafinil 400 mg/d (n=70)Placebo washout (n=66)
*Adverse events occurring in 5% or more of patients in the 200 mg/day modafinil or 400 mg/day modafinil treatment phase.
Adverse event*:
    Headache11 (15)12 (17)7 (10)2 (3)
    Nausea4 (6)8 (11)4 (6)0
    Anxiety1 (1)6 (9)2 (3)0
    Dry mouth1 (1)5 (7)2 (3)0
    Nervousness2 (3)5 (7)4 (6)0
    Insomnia1 (1)4 (6)2 (3)1 (2)
    Diarrhoea1 (1)3 (4)4 (6)1 (2)
    Aesthenia (worsening fatigue)6 (8)2 (3)10 (14)4 (6)
Reasons for discontinuation:
    Adverse event1 (1)04 (6)1 (2)
    Lost to follow up01 (1)00