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*: | ||||
| Headache | 11 (15) | 12 (17) | 7 (10) | 2 (3) |
| Nausea | 4 (6) | 8 (11) | 4 (6) | 0 |
| Anxiety | 1 (1) | 6 (9) | 2 (3) | 0 |
| Dry mouth | 1 (1) | 5 (7) | 2 (3) | 0 |
| Nervousness | 2 (3) | 5 (7) | 4 (6) | 0 |
| Insomnia | 1 (1) | 4 (6) | 2 (3) | 1 (2) |
| Diarrhoea | 1 (1) | 3 (4) | 4 (6) | 1 (2) |
| Aesthenia (worsening fatigue) | 6 (8) | 2 (3) | 10 (14) | 4 (6) |
| Reasons for discontinuation: | ||||
| Adverse event | 1 (1) | 0 | 4 (6) | 1 (2) |
| Lost to follow up | 0 | 1 (1) | 0 | 0 |