Table 1.
Adverse events occurring in at least 5% of modafinil-treated subjects which occurred more frequently than in the control group during the three phase 3 studies (pooled data)
| Number (%) | of subjects | |
|---|---|---|
| Adverse event | Modafinil (n = 420) | Placebo (n = 213) |
| Insomnia | 115 (27) | 8 (4) |
| Headache | 82 (20) | 27 (13) |
| Anorexia/appetite decrease | 67 (16) | 6 (3) |
| Abdominal pain | 40 (10) | 17 (8) |
| Fever | 21 (5) | 7 (3) |
| Nervousness | 19 (5) | 9 (4) |
Reproduced from Cephalon, Inc. Modafinil (CEP-1538) tablets Supplemental NDA 20-717/S-019 ADHD Indication. Briefing document for Psychopharmacologic Drugs Advisory Committee Meeting March 23, 2006. Frazer, PA: Cephalon, Inc.