Table 3.
Adverse Events Reported by 5% or More of Patientsa
| Adverse Event | SWSD |
OSA |
Narcolepsy |
Total |
||||
|---|---|---|---|---|---|---|---|---|
| Modafinil | PL | Modafinil | PL | Modafinil | PL | Modafinil | PL | |
| n = 273 | n = 194 | n = 292 | n = 188 | n = 369 | n = 185 | n = 934 | n = 567 | |
| Headache | 63 (23) | 37 (19) | 73 (25)b | 22 (12) | 183 (50)b | 74 (40) | 319 (34)b | 133 (23) |
| Nausea | 31 (11)b | 7 (4) | 29 (10)b | 5 (3) | 47 (13)b | 7 (4) | 107 (11)b | 19 (3) |
| Infection | 12 (4) | 14 (7) | 34 (12) | 25 (13) | 51 (14) | 29 (16) | 97 (10) | 68 (12) |
| Nervousness | 18 (7)b | 3 (2) | 21 (7)b | 4 (2) | 30 (8) | 12 (6) | 69 (7)b | 19 (3) |
| Rhinitis | 9 (3) | 9 (5) | 18 (6) | 10 (5) | 42 (11) | 14 (8) | 69 (7) | 33 (6) |
| Back pain | 8 (3) | 3 (2) | 9 (3) | 7 (4) | 35 (9) | 16 (9) | 52 (6) | 26 (5) |
| Diarrhea | 12 (4) | 8 (4) | 16 (5) | 10 (5) | 30 (8) | 8 (4) | 58 (6) | 26 (5) |
| Anxiety | 8 (3) | 1 (<1) | 23 (8)b | 3 (2) | 13 (4)b | 1 (<1) | 44 (5)b | 5 (<1) |
| Dizziness | 8 (3) | 7 (4) | 18 (6) | 6 (3) | 17 (5) | 7 (4) | 43 (5) | 20 (4) |
| Dyspepsia | 10 (4) | 3 (2) | 8 (3) | 4 (2) | 26 (7) | 14 (8) | 44 (5) | 21 (4) |
| Insomnia | 18 (7)b | 2 (1) | 16 (5)b | 2 (1) | 11 (3) | 2 (1) | 45 (5)b | 6 (1) |
| Anorexia | 10 (4)b | 1 (<1) | 8 (3) | 3 (2) | 17 (5)b | 2 (1) | 35 (4)b | 6 (1) |
| Dry mouth | 9 (3) | 5 (3) | 9 (3) | 3 (2) | 19 (5)b | 1 (<1) | 37 (4)b | 9 (2) |
| Influenza syndrome | 14 (5) | 5 (3) | 10 (3) | 5 (3) | 13 (4) | 7 (4) | 37 (4) | 17 (3) |
| Pharyngitis | 11 (4) | 7 (4) | 5 (2) | 2 (1) | 23 (6) | 5 (3) | 39 (4) | 14 (2) |
| Accidental injury | 12 (4) | 9 (5) | 15 (5) | 9 (5) | 3 (<1)b | 12 (6) | 30 (3) | 30 (5) |
| Hypertension | 10 (4)b | 0 (0) | 14 (5) | 3 (2) | 6 (2) | 0 (0) | 30 (3)b | 3 (<1) |
OSA refers to obstructive sleep apnea; PL, placebo; SWSD, shift work sleep disorder.
a
Values are presented as number (SD).
b
p < .05 vs placebo.