Table 2.
Tolerability of pitolisant: AEs from all studies pooled
| AE | Pitolisant % (n), n=342 |
Modafinil % (n), n=98 |
Placebo % (n), n=158 |
|---|---|---|---|
| Headache | 16.1 (55) | 12.2 (12) | 12.7 (20) |
| Insomnia | 7.6 (26) | NR | 1.9 (3) |
| Nausea | 5.6 (19) | 2 (2) | 3.2 (5) |
| Weight increase | 2.9 (10) | NR | 1.3 (2) |
| Anxiety | 3.5 (12) | 3.1 (3) | NR |
| Depression | 2.3 (8) | 1 (1) | NR |
| Vomiting | 2.3 (8) | NR | NR |
| Irritability | 3.2 (11) | 3.1 (3) | 0.6 (1) |
| Diarrhea | 2 (7) | 6.1 (6) | 1.9 (3) |
| Dizziness | 2.3 (8) | 5.1 (5) | 2.5 (4) |
| Back pain | 2.3 (8) | NR | 0.6 (1) |
| Nasopharyngitis | 2 (7) | 6.1 (6) | 0.6 (1) |
Abbreviations: AE, adverse event; NR, not reported.