Table 3.
TEAEs across the entire study.16
| TEAEs | Number (%) of Participants in Combined Solriamfetol Groups | ||
|---|---|---|---|
| Overall (N = 643) | Narcolepsy (n = 226) | OSA (n = 417) | |
| At least 1 TEAE | 482 (75.0) | 169 (74.8) | 313 (75.1) |
| Serious TEAE | 27 (4.2) | 6 (2.7) | 21 (5.0) |
| TEAEs leading to discontinuation | 59 (9.2) | 23 (10.2) | 36 (8.6) |
| Death | 1 (0.2)a | 0 | 1 (0.2) |
| Most common TEAEsb | |||
| Headache | 71 (11.0) | 31 (13.7) | 40 (9.6) |
| Nausea | 57 (8.9) | 26 (11.5) | 31 (7.4) |
| Nasopharyngitis | 54 (8.4) | 19 (8.4) | 35 (8.4) |
| Insomnia | 51 (7.9) | 16 (7.1) | 35 (8.4) |
| Dry mouth | 47 (7.3) | 14 (6.2) | 33 (7.9) |
| Anxiety | 46 (7.2) | 21 (9.3) | 25 (6.0) |
| Decreased appetite | 32 (5.0) | 18 (8.0) | 14 (3.4) |
| Upper respiratory tract infection | 32 (5.0) | 10 (4.4) | 22 (5.3) |
aDue to sepsis. b≥5% in combined solriamfetol groups for any indication. OSA = obstructive sleep apnea, TEAE = treatment-emergent adverse event.