Table 3.
Treatment-emergent adverse events by OSA primary therapy adherence (safety population).a
| TEAE, n (%) | Adherent (n = 324) | Nonadherent (n = 93) |
|---|---|---|
| At least 1 TEAE | 249 (76.9) | 61 (65.6) |
| Serious TEAE | 17 (5.2) | 3 (3.2) |
| TEAEs leading to discontinuation | 29 (9.0) | 7 (7.5) |
| Death | 1 (0.3)b | 0 (0.0) |
| Common TEAEsc | ||
| Headache | 30 (9.3) | 9 (9.7) |
| Insomnia | 28 (8.6) | 7 (7.5) |
| Nasopharyngitis | 25 (7.7) | 8 (8.6) |
| Anxiety | 24 (7.4) | 1 (1.1) |
| Dry mouth | 23 (7.1) | 10 (10.8) |
| Nausea | 23 (7.1) | 8 (8.6) |
| Feeling jittery | 20 (6.2) | 5 (5.4) |
| Upper respiratory tract infection | 19 (5.9) | 2 (2.2) |
| Dizziness | 17 (5.2) | 2 (2.2) |
| Decreased appetite | 8 (2.5) | 6 (6.5) |
OSA = obstructive sleep apnea, TEAE = treatment-emergent adverse event. aAdverse events are coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 18.0. bFrom sepsis (deemed not related to study drug). c≥5% in combined solriamfetol groups.