Table 2.
Common early-onset TEAEs during week 1.
| OSA | Narcolepsy | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 119) |
Solriamfetol | Placebo (n = 59) |
Solriamfetol | ||||||||||
| 37.5 mg (n = 58) |
75 mg (n = 62) |
150 mg (n = 117) |
300 mg (n = 118) |
Combined (All Doses) (n = 355) |
Combined (Doses ≤ 150 mg) (n = 237) |
75 mg (n = 59) |
150 mg (n = 59) |
300 mg (n = 59) |
Combined (All Doses) (n = 177) |
Combined (Doses ≤ 150 mg) (n = 118) |
|||
| Headache | 6 (5.0) | 3 (5.2) | 3 (4.8) | 6 (5.1) | 6 (5.1) | 18 (5.1) | 12 (5.1) | 1 (1.7) | 2 (3.4) | 8 (13.6) | 11 (18.6) | 21 (11.9) | 10 (8.5) |
| Nausea | 2 (1.7) | 2 (3.5) | 1 (1.6) | 3 (2.6) | 7 (5.9) | 13 (3.7) | 6 (2.5) | 0 | 1 (1.7) | 4 (6.8) | 5 (8.5) | 10 (5.7) | 5 (4.2) |
| Decreased appetite | 0 | 1 (1.7) | 2 (3.2) | 7 (6.0) | 10 (8.5) | 20 (5.6) | 10 (4.2) | 0 | 3 (5.1) | 4 (6.8) | 7 (11.9) | 14 (7.9) | 7 (5.9) |
| Anxiety | 0 | 1 (1.7) | 1 (1.6) | 3 (2.6) | 9 (7.6) | 14 (3.9) | 5 (2.1) | — | — | — | — | — | — |
| Insomnia | 0 | 1 (1.7) | 0 | 2 (1.7) | 8 (6.8) | 11 (3.1) | 3 (1.3) | — | — | — | — | — | — |
| Feeling jittery | 0 | 3 (5.2) | 3 (4.8) | 1 (0.9) | 6 (5.1) | 13 (3.7) | 7 (3.0) | — | — | — | — | — | — |
| Dry mouth | — | — | — | — | — | — | — | 2 (3.4) | 1 (1.7) | 4 (6.8) | 4 (6.8) | 9 (5.1) | 5 (4.2) |
Values are n (%). Cells with “—” indicate that the TEAE was not a common early-onset TEAE in the given study population. OSA = obstructive sleep apnea, TEAE = treatment-emergent adverse event.