Table 3.
Duration of common early-onset TEAEs.
| OSA | Narcolepsy | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 119) |
Combined Solriamfetol (All Doses) (n = 355) |
Combined Solriamfetol (Doses ≤ 150 mg) (n = 237) |
Placebo (n = 59) |
Combined Solriamfetol (All Doses) (n = 177) |
Combined Solriamfetol (Doses ≤ 150 mg) (n = 118) |
|||||||
| TEAE | Events, n | Median Duration (Min, Max), Days |
Events, n | Median Duration (Min, Max), Days | Events, n | Median Duration (Min, Max), Days | Events, n | Median Duration (Min, Max), Days | Events, n | Median Duration (Min, Max), Days | Events, n | Median Duration (Min, Max), Days |
| Headache | 13 | 1 (1, 86) | 40 | 5.5 (1, 112) | 20 | 8 (1, 86) | 3 | 2 (1, 84) | 53 | 2 (1, 122) | 27 | 2 (1, 122) |
| Nausea | 7 | 3 (1, 83) | 33 | 10 (1, 86) | 17 | 8 (1, 86) | 1 | 4 (4, 4) | 25 | 5 (1, 77) | 11 | 5 (1, 77) |
| Decreased appetite | 1 | 68 (68, 68) | 28 | 57 (5, 91) | 13 | 18 (6, 83) | 1 | 16 (16, 16) | 20 | 79 (1, 120) | 11 | 80 (1, 96) |
| Anxiety | 0 | n/a | 25 | 26 (1, 94) | 9 | 36 (1, 94) | — | — | — | — | — | — |
| Insomnia | 2 | 6 (2, 10) | 16 | 8.5 (1, 49) | 4 | 21 (1, 49) | — | — | — | — | — | — |
| Feeling jittery | 0 | n/a | 15 | 4 (1, 49) | 7 | 4 (3, 49) | — | — | — | — | — | — |
| Dry mouth | — | — | — | — | — | — | 2 | 1.5 (1, 2) | 13 | 80 (1, 104) | 7 | 82 (8, 104) |
Safety population. Cells with “—” indicate that the TEAE was not a common early-onset TEAE in the given study population. n/a = not available, Max = maximum, Min = minimum, OSA = obstructive sleep apnea, TEAE = treatment-emergent adverse event.