Table 4 Sleep-Related TEAEs on LDX by Severity
Active doses (n = 358) n (%) | Mild | Moderate | Severe |
|---|---|---|---|
Initial insomnia | 11 (3.1) | 7 (2.0) | 0 (0) |
Insomnia | 37 (10.3) | 28 (7.8) | 8 (2.2) |
Middle insomnia | 7 (2.0) | 7 (2.0) | 0 (0) |
Somnolence | 1 (0.3) | 0 (0) | 0 (0) |
Sleep disorder | 1 (0.3) | 1 (0.3) | 0 (0) |
Abnormal dreams | 1 (0.3) | 0 (0) | 0 (0) |
Early morning awakening | 1 (0.3) | 0 (0) | 0 (0) |
Nightmare | 1 (0.3) | 0 (0) | 1 (0.3) |
Poor quality sleep | 0 (0) | 1 (0.3) | 0 (0) |
Hypersomnia | 0 (0) | 1 (0.3) | 0 (0) |
Fatigue | 9 (2.5) | 6 (1.7) | 2 (0.6) |