Table 3 Sleep-Related TEAEs
n (%) | Placebo (n = 62) | 30 mg/d LDX (n = 119) | 50 mg/d LDX (n = 117) | 70 mg/d LDX (n = 122) | Active Doses (n = 358) |
|---|---|---|---|---|---|
Initial insomnia | 2 (3.2) | 4 (3.4) | 7 (6.0) | 7 (5.7) | 18 (5.0) |
Insomnia | 3 (4.8) | 23 (19.3) | 20 (17.1) | 26 (21.3) | 69 (19.3) |
Middle insomnia | 0 (0) | 5 (4.2) | 2 (1.7) | 6 (4.9) | 13 (3.6) |
Somnolence | 2 (3.2) | 1 (0.8) | 0 (0) | 0 (0) | 1 (0.3) |
Sleep disorder | 2 (3.2) | 0 (0) | 2 (1.7) | 0 (0) | 2 (0.6) |
Abnormal dreams | 0 (0) | 0 (0) | 0 (0) | 1 (0.8) | 1 (0.3) |
Early morning awakening | 0 (0) | 0 (0) | 0 (0) | 1 (0.8) | 1 (0.3) |
Nightmare | 0 (0) | 0 (0) | 0 (0) | 2 (1.6) | 2 (0.6) |
Poor quality sleep | 0 (0) | 1 (0.8) | 0 (0) | 0 (0) | 1 (0.3) |
Hypersomnia | 0 (0) | 1 (0.8) | 0 (0) | 0 (0) | 1 (0.3) |
Fatigue | 3 (4.8) | 9 (7.6) | 5 (4.3) | 3 (2.5) | 17 (4.7) |