Skip to main content

Advertisement

Table 3 Sleep-Related TEAEs

From: Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder

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)
  1. TEAEs = treatment-emergent adverse events; LDX= lisdexamfetamine dimesylate.