Table 2.
Risk Estimates for Reported Somnolence With Atypical Antipsychotics Relative to Placebo in the Treatment of Bipolar Depression, Major Depressive Disorder, and Generalized Anxiety Disorder
| Antipsychotic | Diagnosis | Duration (wk) |
Treatment Armsa | No. of Patients, Total |
No. of Patients With Reported Somnolence |
Absolute Risk Increase (%) | NNTH, Mean (95% CI) |
|
|---|---|---|---|---|---|---|---|---|
| Mean (95% CI) | Pearson P |
|||||||
| Bipolar depression | ||||||||
| Aripiprazole15 | Bipolar I depression | 8 | Aripiprazole 5–30 mg/d (17.6 mg/d in study 1, 15.5 mg/d in study 2) | 360 | 27 | 3.4 (0 to ∞ to 7.0) | .1010 | NS |
| Placebo | 367 | 15 | ||||||
| Olanzapine16 | Bipolar I depression | 8 | Olanzapine 5–20 mg/d (9.7 mg/d) | 370 | 104 | 15.6 (10 to 21.3) | <.0001 | 6 (5 to 10) |
| Olanzapine/fluoxetirie | 86 | 18 | 8.5 (0.3 to 19.7) | .0414 | 12 (5 to 326) | |||
| Placebo | 377 | 47 | ||||||
| Quetiapine-IR17–20 | Bipolar I or II depression | 8 | Quetiapine-IR 300 mg/d | 853 | 193 | 16.3 (12.8 to 19.7) | <.0001 | 6 (5 to 8) |
| Quetiapine-IR 600 mg/d | 859 | 184 | 15.1 (11.7 to 18.4) | <.0001 | 7 (5 to 9) | |||
| Placebo | 602 | 38 | ||||||
| Quetiapine-XR21 | Bipolar I or II depression | 8 | Quetiapine-XR 300 mg/d | 137 | 40 | 23.5 (14.8 to 32.0) | <.0001 | 4 (3 to 7) |
| Placebo | 140 | 8 | ||||||
| Major depressive disorder | ||||||||
| Aripiprazole23 | Refractory MDD | 6 | Aripiprazole 2–20 mg/d (11.0–11.8 mg/d) | 189 | 13 | 3.2 (−1.5 to ∞ to 8.l) | .1643 | NS |
| Placebo | 190 | 7 | ||||||
| Olanzapine24 | Refractory MDD | 8 | Olanzapine (8.7 mg/d) | 199 | 24 | 6.7 (1.2 to 12.5) | .0161 | 15 (8 to 82) |
| Olanzapine/fluoxetine (8.6/48.8 mg/d) | 200 | 35 | 12.2 (6.1 to 18.5) | <.0001 | 8 (5 to 17) | |||
| Fluoxetine 50 mg/d (49.5 mg/d) | 206 | 11 | ||||||
| Quetiapine-XR26,27 | Refractory MDD | 6 | Quetiapine-XR 150 mg/d | 311 | 61 | 16.4 (11.6 to 21.4) | <.0001 | 6 (5 to 9) |
| Quetiapine-XR 300 mg/d | 316 | 80 | 22.1 (16.9 to 27.4) | <.0001 | 5 (4 to 6) | |||
| Placebo | 309 | 10 | ||||||
| Quetiapine-XR28,29 | MDD | 6 | Quetiapine-XR 50 mg/d | 181 | 33 | 9.4 (3.3 to 16.1) | .0018 | 11 (6 to 30) |
| Quetiapine-XR 150 mg/d | 330 | 72 | 12.9 (7.5 to 18.4) | <.0001 | 8 (5 to 13) | |||
| Quetiapine-XR 300 mg/d | 331 | 93 | 19.2 (13.5 to 24.9) | <.0001 | 5 (4 to 7) | |||
| Placebo | 338 | 30 | ||||||
| Quetiapine-XR30 | MDD | 8 | Quetiapine-XR 150 or 300 mg/d | 152 | 31 | 15.2 (7.9 to 22.8) | <.0001 | 7 (4 to 13) |
| Placebo | 155 | 8 | ||||||
| Risperidone31 | Refractory MDD | 6 | Risperidone 1–2 mg/d | 137 | 5 | 2.1 (−2.3 ∞ to 6.9) | .2760 | NS |
| Placebo | 131 | 2 | ||||||
| Generalized anxiety disorder | ||||||||
| Quetiapine-XR32–34 | GAD | 8 | Quetiapine-XR 50 mg/d | 452 | 114 | 15.0 (10.4 to 19.7) | <.0001 | 7 (5 to 10) |
| Quetiapine-XR 150 mg/d | 672 | 211 | 21.2 (17.0 to 25.3) | <.0001 | 5 (4 to 6) | |||
| Quetiapine-XR 300 mg/d | 444 | 145 | 22.4 (17.5 to 27.4) | <.0001 | 5 (4 to 6) | |||
| Placebo | 665 | 68 | ||||||
| Quetiapine-XR35 | Refractory GAD | 8 | Quetiapine-XR 50–300 mg/d | 209 | 47 | 10.5 (3.2 to 17.7) | .0051 | 10 (6 to 32) |
| Placebo | 200 | 24 | ||||||
a
Mean doses at study end are shown in parentheses.
Abbreviations: GAD = generalized anxiety disorder, IR = immediate release. MDD = major depressive disorder, NNTH = number needed to treat to harm., NS = nonsignificant, XR = extended release.