Table 3.
Summary of depression, anxiety, and sleep disorder-related adverse events based on grouped preferred terms in subjects with ≥1 event
| Categorya Preferred term, n (%) | NB (n = 2545) | Placebo (n = 1515) | NB vs placebo P-value |
|---|---|---|---|
| Anxiety | 138 (5.4) | 50 (3.3) | 0.029 |
| Anxiety | 108 (4.2) | 43 (2.8) | 0.118 |
| Nervousness | 13 (0.5) | 2 (0.1) | 0.071 |
| Tension | 10 (0.4) | 2 (0.1) | 0.374 |
| Panic attack | 6 (0.2) | 3 (0.2) | 0.912 |
| Fear | 2 (<0.1) | 0 | 0.319 |
| Panic reaction | 1 (<0.1) | 0 | 0.476 |
| Generalized anxiety disorder | 0 | 1 (<0.1) | 0.087 |
| Hyperventilation | 0 | 0 | – |
| Depression | 47 (1.8) | 41 (2.7) | 0.014 |
| Depression | 24 (0.9) | 23 (1.5) | 0.088 |
| Depressed mood | 23 (0.9) | 18 (1.2) | 0.067 |
| Dysthymic disorder | 1 (0.1) | 1 (<0.1) | 0.613 |
| Suicidal ideation | 1 (<0.1) | 3 (0.2) | 0.045 |
| Major depression | 0 | 1 (<0.1) | 0.087 |
| Sleep disorders | 322 (12.7) | 119(7.9) | <0.001 |
| Insomnia | 233 (9.2) | 89 (5.9) | <0.001 |
| Sleep disorder | 34 (1.3) | 12 (0.8) | 0.311 |
| Abnormal dreams | 25 (1.0) | 6 (0.4) | 0.114 |
| Middle insomina | 16 (0.6) | 3 (0.2) | 0.095 |
| Poor quality sleep | 8 (0.3) | 2 (0.1) | 0.336 |
| Initial insomnia | 6 (0.2) | 4 (0.3) | 0.225 |
| Nightmare | 7 (0.3) | 1 (<0.1) | 0.615 |
| Sleep apnea syndrome | 5 (0.2) | 2 (0.1) | 0.594 |
| Terminal insomnia | 2 (<0.1) | 2 (0.1) | 0.604 |
32 mg naltrexone PR plus 360 mg bupropion PR (or 32 mg naltrexone immediate release plus 400 mg bupropion PR in study NB-201), PR prolonged release
Only categories that met statistical significance (P < 0.05) are reported here. Frequencies were analyzed using Cochran-Mantel-Haenszel general association test controlling for study. Additional potential anxiety symptoms (preferred terms: stress, restlessness, acute stress disorder, social avoidant behavior, hypervigilance, or social phobia) were reported in 19 (0.7%) and 16 (1.1%) NB and placebo subjects, respectively (P = 0.231).Additional potential depression symptoms (preferred terms: irritability, middle insomnia, libido decreased, stress, poor quality sleep, tearfulness, psychomotor hyperactivity, apathy, crying, depressive symptom, anhedonia, bereavement reaction, emotional distress, loss of libido, or negative thoughts) were reported in 125 (4.9%) and 55 (3.6%) NB and placebo subjects, respectively (P = 0.154). Additional symptoms of somnolence (preferred terms: somnolence, sedation, hypersomnia) were reported in 33 (1.3%) and 12 (0.8%) NB and placebo subjects, respectively (P = 0.087)