Table 2.
Safety summary (safety analysis set).
| Category, n (%) | PBO (n = 57) | ZOL (n = 58) | LEM5 (n = 59) | LEM10 (n = 58) |
|---|---|---|---|---|
| Any TEAE | 4 (7.0) | 4 (6.9) | 5 (8.5) | 5 (8.6) |
| Treatment-related TEAE | 1 (1.8) | 1 (1.7) | 2 (3.4) | 1 (1.7) |
| Severe TEAE | 0 | 0 | 1 (1.7) | 0 |
| SAE | 0 | 0 | 0 | 0 |
| AE leading to study drug discontinuation | 0 | 0 | 2 (3.4) | 0 |
AE = adverse event, LEM5 = lemborexant 5 mg, LEM10 = lemborexant 10 mg, PBO = placebo, SAE = serious adverse event, TEAE = treatment-emergent adverse event, ZOL = zolpidem tartrate extended release 6.25 mg.