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Adverse event summary (safety analysis set)
| Category, n (%) | Placebo (n = 68) | LEM5 (n = 69) | LEM10 (n = 68) | FLZ (n = 68) |
|---|---|---|---|---|
| Subjects with ≥1 TEAE | 2 (2.9) | 5 (7.2) | 8 (11.8) | 5 (7.4) |
| Treatment-related TEAE | 1 (1.5) | 3 (4.3) | 5 (7.4) | 3 (4.4) |
| Severe TEAE | 0 | 0 | 0 | 0 |
| Serious TEAE | 0 | 0 | 0 | 0 |
| TEAEs in ≥2% of subjects in any active treatment group | ||||
| Somnolence | 0 | 1 (1.4) | 3 (4.4) | 2 (2.9) |
FLZ, flurazepam 30 mg; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; TEAE, treatment-emergent adverse event.
