Table 4.
Summary of Adverse Events After Single Doses of Lemborexant in Healthy Adult Subjects, Multiple Doses of Lemborexant in Healthy Adult and Elderly Subjects, and Multiple Doses of Lemborexant in Healthy Adult Japanese and White Subjects
| A: Study 001 | Lemborexant | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse Event, n (%) | Placebo(n = 16) | 1 mg(n = 6) | 2.5 mg(n = 6) | 5 mg(n = 6) | 10 mg(n = 6) | 25 mg(n = 6) | 50 mg(n = 6) | 100 mg(n = 6) | 200 mg(n = 6) |
| TEAEs | 7 (43.8) | 1 (16.7) | 0 | 1 (16.7) | 4 (66.7) | 2 (33.3) | 4 (66.7) | 2 (33.3) | 5 (83.3) |
| Treatment‐related TEAEs | 1 (6.3) | 0 | 0 | 0 | 2 (33.3) | 0 | 3 (50.0) | 2 (33.3) | 4 (66.7) |
| SAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B: Study 002 | Lemborexant | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse Event, n (%) | Placebo(n = 16) | 2.5 mg(n = 6) | 5 mg(n = 6) | 10 mg(n = 6) | 25 mg(n = 6) | Elderly 25 mg (n = 5) | 50 mg(n = 6) | 75 mg(n = 6) | |
| TEAEs | 11 (78.6) | 5 (83.3) | 5 (83.3) | 6 (100.0) | 5 (83.3) | 5 (100) | 6 (100) | 6 (100) | |
| Treatment‐related TEAEs | 6 (42.9) | 3 (50.0) | 3 (50.0) | 4 (66.7) | 4 (66.7) | 5 (100) | 6 (100) | 6 (100) | |
| SAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| TEAEs leading to discontinuation | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | |
| Japanese | White | |||||
|---|---|---|---|---|---|---|
| C: Study 003 | Lemborexant | Lemborexant | ||||
| Adverse Event, n (%) | Placebo(n = 6) | 2.5 mg(n = 6) | 10 mg(n = 6) | 25 mg(n = 6) | Placebo (n = 2) | 10 mg (n = 6) |
| TEAEs | 2 (33.3) | 1 (16.7) | 0 | 2 (33.3) | 1 (50.0) | 3 (50.0) |
| Treatment‐related TEAEs | 2 (33.3) | 1 (16.7) | 0 | 2 (33.3) | 0 | 3 (50.0) |
| SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 | 0 |
SAE indicates serious adverse event; TEAE, treatment‐emergent adverse event.