Table 3.
Safety summary (safety analysis set)
| PBO (n = 319) | LEM5 (n = 314) | LEM10 (n = 314) | |
|---|---|---|---|
| Category, n (%) | |||
| Any TEAE | 200 (62.7) | 192 (61.1) | 187 (59.6) |
| Any treatment-related TEAE | 44 (13.8) | 78 (24.8) | 91 (29.0) |
| Any severe TEAE | 10 (3.1) | 13 (4.1) | 8 (2.5) |
| Any serious TEAE | 5 (1.6) | 7 (2.2) | 9 (2.9) |
| Any TEAE leading to discontinuation of study drug | 12 (3.8) | 13 (4.1) | 26 (8.3) |
| Any TEAE leading to interruption of study drug | 7 (2.2) | 13 (4.1) | 8 (2.5) |
| Death | 0 | 0 | 0 |
| Events reported in >2% of participants in any active treatment group and more than PBO by MedDRA preferred term, n (%) | |||
| Somnolence | 5 (1.6) | 27 (8.6) | 41 (13.1) |
| Headache | 21 (6.6) | 28 (8.9) | 21 (6.7) |
| Influenza | 15 (4.7) | 15 (4.8) | 16 (5.1) |
| Upper respiratory tract infection | 10 (3.1) | 13 (4.1) | 11 (3.5) |
| Fatigue | 1 (0.3) | 12 (3.8) | 11 (3.5) |
| Back pain | 8 (2.5) | 12 (3.8) | 9 (2.9) |
| Urinary tract infection | 7 (2.2) | 4 (1.3) | 9 (2.9) |
| Gastroenteritis | 4 (1.3) | 5 (1.6) | 7 (2.2) |
| Nightmare | 1 (0.3) | 4 (1.3) | 7 (2.2) |
| Nausea | 3 (0.9) | 8 (2.5) | 4 (1.3) |
| Abnormal dreams | 6 (1.9) | 7 (2.2) | 4 (1.3) |
| Arthralgia | 9 (2.8) | 14 (4.5) | 3 (1.0) |
A TEAE was defined as an adverse event with onset date on or after the first dose of study drug up to 14 days after the last dose of study drug. Participants with two or more TEAEs with the same preferred term are counted only once for that preferred term. LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; MedDRA, Medical Dictionary for Regulatory Activities (Version 21.0); PBO, placebo; TEAE, treatment-emergent adverse event.