Table 4. Treatment-Emergent Adverse Events During Treatment and Follow-up Periods, Safety Analysis Seta.
| Event | No. (%) | |||
|---|---|---|---|---|
| Placebo (n = 209) | Zolpidem ER 6.25 mg (n = 263) | Lemborexant 5 mg (n = 266) | Lemborexant 10 mg (n = 268) | |
| TEAE | 53 (25.4) | 93 (35.4) | 74 (27.8) | 82 (30.6) |
| Treatment related | 16 (7.7) | 41 (15.6) | 30 (11.3) | 39 (14.6) |
| Severe | 3 (1.4) | 8 (3.0) | 1 (0.4) | 2 (0.7) |
| Serious | 0 | 4 (1.5) | 2 (0.8) | 0 |
| Leading to study discontinuation | 2 (1.0) | 7 (2.7) | 2 (0.8) | 3 (1.1) |
| Leading to interruption of study drug | 1 (0.5) | 2 (0.8) | 1 (0.4) | 0 |
| Death | 0 | 0 | 0 | 0 |
| TEAE reported in >2% of participants in any active treatment group | ||||
| Headache | 13 (6.2) | 14 (5.3) | 17 (6.4) | 13 (4.9) |
| Somnolence | 4 (1.9) | 4 (1.5) | 11 (4.1) | 19 (7.1) |
| Urinary tract infection | 2 (1.0) | 2 (0.8) | 3 (1.1) | 9 (3.4) |
| Nasopharyngitis | 3 (1.4) | 1 (0.4) | 7 (2.6) | 1 (0.4) |
| Upper respiratory tract infection | 4 (1.9) | 2 (0.8) | 6 (2.3) | 1 (0.4) |
| Dizziness | 4 (1.9) | 8 (3.0) | 3 (1.1) | 2 (0.7) |
Abbreviations: ER, extended release; TEAE, treatment-emergent adverse event.
a
A TEAE was defined as an adverse event with an onset date on or after the first dose of study drug was administered until 14 days after the last dose of study drug was administered. The follow-up period of at least 14 days (and ≤18 days) began when participants completed the 30-night treatment period.