TABLE 7.
Treatment discontinuation and individual adverse events for lemborexant 5 vs. placebo.
| Adverse events | N | No. of cases (lemborexant 5/placebo) | RR | 95% CI | P-value | I2, % |
| Discontinuation due to all cause | 2 | 589/534 | 1.02 | 0.76, 1.37 | 0.91 | 20 |
| Discontinuation due to intolerability | 2 | 589/534 | 1.06 | 0.45, 2.46 | 0.90 | 0 |
| Any TEAE | 3 | 618/584 | 1.01 | 0.90, 1.13 | 0.86 | 0 |
| Any treatment-related TEAE | 3 | 618/584 | 1.69 | 1.29, 2.22 | 0.0001 | 0 |
| Any severe TEAE | 2 | 580/528 | 1.05 | 0.50, 2.20 | 0.89 | 43 |
| Any serious TEAE | 3 | 618/584 | 1.46 | 0.55, 3.90 | 0.45 | 0 |
| Any TEAE leading to discontinuation of study drug | 3 | 618/584 | 1.05 | 0.51, 2.15 | 0.89 | 0 |
| Any TEAE leading to interruption of study drug | 2 | 580/528 | 1.73 | 0.74, 4.07 | 0.21 | 0 |
| Death | 2 | 580/528 | Not estimable | – | − | – |
| Somnolence | 3 | 618/584 | 4.05 | 2.14, 8.06 | <0.0001 | 0 |
| Headache | 3 | 618/584 | 1.24 | 0.82, 1.87 | 0.31 | 0 |
| Upper respiratory tract infection | 2 | 580/528 | 1.28 | 0.65, 2.52 | 0.48 | 0 |
| Back pain | 2 | 352/375 | 0.68 | 0.28, 1.63 | 0.39 | – |
| Urinary tract infection | 2 | 580/528 | 0.73 | 0.27, 1.96 | 0.53 | 0 |
| Nightmare | 2 | 352/375 | 4.16 | 0.69, 25.20 | 0.12 | 0 |
| Abnormal dreams | 2 | 352/375 | 1.39 | 0.51, 3.78 | 0.52 | 0 |
| Dizziness | 2 | 304/365 | 0.59 | 0.13, 2.60 | 0.49 | – |
95% CI, 95% confidence interval; N, number of comparisons/studies; RR, risk ratio; TEAE, treatment-emergent adverse event. 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.