Table 2.
Patients’ demographic characteristics.
| Study 303 |
Study 304 |
|||||
|---|---|---|---|---|---|---|
| PBO (n = 318) | LEM5 (n = 316) | LEM10 (n = 315) | PBO (n = 208) | LEM5 (n = 266) | LEM10 (n = 269) | |
| Age, y | ||||||
| Mean (SD) | 54.5 (14.0) | 54.2 (13.7) | 54.8 (13.7) | 63.4 (6.4) | 63.7 (6.8) | 64.2 (6.9) |
| Median (range) | 56.0 (18–83) | 55.0 (20–85) | 55.0 (18–88) | 62 (55–82) | 63 (55–88) | 64 (55–85) |
| ≥65 [n (%)] | 89 (28.0) | 87 (27.5) | 86 (27.3) | 93 (44.7) | 118 (44.4) | 122 (45.4) |
| Sex, female [n (%)] | 216 (67.9) | 209 (66.1) | 222 (70.5) | 184 (88.5) | 229 (86.1) | 230 (85.5) |
| Race [n (%)] | ||||||
| White | 232 (73.0) | 222 (70.3) | 225 (71.4) | 153 (73.6) | 199 (74.8) | 202 (75.1) |
| African American | 23 (7.2) | 27 (8.5) | 26 (8.3) | 51 (24.5) | 63 (23.7) | 62 (23.0) |
| Japanese | 54 (17.0) | 53 (16.8) | 54 (17.1) | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Other Asian | 5 (1.6) | 8 (2.5) | 4 (1.3) | 1 (0.5) | 2 (0.8) | 5 (1.9) |
| Others | 4 (1.3) | 6 (1.9) | 6 (1.9) | 2 (1.0) | 2 (0.8) | 0 (0.0) |
| BMI, mean (SD), kg/m2 | 27.2 (5.5) | 27.3 (6.3) | 27.2 (5.6) | 27.5 (5.1) | 27.4 (4.7) | 27.3 (4.6) |
| Subjective sleep parameter | ||||||
| sSOL, min [Mean (SD)] | 64.0 (45.2) | 62.2 (45.7) | 65.0 (44.0) | 55.9 (37.4) | 65.8 (43.5) | 60.9 (42.5) |
| sSE, % [Mean (SD)] | 61.3 (17.8) | 63.1 (18.2) | 62.0 (17.2) | 56.1 (17.3) | 56.1 (17.1) | 54.3 (18.3) |
| sWASO, min [Mean (SD)] | 132.5 (80.2) | 132.8 (82.5) | 136.8 (87.4) | 170.9 (80.7) | 166.8 (82.0) | 175.4 (83.5) |
| sTST, min [Mean (SD)] | 304.3 (91.5) | 315.5 (93.5) | 306.9 (88.0) | 276.2 (87.6) | 275.7 (83.7) | 266.1 (92.2) |
| sQual [Mean (SD)] | 3.84 (1.44) | 3.94 (1.27) | 3.92 (1.35) | 3.87 (1.43) | 3.78 (1.35) | 3.70 (1.31) |
| Morning alertness [Mean (SD)] | 3.94 (1.56) | 3.93 (1.35) | 3.93 (1.32) | 4.15 (1.49) | 4.14 (1.49) | 3.99 (1.45) |
| Objective sleep parameter | ||||||
| LPS, min [Mean (SD)] | ― | ― | ― | 43.9 (33.6) | 44.9 (36.5) | 44.6 (33.0) |
| SE, % [Mean (SD)] | ― | ― | ― | 68.9 (9.6) | 68.4 (11.3) | 67.9 (10.8) |
| WASO, min [Mean (SD)] | ― | ― | ― | 111.8 (37.2) | 113.4 (39.0) | 114.8 (40.0) |
| TST, min [Mean (SD)] | ― | ― | ― | 330.7 (46.3) | 328.0 (54.2) | 325.1 (52.8) |
| ISI total score [Mean (SD)] | 19.0 (3.1) | 19.6 (3.3) | 19.1 (3.4) | 19.4 (3.6) | 18.9 (3.5) | 19.0 (3.3) |
| ISI daytime function [Mean (SD)] | 11.0 (2.1) | 11.4 (2.0) | 11.1 (2.2) | 11.2 (2.4) | 10.9 (2.4) | 10.8 (2.3) |
| FSS total score [Mean (SD)] | 35.2 (13.6) | 37.4 (12.7) | 36.0 (13.0) | 37.5 (13.6) | 37.5 (13.5) | 37.4 (13.1) |
BMI, body mass index; FSS, Fatigue Severity Scale; ISI, Insomnia Severity Index; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; LPS, latency to persistent sleep; PBO, placebo; SD, standard deviation; SE, sleep efficiency; SOL, sleep-onset latency; sQual, subjective sleep quality; sSE, subjective sleep efficiency; sSOL, subjective sleep-onset latency; sTST, subjective total sleep time; sWASO, subjective wake after sleep onset; TST, total sleep time; WASO, wake after sleep onset.