Table 2.
Sleep diary variables at baseline and change from baseline at month 6 (full analysis set)
| PBO (n = 318) | LEM5 (n = 316) | LEM10 (n = 315) | |
|---|---|---|---|
| sSOL, min | |||
| Median (1st and 3rd Quartiles) baseline* | 55.86 (34.14, 78.93) | 53.57 (32.86, 75.71) | 55.71 (33.57, 85.07) |
| Median (1st and 3rd Quartiles) at month 6† | 34.29 (16.43, 60.00) | 22.29 (12.86, 35.43) | 23.57 (12.86, 40.71) |
| Median (1st and 3rd Quartiles) change from baseline at month 6‡ | −11.43 (−33.57, 0.00) | −21.81 (−44.29, −11.14) | −28.21 (−54.43, −9.29) |
| LSGM ratio (95% CI)‡ | 0.618 (0.559–0.684) | 0.453 (0.408–0.502) | 0.433 (0.389–0.483) |
| LSGM treatment ratio (95% CI)‡ | 0.732 (0.636–0.843) | 0.701 (0.607–0.810) | |
| p value | <0.0001 | <0.0001 | |
| sSE, % | |||
| Mean (SD) baseline§ | 61.34 (17.84) | 63.14 (18.23) | 62.03 (17.25) |
| Mean (SD) at month 6|| | 71.40 (18.31) | 78.55 (16.24) | 76.53 (17.99) |
| LSM (SE) change from baseline at month 6¶ | 9.64 (0.84) | 14.19 (0.86) | 14.31 (0.87) |
| LSM (SE) treatment difference at month 6¶ | 4.55 (1.18) | 4.67 (1.17) | |
| p value | 0.0001 | <0.0001 | |
| sWASO, min | |||
| Mean (SD) baseline# | 132.49 (80.20) | 132.77 (82.52) | 136.83 (87.39) |
| Mean (SD) at month 6** | 103.15 (82.29) | 81.79 (76.80) | 86.38 (77.79) |
| LSM (SE) change from baseline at month 6†† | −29.28 (3.61) | −46.75 (3.66) | −41.95 (3.69) |
| LSM (SE) treatment difference at month 6†† | −17.47 (5.01) | −12.67 (4.95) | |
| p value | 0.0005 | 0.0105 | |
| sTST, min | |||
| Mean (SD) baseline§ | 304.25 (91.46) | 315.52 (93.50) | 306.89 (88.03) |
| Mean (SD) at month 6|| | 356.03 (95.37) | 392.08 (86.95) | 379.25 (95.38) |
| LSM (SE) change from baseline at month 6¶ | 51.40 (4.60) | 69.95 (4.66) | 74.08 (4.76) |
| LSM (SE) treatment difference at month 6¶ | 18.56 (6.32) | 22.69 (6.39) | |
| p value | 0.0034 | 0.0004 | |
| Quality of sleep rating | |||
| Mean (SD) baseline* | 3.8 (1.4) | 4.0 (1.3) | 4.0 (1.4) |
| Mean (SD) at month 6† | 4.8 (1.7) | 5.2 (1.5) | 5.2 (1.7) |
| LSM (SE) change from baseline at month 6‡ | 0.9 (0.1) | 1.2 (0.1) | 1.2 (0.1) |
| LSM (SE) treatment difference at month 6‡ | 0.28 (0.12) | 0.32 (0.12) | |
| p value | 0.0244 | 0.0103 | |
| Morning alertness rating | |||
| Mean (SD) baseline* | 3.94 (1.56) | 3.93 (1.35) | 3.93 (1.32) |
| Mean (SD) at month 6† | 4.76 (1.66) | 4.96 (1.60) | 4.99 (1.67) |
| LSM (SE) change from baseline at month 6‡ | 0.78 (0.09) | 0.93 (0.09) | 1.04 (0.09) |
| LSM (SE) treatment difference at month 6‡ | 0.14 (0.12) | 0.26 (0.12) | |
| p value | 0.2248 | 0.0298 |
sSOL values were log-transformed and statistical comparisons made using the LSGM. p values are based on the mixed-effect repeated measures model evaluating the LSGM treatment ratio between PBO and LEM. For other variables, p values are based on the mixed-effect repeated measures model evaluating the LSM treatment difference between PBO and LEM. CI, confidence interval; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; LSGM, least-squares geometric mean; LSM, least-squares mean; PBO, placebo; SD, standard deviation; SE, standard error; sSE, subjective sleep efficiency; sSOL, subjective sleep onset latency; sTST, subjective total sleep time; sWASO, subjective wake after sleep onset.
*n = 316 for PBO, n = 314 for LEM5, n = 312 for LEM10.
† n = 251 for PBO, n =247 for LEM5, n = 230 for LEM10.
‡ n = 249 for PBO, n = 245 for LEM5, n = 229 for LEM10.
§ n = 307 for PBO, n = 302 for LEM5, n = 299 for LEM10.
|| n = 247 for PBO, n = 245 for LEM5, n = 228 for LEM10.
¶ n = 242 for PBO, n = 235 for LEM5, n = 220 for LEM10.
# n = 314 for PBO, n = 313 for LEM5, n = 311 for LEM10.
** n = 251 for PBO, n = 247 for LEM5, n = 229 for LEM10.
†† n = 248 for PBO, n = 244 for LEM5, n = 227 for LEM10.