TABLE 2.
Summary of sleep diary endpoints in female participants 40-58 years of age
| Placebo (n = 90) |
LEM5 (n = 82) |
LEM10 (n = 108) |
||||
|---|---|---|---|---|---|---|
| sSOL, min | n | Median (1st and 3rd quartiles) | n | Median (1st and 3rd quartiles) | n | Median (1st and 3rd quartiles) |
| Baseline | 90 | 57.5 (35.7, 79.6) | 82 | 51.1 (31.4, 73.6) | 105 | 54.0 (37.9, 80.8) |
| Week 1 | 89 | 49.3 (28.8, 74.5) | 80 | 33.3 (20.4, 59.9) | 107 | 37.9 (22.9, 61.6) |
| Change from baseline at week 1 | 89 | −5.7 (−21.4, 4.1) | 80 | −11.1 (−26.4, 0.0) | 104 | −12.9 (−30.0, −0.6) |
| Month 3 | 82 | 29.5 (15.7, 57.0) | 67 | 20.7 (14.3, 40.0) | 92 | 24.1 (13.6, 39.8) |
| Change from baseline at month 3 | 82 | −17.6 (−32.1, −3.0) | 67 | −18.6 (−41.6, −6.7) | 90 | −29.3 (−49.9, −13.3) |
| Month 6 | 71 | 24.3 (14.0, 51.4) | 63 | 20.7 (11.7, 33.6) | 77 | 20.0 (10.0, 32.1) |
| Change from baseline at month 6 | 71 | −17.9 (−40.0, −2.9) | 63 | −20.7 (−39.1, −10.3) | 76 | −30.4 (−55.0, −17.6) |
| LSGM treatment ratio: LEM/PBO (95% CI) | — | 0.87 (0.65 to 1.16) | 0.74 (0.57 to 0.97) | |||
| P | — | 0.3464 | 0.0310 | |||
| Month 9 | — | 57 | 20.0 (10.0, 34.2) | 73 | 19.2 (10.0, 40.7) | |
| Change from baseline at month 6 | — | 57 | −23.6 (−46.4, −10.7) | 72 | −32.8 (−52.8, −21.2) | |
| Month 12 | — | 49 | 19.2 (10.7, 29.4) | 73 | 15.8 (10.0, 34.3) | |
| Change from baseline at month 6 | — | 49 | −27.7 (−46.4, −13.3) | 72 | −33.9 (−55.7, −19.7) | |
| sSE, % | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) |
|---|---|---|---|---|---|---|
| Baseline | 88 | 59.9 (16.7) | 80 | 60.7 (20.0) | 102 | 61.2 (17.5) |
| Week 1 | 85 | 63.4 (18.0) | 79 | 67.9 (20.3) | 105 | 68.8 (17.8) |
| Change from baseline at week 1 | 85 | 3.0 (11.8) | 78 | 6.9 (10.5) | 101 | 7.4 (10.3) |
| Month 3 | 80 | 74.0 (16.7) | 65 | 77.9 (16.0) | 91 | 75.1 (17.4) |
| Change from baseline at month 3 | 79 | 13.0 (14.3) | 65 | 15.1 (15.8) | 86 | 14.3 (13.5) |
| Month 6 | 71 | 72.8 (19.3) | 63 | 78.3 (16.3) | 77 | 78.0 (17.8) |
| Change from baseline at month 6 | 70 | 12.5 (15.0) | 62 | 15.9 (17.0) | 73 | 17.2 (14.7) |
| LSM treatment difference: LEM-PBO (95% CI) | — | 2.19 (−2.36 to 6.74) | 3.28 (−1.11 to 7.67) | |||
| P | — | 0.3463 | 0.1428 | |||
| Month 9 | — | 57 | 78.6 (17.7) | 73 | 78.9 (16.9) | |
| Change from baseline at month 6 | — | 56 | 16.1 (19.5) | 69 | 17.9 (15.6) | |
| Month 12 | — | 49 | 82.1 (11.2) | 73 | 79.8 (16.7) | |
| Change from baseline at month 6 | — | 49 | 17.6 (18.2) | 69 | 19.1 (14.8) |
| sWASO, min | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) |
|---|---|---|---|---|---|---|
| Baseline | 90 | 134.9 (70.8) | 82 | 142.4 (86.5) | 105 | 136.5 (84.4) |
| Week 1 | 89 | 135.5 (90.2) | 80 | 120.7 (90.1) | 107 | 117.7 (82.8) |
| Change from baseline at week 1 | 89 | 0.7 (56.3) | 80 | −21.4 (43.7) | 104 | −17.9 (44.5) |
| Month 3 | 82 | 97.2 (83.4) | 67 | 87.5 (80.6) | 92 | 96.9 (86.9) |
| Change from baseline at month 3 | 82 | −37.3 (60.3) | 67 | −49.7 (67.7) | 90 | −38.6 (66.0) |
| Month 6 | 71 | 95.0 (74.8) | 63 | 83.8 (73.4) | 77 | 83.1 (79.7) |
| Change from baseline at month 6 | 71 | −37.0 (59.6) | 63 | −50.1 (74.5) | 76 | −54.5 (65.4) |
| LSM treatment difference: LEM-PBO (95% CI) | — | −12.43 (−31.95 to 7.09) | −9.94 (−28.18 to 8.30) | |||
| P | — | 0.2119 | 0.2853 | |||
| Month 9 | — | 57 | 79.7 (78.9) | 73 | 77.3 (73.9) | |
| Change from baseline at month 6 | — | 57 | −54.7 (86.9) | 72 | −59.5 (74.6) | |
| Month 12 | — | 49 | 65.8 (52.5) | 73 | 73.9 (69.7) | |
| Change from baseline at month 6 | — | 49 | −59.1 (76.7) | 72 | −66.2 (64.9) |
| sTST, min | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) |
|---|---|---|---|---|---|---|
| Baseline | 88 | 294.9 (83.9) | 80 | 300.6 (101.5) | 102 | 302.6 (90.5) |
| Week 1 | 85 | 316.5 (89.8) | 79 | 338.9 (103.2) | 105 | 343.8 (92.8) |
| Change from baseline at week 1 | 85 | 19.2 (60.4) | 78 | 35.9 (53.0) | 101 | 40.0 (55.1) |
| Month 3 | 80 | 369.0 (94.8) | 65 | 386.7 (85.2) | 91 | 374.8 (93.9) |
| Change from baseline at month 3 | 79 | 68.9 (88.7) | 65 | 76.2 (80.2) | 86 | 74.3 (72.8) |
| Month 6 | 71 | 354.0 (97.5) | 63 | 389.6 (83.4) | 77 | 391.0 (97.5) |
| Change from baseline at month 6 | 70 | 59.9 (80.4) | 62 | 80.6 (87.9) | 73 | 90.6 (80.1) |
| LSM treatment difference: LEM-PBO (95% CI) | — | 11.23 (−14.42 to 36.87) | 24.07 (−0.33 to 48.47) | |||
| P | — | 0.3892 | 0.0531 | |||
| Month 9 | — | 57 | 384.2 (92.3) | 73 | 389.8 (88.8) | |
| Change from baseline at month 6 | — | 56 | 73.9 (98.5) | 69 | 86.3 (79.0) | |
| Month 12 | — | 49 | 398.8 (58.2) | 73 | 391.5 (90.5) | |
| Change from baseline at month 6 | — | 49 | 78.1 (93.6) | 69 | 91.6 (77.3) |
CI, confidence interval; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; LSGM, least squares geometric mean; LSM, least squares mean; PBO, placebo, sSE, subjective sleep efficiency; sSOL, subjective sleep-onset latency; sTST, subjective total sleep time; sWASO, subjective wake after sleep onset.