TABLE 3.
Summary of Insomnia Severity Index total score and Fatigue Severity Scale total score endpoints in female participants 40-58 years of age
| Placebo (n = 90) | LEM5 (n = 82) | LEM10 (n = 108) | ||||
|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | |
| ISI (total score) | ||||||
| aseline | 90 | 19.3 (2.8) | 82 | 20.1 (3.0) | 108 | 19.5 (3.7) |
| Month 1 | 85 | 12.9 (5.1) | 80 | 14.0 (6.2) | 99 | 12.2 (6.1) |
| Change from baseline at month 1 | 85 | −6.4 (5.8) | 80 | −6.1 (5.3) | 99 | −7.4 (7.0) |
| Month 3 | 79 | 11.6 (5.3) | 69 | 12.1 (6.6) | 91 | 10.4 (6.1) |
| Change from baseline at month 3 | 79 | −7.4 (6.1) | 69 | −7.8 (6.2) | 91 | −9.3 (6.6) |
| Month 6 | 72 | 10.9 (5.4) | 65 | 10.1 (6.5) | 82 | 8.8 (5.9) |
| Change from baseline at month 6 | 72 | −8.3 (6.0) | 65 | −9.8 (6.2) | 82 | −10.7 (6.9) |
| LSM treatment difference: LEM-PBO (95% CI) | — | −0.5 (−2.5 to 1.4) | −1.8 (−3.6 to 0) | |||
| P | — | 0.5876 | 0.0558 | |||
| Month 9 | — | — | 57 | 9.3 (5.9) | 73 | 7.5 (5.5) |
| Change from baseline at month 9 | — | — | 57 | −10.5 (5.8) | 73 | −12.0 (6.3) |
| Month 12 | — | — | 52 | 7.9 (6.1) | 70 | 7.7 (5.6) |
| Change from baseline at month 12 | — | — | 52 | −11.8 (5.8) | 70 | −11.6 (6.3) |
| FSS (total score) | ||||||
| aseline | 90 | 35.5 (14.0) | 82 | 39.8 (12.6) | 108 | 36.6 (13.5) |
| Month 1 | 85 | 30.9 (13.7) | 80 | 35.0 (13.0) | 99 | 30.1 (14.0) |
| Change from baseline at month 1 | 85 | −4.6 (12.4) | 80 | −4.7 (12.2) | 99 | −6.4 (13.7) |
| Month 3 | 79 | 30.1 (12.8) | 69 | 33.5 (13.9) | 91 | 28.9 (14.5) |
| Change from baseline at month 3 | 79 | −5.2 (11.3) | 69 | −6.3 (10.7) | 91 | −7.5 (13.4) |
| Month 6 | 72 | 28.5 (14.2) | 65 | 29.8 (14.8) | 82 | 27.1 (14.3) |
| Change from baseline at month 6 | 72 | −7.4 (12.8) | 65 | −9.9 (12.9) | 82 | −9.0 (14.5) |
| LSM treatment difference: LEM-PBO (95% CI) | −0.4 (−4.4 to 3.7) | −1.4 (−5.2 to 2.4) | ||||
| P | 0.8520 | 0.4677 | ||||
| Month 9 | — | — | 57 | 29.0 (13.0) | 73 | 23.8 (13.2) |
| Change from baseline at month 9 | — | — | 57 | −11.4 (12.5) | 73 | −11.1 (14.6) |
| Month 12 | — | — | 52 | 25.6 (12.6) | 70 | 25.1 (14.2) |
| Change from baseline at month 12 | — | — | 52 | −14.5 (13.1) | 70 | −9.8 (15.7) |
FSS, Fatigue Severity Scale; ISI, Insomnia Severity Index; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; PBO, placebo; SD, standard deviation.