Table 3.
Summary of Exploratory Efficacy Endpoints (Full Analysis Set)a
| PSG endpoints a | Night 1 | Week 4 | ||||||
|---|---|---|---|---|---|---|---|---|
| 2.5 mg | 5 mg | 10 mg | 20 mg | 2.5 mg | 5 mg | 10 mg | 20 mg | |
| TST, min | 40.4 (25.4, 55.3)b | 48.1 (33.1, 63.1)b | 53.1 (38.3, 67.9)b | 64.2 (49.4, 78.9)b | 23.4 (9.9, 37.0)b | 19.9 (6.4, 33.5)c | 45.6 (32.1, 59.2)b | 42.2 (28.6. 55.9)b |
| NAW | 0.1 (-1.4, 1.6) | -1.2 (-2.8, 0.3) | -0.6 (-2.0, 0.9) | -3.0 (-4.4, -1.5)b | 1.3 (-0.2, 2.7) | -0.5 (-2.0, 0.9) | -0.5 (-1.9, 0.9) | 0.4 (-1.1, 1.8) |
| Sleep architecture | ||||||||
| Stage 1, min | 1.9 (-1.8, 5.6) | 2.7 (-1.0, 6.5) | 7.1 (3.4, 10.8)b | 1.8 (-1.9, 5.4) | 7.3 (3.3, 11.2)b | -0.2 (-4.1, 3.7) | 3.6 (-0.3, 7.6) | 3.1 (-0.8, 7.1) |
| Stage 1, % | -0.8 (-1.8, 0.3) | -0.7 (-1.7, 0.3) | 0.0 (-1.0, 1.0) | -1.6 (-2.6, -0.6)c | 0.9 (-0.3, 2.0) | -0.5 (-1.7, 0.6) | -0.8 (-1.9, 0.3) | -0.3 (-1.4, 0.8) |
| Stage 2, min | 15.8 (5.1, 26.5)c | 15.5 (4.8, 26.3)c | 20.0 (9.4, 30.6)b | 34.3 (23.7, 44.9)b | 13.8 (3.1, 24.5)d | 7.4 (-3.3, 18.0) | 24.0 (13.3, 34.8)b | 23.5 (12.8, 34.3)b |
| Stage 2, % | -2.0 (-3.7, -0.2)d | -3.3 (-5.1, -1.6)b | -3.2 (-4.9, -1.5)b | -1.2 (-2.9, 0.6) | -0.2 (-1.9, 1.6) | -1.1 (-2.8, 0.7) | -0.8 (-2.6, 0.9) | -0.1 (-1.8, 1.7) |
| SWS, min | 3.8 (-2.5, 10.1) | 11.1 (4.8, 17.3)b | 4.4 (-1.7, 10.5) | 7.8 (1.5, 14.2)d | 0.8 (-5.5, 7.1) | 1.4 (-4.9, 7.7) | 2.5 (-3.8, 8.9) | 3.5 (-3.2, 10.1) |
| SWS, % | -0.5 (-2.0, 1.1) | 1.3 (-0.3, 2.8) | -0.2 (-1.7, 1.3) | 0.0 (-1.5, 1.6) | -0.5 (-2.0, 1.1) | -0.2 (-1.7, 1.4) | -0.7 (-2.2, 0.9) | -0.4 (-2.1, 1.2) |
| REM, min | 19.1 (11.7, 26.5)b | 18.6 (11.2, 26.0) b | 22.3 (15.0, 29.6)b | 21.6 (14.4, 28.9)b | 0.8 (-5.5, 7.2) | 11.3 (4.9, 17.7)b | 16.3 (10.0, 22.7)b | 11.3 (4.9, 17.7)b |
| REM, % | 3.3 (1.7, 4.8)b | 2.5 (1.0, 4.1)b | 3.1 (1.6, 4.6)b | 2.6 (1.1, 4.1)b | -0.8 (-2.2, 0.6) | 1.5 (0.1, 2.9)d | 2.1 (0.7, 3.5)c | 0.6 (-0.8, 2.0) |
| Latency to REM, min | -14.0 (-28.4, 0.5) | -26.1 (-40.6, -11.5)b | -25.4 (-39.7, -11.1)b | -31.7 (-46.0, -17.5)b | -5.5 (-18.3, 7.3) | -10.6 (-23.4, 2.3) | -11.8 (-24.6, 1.0) | -25.6 (-38.4, -12.8)b |
| Patient-reported endpoints a | Week 1 | Week 4 | ||||||
| 2.5 mg | 5 mg | 10 mg | 20 mg | 2.5 mg | 5 mg | 10 mg | 20 mg | |
| Subjective sleep | ||||||||
| sTST, min | 5.3 (-6.1, 16.7) | 19.2 (7.6, 30.7)c | 20.1 (8.7, 31.5)b | 30.1 (19.1, 41.2)b | 14.1 (3.3, 25.0)d | 25.7 (14.7, 36.7)b | 30.7 (19.8, 41.6)b | 38.0 (27.4, 48.6)b |
| sTSO, min | -8.0 (-15.4, -0.6)d | -12.0 (-19.5, -4.5)c | -17.6 (-25.0, -10.2)b | -16.9 (-24.1, -9.7)b | -9.4 (-16.0, -2.7)c | -14.0 (-20.8, -7.3)b | -17.1 (-23.8, -10.5)b | -18.2 (-24.7, -11.7)b |
| sQual, 4-point scalee | 0.1 (0.0, 0.2) | 0.1 (0.0, 0.3)d | 0.2 (0.1, 0.4)b | 0.2 (0.1, 0.3)b | 0.1 (0.0, 0.2) | 0.2 (0.1, 0.4)b | 0.3 (0.2, 0.4)b | 0.3 (0.2, 0.4)b |
| sFresh, 5-point scalef | 0.1 (-0.1, 0.2) | 0.2 (0.0, 0.3)d | 0.2 (0.0, 0.4)d | 0.2 (0.0, 0.3)d | 0.1 (0.0, 0.3) | 0.2 (0.0, 0.4)d | 0.3 (0.1, 0.4)c | 0.3 (0.1, 0.4)c |
| ISI | ||||||||
| Total score | - | - | - | - | -1.5 (-2.6, -0.4)c | -2.3 (-3.3, -1.2)b | -3.0 (-4.1, -2.0)b | -3.4 (-4.4, -2.3)b |
| SDS | ||||||||
| Total score | - | - | - | - | -1.1 (-2.5, 0.2) | -1.4 (-2.7, -0.1)d | -1.8 (-3.1, -0.4)c | -1.8 (-3.1, -0.5)c |
| Work | - | - | - | - | -0.2 (-0.7, 0.3) | -0.5 (-1.0, 0.0)d | -0.4 (-0.9, 0.1) | -0.6 (-1.1, -0.1)d |
| Social | - | - | - | - | -0.4 (-0.9, 0.1) | -0.3 (-0.8, 0.1) | -0.6 (-1.0, -0.1)d | -0.6 (-1.1, -0.1)d |
| Family | - | - | - | - | -0.1 (-0.6, 0.4) | -0.6 (-1.1, -0.1)d | -0.7 (-1.2, -0.2)c | -0.5 (-1.0, 0.0)d |
Abbreviations: CI, confidence interval; ISI, Insomnia Severity Index; NAW, number of awakenings after onset of persistent sleep; REM, rapid eye movement; SDS, Sheehan Disability Scale; sFresh, patient-reported freshness of sleep; sQual, patient-reported quality of sleep; sTSO, subjective time to sleep onset; sTST, subjective total sleep time; SWS, slow-wave sleep (stage 3 and 4); TSO, time to sleep onset; TST, total sleep time; VAS, visual analog scale.
aData presented are difference (95% CI) between filorexant and placebo in least-squares mean changes from baseline.
b P≤.001.
c P≤.01.
d P≤.05 vs placebo.
eResponse options were: 1=poor, 2=fair, 3=good, 4=excellent, in response to the question, “How would you describe the quality of your sleep last night?”
fResponse options were: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely, in response to the question, “How refreshed do you feel this morning?”