Change from baseline in objective polysomnographic measures at Week 8 (patients who completed the study). All data reported as mean (SD).
| Placebo | Sodium Oxybate 4.5 g | p vs Placebo | Sodium Oxybate 6 g | p vs Placebo | |
|---|---|---|---|---|---|
| No. patients | 54 | 51 | 46 | ||
| Sleep/wake measures | (n = 52) | (n = 46) | (n = 40) | ||
| Total sleep time, min | 10.1 (76.0) | –11.4 (52.3) | 0.134 | 39.4 (79.1) | 0.050 |
| Sleep onset latency, min | 0.9 (46.9) | 3.2 (23.0) | 0.760 | –5.9 (36.9) | 0.394 |
| Wake after sleep onset, min | –16.2 (46.3) | 4.2 (46.3) | 0.053 | –39.7 (62.0) | 0.032 |
| No. awakenings | –4.3 (12.9) | –5.4 (8.5) | 0.660 | –7.1 (12.5) | 0.268 |
| Sleep efficiency, % | 3.0 (16.0) | –2.4 (11.1) | 0.068 | 8.9 (15.3) | 0.052 |
| Sleep stages | (n = 52) | (n = 45) | (n = 39) | ||
| Rapid eye movement (REM), min | –2.3 (32.6) | –23.8 (32.2) | 0.003 | –18.6 (39.0) | 0.027 |
| Non-REM, min | 12.4 (61.2) | 12.4 (56.0) | 0.996 | 57.9 (70.9) | < 0.001 |
| Stage 1, min | –4.0 (23.6) | –6.1 (21.5) | 0.673 | –8.9 (28.7) | 0.345 |
| Stage 2, min | 18.1 (60.5) | 4.9 (59.8) | 0.309 | 47.5 (70.5) | 0.030 |
| Slow-wave sleep, min | –1.7 (34.0) | 13.6 (49.2) | 0.091 | 19.4 (49.8) | 0.026 |
| Rate of cyclic alternating pattern (CAP) | (n = 20) | (n = 14) | (n = 13) | ||
| Phase A1 CAP rate, % | –0.1 (11.2) | 5.8 (9.2) | 0.172 | 7.0 (16.2) | 0.108 |
| Phase A2/A3 CAP rate, % | –0.4 (3.5) | –2.1 (3.2) | 0.180 | –3.9 (3.7) | 0.007 |