Table 2.
Primary and Secondary Outcomes
| Dimdazenil (n = 367) | Placebo (n = 178) | P-value | |
|---|---|---|---|
| Primary endpoints | |||
| Day 13/14 TST, min | 406.68 (55.84) | 376.54 (58.85) | <0.001 |
| LSM difference compared with baseline (95% CI) | 32.05 (20.8333, 43.2682) | — | — |
| *p-value | <0.001 | — | — |
| Secondary endpoints | |||
| Day 13/14 LPS, min | 36.99 (32.62) | 42.87 (39.11) | 0.023 |
| LSM difference compared with baseline (95% CI) | −6.46 (−12.0424, −0.8783) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 SE, % | 79.91 (10.93) | 74.22 (11.80) | <0.001 |
| LSM difference compared with baseline (95% CI) | 5.55 (3.71, 7.39) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 WASO, min | 69.44 (52.56) | 93.02 (57.44) | <0.001 |
| LSM difference compared with baseline (95% CI) | −20.16 (−28.61, −11.71) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 sSL, min | 52.90 (30.30) | 54.66 (33.40) | 0.049 |
| LSM difference compared with baseline (95% CI) | −4.23 (−8.4318, −0.0238) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 sTST, min | 362.91 (59.61) | 347.28 (59.20) | <0.001 |
| LSM difference compared with baseline (95% CI) | 18.33 (10.09, 26.57) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 sWASO, min | 41.11 (38.73) | 57.66 (49.44) | <0.001 |
| LSM difference compared with baseline (95% CI) | −14.60 (−19.95, −9.24) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 sNAW | 1.35 (0.80) | 1.79 (1.11) | <0.001 |
| LSM difference compared with baseline (95% CI) | −0.29 (−0.4083, −0.1755) | — | — |
| *p-value | <0.001 | — | — |
| Day 13/14 ISI, score | 11.0 (5.09) | 12.6 (5.20) | <0.001 |
Variables expressed as mean (SD). CI, confidence interval; LSM, least squares mean; TST, total sleep time; LPS, latency to persistent sleep; SE, sleep efficiency; WASO, wake after sleep onset; sSL, subjective sleep latency; ISI, insomnia severity index. *Two-sided p-value versus baseline.