Table 1.
Measure | Placebo Mean ± SD | Ramelteon Mean ± SD | Effect Size | p value |
---|---|---|---|---|
Sleep efficiency % | 83.3 ± 14.3 | 89.1 ± 9.8 | 0.1725 | |
Sleep latency (min) | 20.3 ± 17.5 | 13.6 ± 11.9 | 0.1971 | |
Total sleep time (min) | 100.3 ± 17.5 | 106.8 ± 12.1 | 0.2016 | |
Stage 1 (%) | 5.4 ± 2.0 | 6.8 ± 5.9 | 0.3549 | |
Stage 2 (%) | 36.8 ± 12.8 | 47.1 ± 15.9 | 0.0502 | |
Stage 3&4 (slow wave sleep)(%) | 34.1 ± 6.0 | 30.4 ± 16.5 | 0.3759 | |
Stage REM (%) | 7.0 ± 9.7 | 4.9 ± 7.9 | 0.2276 | |
Wake (%) | 16.6 ± 14.3 | 10.9 ± 9.8 | 0.1747 | |
Awakenings | 3.6 ± 3.0 | 10.9 ± 9.8 | 1.01 | 0.0193*** |
Secondary endpoints uncorrected α*** = p < 0.05