Table 4.
Sleep diary parameters in the low excretors.
| Treatment effects | |||||
|---|---|---|---|---|---|
| Change from baseline Mean (SD) |
Short term | Long term * | |||
| Visit 3 | Visit 7 | Estimate (95% CI) P-value |
Estimate (95% CI) P-value |
||
| NMAX | PRM | 86 | 99 | ||
| Placebo | 86 | 31 | |||
| Sleep latency | PRM | -9.0 (50.5) | -23.6 (42.1) | -0.6 (-14.0, 12.7) | -6.7 (-16.4, 3.0) |
| (min) | Placebo | -9.0 (48.7) | -19.4 (79.5) | P = 0.924 | P = 0.174 |
| Sleep | PRM | -0.27 (0.77) | -0.31 (1.08) | -0.16 (-0.39, 0.08) | -0.04 (-0.24, 0.16) |
| maintenance | Placebo | -0.12 (1.04) | -0.34 (0.71) | P = 0.185 | P = 0.677 |
| Total sleep | PRM | 0.34 (0.88) | 0.70 (1.00) | 9.1 (-6.1, 24.4) | 13.1 (1.0, 25.2) |
| time (h) | Placebo | 0.20 (0.91) | 0.47 (1.18) | P = 0.236 | P = 0.035 |
| Sleep onset | PRM | -0.15 (0.89) | -0.46 (0.79) | -0.08 (-0.33, 0.17) | -0.16 (-0.34, 0.03) |
| (h) | Placebo | -0.05 (0.80) | -0.24 (1.11) | P = 0.530 | P = 0.096 |
| Sleep offset | PRM | 0.09 (0.79) | 0.08 (0.84) | 0.04 (-0.18, 0.25) | 0.07 (-0.09, 0.22) |
| (h) | Placebo | 0.10 (0.75) | 0.20 (1.00) | P = 0.744 | P = 0.392 |
| Refreshed on | PRM | -0.09 (0.46) | -0.23 (0.43) | -0.01 (-0.13, 0.11) | -0.03 (-0.12, 0.06) |
| waking | Placebo | -0.09 (0.40) | -0.29 (0.47) | P = 0.830 | P = 0.540 |
| Morning | PRM | -0.14 (0.67) | -0.42 (0.65) | 0.01 (-0.18, 0.19) | -0.06 (-0.19, 0.08) |
| alertness | Placebo | -0.19 (0.63) | -0.35 (0.73) | P = 0.936 | P = 0.426 |
| Sleep quality | PRM | -0.20 (0.67) | -0.43 (0.70) | -0.04 (-0.24, 0.16) | -0.08 (-0.23, 0.06) |
| Placebo | -0.16 (0.70) | -0.34 (0.60) | P = 0.688 | P = 0.266 | |
*The global treatment effect is estimated using a mixed-effect model for repeated measures and takes into account the treatment effect difference over the 26-weeks (at Visits 3, 4, 5, 6 and 7) sleep latency (diary data) are repeated for completeness
C, confidence interval; SD, standard deviation; PRM, prolonged release melatonin.