Table 2.
Group mean* measures of insomnia symptoms and sleep quantity and quality at baseline and during ZTL-101 and placebo dosing (n = 23)
| Baseline | ZTL-101 | Placebo | p † | Effect size‡ d |
|
|---|---|---|---|---|---|
| Insomnia symptoms | |||||
| ISI (score) | 18.0 ± 3.7 | 12.9 ± 5.3 | 18.0 ± 4.3 | 0.0001 | 0.94 |
| Self-reported measures—sleep diary | |||||
| sSOL (min) | 47.6 ± 38.0 | 38.1 ± 28.0 | 46.9 ± 34.4 | 0.0369 | 0.44 |
| sTST (min) | 300.5 ± 82.6 | 366.7 ± 74.5 | 304.1 ± 81.0 | <0.001 | 1.27 |
| sSQ§ | 2.5 ± 0.5 | 3.2 ± 0.6 | 2.5 ± 0.5 | <0.001 | 1.37 |
| Rested on waking‖ | 1.2 ± 0.4 | 1.8 ± 0.6 | 1.2 ± 0.5 | 0.0007 | 0.83 |
| Actigraphy | |||||
| aSOL (min) | 4.7 ± 1.3 | 4.8 ± 0.9 | 5.2 ± 1.9 | 0.2825 | 0.22 |
| aWASO (min) | 84.3 ± 23.2 | 71.8 ± 23.9 | 82.3 ± 27.7 | 0.0021 | 0.68 |
| aTST (min) | 398.9 ± 33.8 | 424.7 ± 34.7 | 391.2 ± 35.5 | <0.001 | 1.44 |
| aSE (%) | 81.8 ± 4.3 | 84.8 ± 4.3 | 81.9 ± 4.9 | <0.001 | 1.28 |
| aAI (n) | 24.8 ± 5.8 | 23.4 ± 6.0 | 23.6 ± 6.2 | 0.1236 | 0.03 |
| PSG | |||||
| SOL (min) | 12.3 ± 11.4 | 25.5 ± 22.0 | 25.4 ± 52.7 | 0.9743 | 0.00 |
| WASO (min) | 108.8 ± 49.5 | 96.2 ± 65.9 | 82.0 ± 51.0 | 0.1872 | 0.26 |
| TST (min) | 375.0 ± 68.4 | 384.3 ± 82.0 | 386.9 ± 72.0 | 0.8396 | 0.03 |
| SE (%) | 75.6 ± 10.6 | 75.8 ± 14.2 | 78.0 ± 12.7 | 0.4124 | 0.15 |
| AI (n) | 23.0 ± 8.7 | 22.7 ± 8.2 | 18.4 ± 5.6 | 0.0709 | 0.40 |
*Unadjusted mean ± SD.
† p-value based on linear mixed model analysis of treatment responses for ZTL-101 vs placebo.
‡Effect size for ZTL-101 vs placebo.
§Rating of sleep quality 0 = very poor, 1 = poor, 2 = fair, 3 = good, 4 = very good.
‖Rating of feeling rested/refreshed upon waking 0 = not at all rested, 1 = slightly rested, 2 = somewhat rested, 3 = well-rested, 4 = very well-rested.