Table 2.
Results of an ANCOVA Analysis Evaluating the Efficacy of Indiplon vs. Placebo on Primary and Secondary Sleep Parameters (intent to treat): LS mean ± SE
| Placebo | Indiplon 10 mg | Indiplon 20 mg | Significance testing, Indiplon vs. placebo |
||||
|---|---|---|---|---|---|---|---|
| N=86 | N=84 | N=90 | 10 mg |
20 mg |
|||
| t | P | t | P | ||||
| LSOpd, min | |||||||
| Baseline | 58.9 ± 2.7 | 59.3 ± 2.8 | 64.8 ± 3.0 | ||||
| 4-week average | 45.2 ± 2.2 | 36.5 ± 1.8 | 34.4 ± 1.7 | −3.08 | 0.0023 | −3.96 | <0.0001 |
| sWASOpd, min | |||||||
| Baseline | 27.5 ± 4.6 | 31.7 ± 4.7 | 37.7 ± 4.6 | ||||
| 4-week average | 24.4 ± 3.5 | 16.2 ± 3.6 | 12.0 ± 3.5 | −1.65 | 0.1000 | −2.52 | 0.0122 |
| sNAASOpd | |||||||
| Baseline | 1.22 ± 0.14 | 1.44 ± 0.15 | 1.48 ± 0.14 | ||||
| 4-week average | 0.85 ± 0.09 | 0.74 ± 0.09 | 0.54 ± 0.09 | −0.90 | 0.3712 | −2.52 | 0.0125 |
| sTSTpd, min | |||||||
| Baseline | 204 ± 8.4 | 203 ± 8.5 | 198 ± 8.2 | ||||
| 4-week average | 229 ± 6.6 | 253 ± 6.8 | 278 ± 6.5 | 2.60 | 0.0099 | 5.28 | <0.0001 |
| Sleep Quality | |||||||
| Baseline | 4.2 ± 0.1 | 4.3 ± 0.1 | 4.3 ± 0.1 | ||||
| 4-week average | 3.8 ± 0.1 | 3.3 ± 0.1 | 3.0 ± 0.1 | −3.44 | 0.0007 | −5.83 | <0.0001 |
All values are reported as LS means ± standard error of the mean (SE) 4-week average LS means are from an ANCOVA model with baseline values used as a covariate. For LSOpd the ANCOVA was performed on log-transformed data, and then antilog transformed.