Table 3.
Percentage of subjects with long wake bouts (> 6 min) by treatment group and visits (phase III study)
| Visit | Patients n/N (%) |
Patients n/N (%) |
Difference in % | Logistic regression | ||
|---|---|---|---|---|---|---|
| Odds ratio | 95% CI | |||||
| Daridorexant 25 mg (active) | Placebo (comparator) | |||||
| Baseline | 1st night | 303/310 (97.74) | 300/309 (97.09) | 0.65 | ||
| 2nd night | 294/310 (94.84) | 296/309 (95.79) | − 0.95 | |||
| Month 1 | 1st night | 244/297 (82.15) | 279/297 (93.94) | − 11.78 | 3.44** | [1.96–6.05] |
| 2nd night | 252/297 (84.85) | 269/300 (89.67) | − 4.82 | 1.52 | [0.93–2.48] | |
| Month 3 | 1st night | 236/288 (81.94) | 260/282 (92.20) | − 10.25 | 2.64* | [1.56–4.47] |
| 2nd night | 219/289 (75.78) | 251/284 (88.38) | − 12.60 | 2.44** | [1.56–3.82] | |
| Visit | Patients n/N (%) |
Patients n/N (%) |
Difference in % | Logistic regression | ||
|---|---|---|---|---|---|---|
| Daridorexant 50 mg (active) | Placebo (comparator) | Odds ratio | 95% CI | |||
| Baseline | 1st night | 298/309 (96.44) | 300/309 (97.09) | − 0.65 | ||
| 2nd night | 298/309 (96.44) | 296/309 (95.79) | 0.65 | |||
| Month 1 | 1st night | 247/305 (80.98) | 279/297 (93.94) | − 12.96 | 3.68** | [2.10–6.46] |
| 2nd night | 229/302 (75.83) | 269/300 (89.67) | − 13.84 | 2.78** | [1.76–4.39] | |
| Month 3 | 1st night | 209/287 (72.82) | 260/282 (92.20) | − 19.38 | 4.41** | [2.66–7.33] |
| 2nd night | 213/284 (75.00) | 251/284 (88.38) | − 13.38 | 2.53** | [1.61–3.95] | |
Percentage of subjects with at least one wake bout > 6 min on each night for all treatment groups. Odds ratios > 1 benefit the active group; odds ratios < 1 benefit the comparator group
CI confidence interval, n number of subjects with long wake bouts, N patients with available PSG data on the night in question, PSG polysomnography
*p < 0.001 for active vs comparator group. **p < 0.0001 for active vs comparator group