Table 2.
Percentage of subjects with long wake bouts (> 6 min) by treatment group and visits (phase II study)
| Visit | Patients n/N (%) | Patients n/N (%) | Difference in % | Logistic regression | ||
|---|---|---|---|---|---|---|
| Odds ratio | 95% CI | |||||
| Daridorexant 50 mg (active) | Zolpidem 10 mg (comparator) | |||||
| Baseline | 1st night | 59/61 (96.72) | 58/60 (96.67) | 0.05 | ||
| 2nd night | 58/61 (95.08) | 56/60 (93.33) | 1.75 | |||
| Day 1/2 | 1st night | 35/60 (58.33) | 46/60 (76.67) | − 18.33 | 2.37* | [1.07–5.24] |
| 2nd night | 36/61 (59.02) | 52/60 (86.67) | − 27.65 | 4.80*** | [1.92–12.02] | |
| Day 28/29 | 1st night | 37/57 (64.91) | 47/59 (79.66) | − 14.75 | 2.15 | [0.93–4.98] |
| 2nd night | 34/57 (59.65) | 49/59 (83.05) | − 23.40 | 3.44** | [1.44–8.22] | |
| Visit | Patients n/N (%) | Patients n/N (%) | Difference in % | Logistic regression | ||
|---|---|---|---|---|---|---|
| Daridorexant 50 mg (active) | Placebo (comparator) | Odds ratio | 95% CI | |||
| Baseline | 1st night | 59/61 (96.72) | 58/60 (96.67) | 0.05 | ||
| 2nd night | 58/61 (95.08) | 58/60 (96.67) | − 1.58 | |||
| Day 1/2 | 1st night | 35/60 (58.33) | 51/60 (85.00) | − 26.67 | 4.11** | [1.70–9.92] |
| 2nd night | 36/61 (59.02) | 44/59 (74.58) | − 15.56 | 2.02 | [0.92–4.42] | |
| Day 28/29 | 1st night | 37/57 (64.91) | 44/57 (77.19) | − 12.28 | 1.86 | [0.81–4.26] |
| 2nd night | 34/57 (59.65) | 47/57 (82.46) | − 22.81 | 3.16** | [1.32–7.52] | |
| Visit | Visit | Patients n/N (%) | Patients n/N (%) | Difference in % | Logistic regression | |
|---|---|---|---|---|---|---|
| Zolpidem 10 mg (active) | Placebo (comparator) | Odds ratio | 95% CI | |||
| Baseline | 1st night | 58/60 (96.67) | 58/60 (96.67) | 0.00 | ||
| 2nd night | 56/60 (93.33) | 58/60 (96.67) | − 3.33 | |||
| Day 1/2 | 1st night | 46/60 (76.67) | 51/60 (85.00) | − 8.33 | 1.73 | [0.68–4.41] |
| 2nd night | 52/60 (86.67) | 44/59 (74.58) | 12.09 | 0.42 | [0.16–1.10] | |
| Day 28/29 | 1st night | 47/59 (79.66) | 44/57 (77.19) | 2.47 | 0.86 | [0.36–2.10] |
| 2nd night | 49/59 (83.05) | 47/57 (82.46) | 0.59 | 0.92 | [0.35–2.42] | |
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 < 0.05 for active vs comparator group. **p < 0.01 for active vs comparator group. ***p < 0.001 for active vs comparator group