Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT03545191 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) From baseline to Month 1 (i.e. for up to 1 month) | Daridorexant 25 mg | -28.17 minutes |
| Daridorexant 50 mg | -31.20 minutes | |||
| Placebo | -19.85 minutes | |||
| NCT03545191 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) From baseline to Month 1 (i.e. for up to 1 month) | Daridorexant 25 mg | -18.40 minutes |
| Daridorexant 50 mg | -28.98 minutes | |||
| Placebo | -6.20 minutes | |||
| NCT03545191 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) From baseline to Month 3 (i.e. for up to 3 months) | Daridorexant 25 mg | -30.73 minutes |
| Daridorexant 50 mg | -34.80 minutes | |||
| Placebo | -23.13 minutes | |||
| NCT03545191 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) From baseline to Month 3 (i.e. for up to 3 months) | Daridorexant 25 mg | -22.97 minutes |
| Daridorexant 50 mg | -29.41 minutes | |||
| Placebo | -11.11 minutes | |||
| NCT03575104 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) From baseline to Month 1 (i.e. for up to 1 month) | Daridorexant 10 mg | -22.62 minutes |
| Daridorexant 25 mg | -26.46 minutes | |||
| Placebo | -20.01 minutes | |||
| NCT03575104 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) From baseline to Month 1 (i.e. for up to 1 month) | Daridorexant 10 mg | -15.31 minutes |
| Daridorexant 25 mg | -24.19 minutes | |||
| Placebo | -12.57 minutes | |||
| NCT03575104 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) From baseline to Month 3 (i.e. for up to 3 months) | Daridorexant 10 mg | -23.09 minutes |
| Daridorexant 25 mg | -28.91 minutes | |||
| Placebo | -19.89 minutes | |||
| NCT03575104 | Sleep Initiation and Maintenance Disorders | Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) From baseline to Month 3 (i.e. for up to 3 months) | Daridorexant 10 mg | -15.95 minutes |
| Daridorexant 25 mg | -24.25 minutes | |||
| Placebo | -14.00 minutes | |||
| NCT03679884 | Sleep Initiation and Maintenance Disorders | Total no. of Subjects With at Least One TEAE TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks. | Daridorexant 10 mg | 53 Participants |
| Daridorexant 25 mg | 103 Participants | |||
| Daridorexant 50 mg | 55 Participants | |||
| ExPlacebo / Daridorexant 25 mg | 48 Participants | |||
| Placebo | 45 Participants |