Table 2.
Summary of Adverse Events during the Treatment Period (All Patients as Treated)
| Filorexant 10 mg (n = 64) | Placebo (n = 64) | |
|---|---|---|
| Number (%) of patients | ||
| With ≥1 AE | 27 (42.2) | 17 (26.6) |
| With drug-related AEs | 16 (25.0) | 6 (9.4) |
| With SAEs | 1 (1.6) | 0 (0) |
| With drug-related SAEs | 0 (0) | 0 (0) |
| Discontinued due to AEs | 1 (1.6) | 1 (1.6) |
| Discontinued due to drug- related AE | 1 (1.6) | 0 (0) |
| Discontinued due to a SAE | 0 (0) | 0 (0) |
| Common AEs (incidence ≥4 patients in either treatment group) | ||
| Somnolence | 5 (7.8) | 0 (0) |
| Suicidal ideationa | 5 (7.8) | 1 (1.6) |
| Dizziness | 0 (0) | 4 (6.3) |
| Headache | 4 (6.3) | 5 (7.8) |
Abbreviations: AE, adverse event; SAE, serious adverse event.
aA total of 10 patients reported suicidal ideation during the treatment period based on AE/ECI reports and/or positive responses to the C-SSRS: filorexant =7/64 (10.9%), placebo, 3/64 (4.7%). See main text for further details.