Table 3.
TEAEs by age group
| Age < 65 years | Age ≥ 65 years | |||||
|---|---|---|---|---|---|---|
| Daridorexant 50 mg n = 189 |
Daridorexant 25 mg n = 189 |
Placebo n = 187 |
Daridorexant 50 mg n = 119 |
Daridorexant 25 mg n = 121 |
Placebo n = 122 |
|
| Adverse events | ||||||
| Patients with ≥ 1 TEAE | 74 (39) | 78 (41) | 67 (36) | 42 (35) | 39 (32) | 38 (31) |
| Patients with ≥ 1 serious TEAE | 3 (2) | 1 (< 1) | 4 (2) | 0 | 1 (1) | 3 (3) |
| TEAEs leading to treatment discontinuation | 2 (1) | 6 (3) | 4 (2) | 1 (1) | 1 (1) | 6 (5) |
| Patients with TEAEa (≥ 2% in any group) | ||||||
| Nasopharyngitis | 13 (6.9) | 19 (10.1) | 16 (8.6) | 7 (5.9) | 2 (1.7) | 4 (3.3) |
| Headache | 13 (6.9) | 11 (5.8) | 7 (3.7) | 6 (5.0) | 5 (4.1) | 5 (4.1) |
| Nausea | 3 (1.6) | 1 (0.5) | 2 (1.1) | 4 (3.4) | 0 | 1 (0.8) |
| Fatigue | 4 (2.1) | 3 (1.6) | 1 (0.5) | 3 (2.5) | 4 (3.3) | 1 (0.8) |
| Accidental overdose | 5 (2.6) | 3 (1.6) | 5 (2.7) | 3 (2.5) | 1 (0.8) | 0 |
| Dizziness | 6 (3.2) | 2 (1.1) | 1 (0.5) | 1 (0.8) | 4 (3.3) | 1 (0.8) |
| Back pain | 5 (2.6) | 0 | 3 (1.6) | 1 (0.8) | 2 (1.7) | 1 (0.8) |
| Somnolence | 4 (2.1) | 5 (2.6) | 5 (2.7) | 1 (0.8) | 6 (5.0) | 1 (0.8) |
| Diarrhoea | 1 (0.5) | 6 (3.2) | 3 (1.6) | 1 (0.8) | 0 | 1 (0.8) |
| Fall | 0 | 0 | 4 (2.1) | 1 (0.8) | 1 (0.8) | 4 (3.3) |
| Influenza | 4 (2.1) | 3 (1.6) | 3 (1.6) | 0 | 0 | 2 (1.6) |
| Upper abdominal pain | 0 | 0 | 0 | 0 | 3 (2.5) | 1 (0.8) |
| Adjudicated adverse events | ||||||
| Excessive daytime sleepiness | 1 (< 1) | 1 (< 1) | 1 (< 1) | 0 | 1 (1) | 0 |
| Sleep paralysis | 0 | 1 (< 1) | 0 | 1 (1) | 0 | 0 |
| Hallucinations | 0 | 1 (< 1) | 0 | 0 | 0 | 0 |
Data are presented as n (%). TEAE data by preferred term are reproduced with permission from [35]
TEAE treatment-emergent adverse event
aTEAEs that occurred during the double-blind treatment period presented with their preferred term; TEAEs are sorted by descending frequency in the daridorexant 50-mg group in adults aged ≥ 65 years, followed by age < 65 years listed in order