Table 1.
Clinical adverse experiences summary
| Double-blind treatment phase | Single-blind | |||
|---|---|---|---|---|
| Number (%) subjects | Gaboxadol 10 mg (n = 24) | Zolpidem 5 mg (n = 23) | Placebo (n = 23) | Gaboxadol 10 mg (n = 22) |
| Subjects with ≥1 adverse experiences | 14 (58.3) | 7 (30.4) | 9 (39.1) | 6 (27.3) |
| Most common adverse experiences* | ||||
| Dizziness | 5 (20.8) | 2 (8.7) | 1 (4.3) | 1 (4.5) |
| Fatigue | 3 (12.5) | 3 (13.0) | 3 (13.0) | 1 (4.5) |
| Headache | 2 (8.3) | 0 (0) | 1 (4.3) | 1 (4.5) |
| Insomnia | 1 (4.2) | 0 (0) | 2 (8.7) | 0 (0) |
| Nausea | 3 (12.5) | 1 (4.3) | 1 (4.3) | 0 (0) |
| Vomiting | 2 (8.3) | 0 (0) | 0 (0) | 0 (0) |
| Subjects with ≥1 drug-related adverse experience† | 12 (50.0) | 6 (26.1) | 5 (21.7) | 3 (13.6) |
| Most common drug-related adverse experiences*† | ||||
| Dizziness | 5 (20.8) | 2 (8.7) | 1 (4.3) | 0 (0.0) |
| Fatigue | 3 (12.5) | 3 (13.0) | 3 (13.0) | 1 (4.5) |
| Nausea | 3 (12.5) | 1 (4.3) | 1 (4.3) | 0 (0) |
| Vomiting | 2 (8.3) | 0 (0) | 0 (0) | 0 (0) |
*
≥5.0% incidence in any one treatment group.
†
Considered by the investigator to be possibly, probably, or definitely related to study drug. Although a subject may have had an adverse experience more than once or with changing intensity, the subject is counted only once for a specific adverse experience. The same subject may be counted in more than one row. After the first dosing of study drug, adverse experiences that began predose and did not change intensity post dose were counted with the treatment received in the previous period.