Table 3.
Effect of doxepin and placebo on subjective sleep and global outcomes parameters
| Measure | Baseline |
Week 1 |
Week 4 |
Week 12 |
||||
|---|---|---|---|---|---|---|---|---|
| Mean | (SD) | Mean | (SD) | Mean | (SD) | Mean | (SD) | |
| LSO (min)1 | ||||||||
| Placebo | 56.3 | (32.4) | 59.7 | (47.2) | 56.5 | (36.8) | 55.5 | (39.5) |
| DXP 1 mg | 60.8 | (51.2) | 54.2 | (34.6) | 45.2* | (30.0) | 37.5** | (22.8) |
| DXP 3 mg | 48.0 | (25.7) | 40.0** | (28.2) | 48.6* | (48.7) | 39.9* | (30.3) |
| sTST (min)1 | ||||||||
| Placebo | 280.2 | (87.9) | 316.2 | (68.3) | 317.5 | (83.2) | 326.0 | (77.9) |
| DXP 1 mg | 297.6 | (73.3) | 319.7 | (84.6) | 348.8* | (60.3) | 371.5** | (59.8) |
| DXP 3 mg | 308.7 | (80.9) | 356.8** | (61.1) | 362.5** | (65.4) | 389.4*** | (65.9) |
| Sleep Quality1 | ||||||||
| Placebo | −0.1 | (1.0) | 0.0 | (1.2) | 0.1 | (1.2) | 0.2 | (1.0) |
| DXP 1 mg | 0.0 | (0.8) | 0.2 | (1.1) | 0.5* | (1.0) | 0.8* | (0.9) |
| DXP 3 mg | 0.1 | (0.8) | 0.6** | (0.9) | 0.7** | (0.9) | 0.9** | (0.9) |
| CGI-Improvement2 | ||||||||
| Placebo | 3.6 | (0.8) | 3.2 | (1.0) | 3.2 | (1.1) | 3.1 | (1.1) |
| DXP 1 mg | 3.7 | (0.7) | 3.2 | (0.9) | 3.0 | (1.0) | 2.6** | (1.2) |
| DXP 3 mg | 3.7 | (0.9) | 2.7** | (1.1) | 2.8* | (1.2) | 2.4*** | (1.1) |
| Insomnia Severity Index2 | ||||||||
| Placebo | 15.4 | (3.8) | 14.0 | (4.2) | 13.5 | (4.0) | 13.0 | (4.9) |
| DXP 1 mg | 14.3 | (4.4) | 12.9 | (4.4) | 12.0 | (4.3) | 10.9 | (4.9) |
| DXP 3 mg | 15.1 | (3.8) | 12.5* | (4.6) | 11.6** | (4.9) | 10.6** | (4.7) |
SD, standard deviation; DXP, doxepin; LSO, latency to sleep onset; sTST, subjective total sleep time; sleep quality scale from −3 to 3; −3 = extremely poor to 3 = excellent;
1
these data were obtained from the IVRS analysis set;
2
assessments occurred after Weeks 2, 4, and 12;
*
P < 0.05 vs placebo;
**
P < 0.01;
***
P < 0.001