Table 1.
Summary of study characteristics of ultra-low-dose doxepin in randomized placebo-controlled trials in chronic primary insomnia
| Studies | Sample size | % completed (No. of dropouts) | Mean age, years (range) | Design | Placebo wash-in | Doxepin doses, mg | Duration, days | Outcomes |
|
|---|---|---|---|---|---|---|---|---|---|
| Self-report | PSG | ||||||||
| Adults (age <65 years) | |||||||||
| Roth et al. 200713 | 67 | 98.5 (1) | 42.4 (18-64) | Cross-over | Yes | 1, 3, 6 | * | Yes | Yes |
| Krystal et al. 201114 | 229 | 89 (26) | 44.5 (18-64) | Parallel | Yes | 3, 6 | 35 | Yes | Yes |
| Older adults (age ≥65 years) | |||||||||
| Scharf et al. 200810 | 76 | 96.1 (3) | 71 | Cross-over | Yes | 1, 3, 6 | * | Yes | Yes |
| Krystal et al. 20105 | 240 | 89 (26) | 71.4 (64-93) | Parallel | Yes | 1, 3 | 84 | Yes | Yes |
| Lankford et al. 20126 | 254 | 93 (18) | 72.5 (64-91) | Parallel | Yes | 6 | 28 | Yes | No |
PSG, polysomnogram.
*
Five 2-day treatment periods with a 5- or 12-day drug-free interval between treatment periods.