Baseline demographics and clinical characteristics. Non-missing data reported.
| Characteristic | All Randomized Patients | Patients Who Completed the Study |
|---|---|---|
| No. patients | 195 | 151 |
| Mean age, yrs (SD) | 46.5 (11.3) | 46.9 (11.0) |
| Caucasian, % | 92 | 91 |
| Women, % | 94 | 94 |
| Mean body mass index (SD) | 30.2 (7.5) | 30.5 (7.6) |
| Duration of FM ≥ 5 yrs, % | 74 | 76 |
| Self-reported sleep | ||
| Sleep ≤ 6 h/night, % | 74 | 74 |
| Awakening ≥ 3 times/night, % | 66 | 68 |
| Sleep depth = light or very light, % | 78 | 81 |
| How refreshing is your sleep? | ||
| Mean (SD) | 77.0 (19.9) | 77.0 (19.6) |
| Median (range) | 82.0 (1.0–100.0) | 80.0 (1.0–100.0) |
| How sleepy do you usually feel in the morning? | ||
| Mean (SD) | 24.4 (22.1) | 25.0 (22.6) |
| Median (range) | 17.0 (0.0–100.0) | 19.0 (0.0–100.0) |
| How sleepy do you usually feel in the evening? | ||
| Mean (SD) | 31.9 (28.8) | 31.9 (29.5) |
| Median (range) | 21.0 (0.0–100.0) | 21.0 (1.0–100.0) |
| Mean PVAS, mm (SD) | 66.0 (16.5) | 66.4 (16.1) |
| Median PVAS, mm (range) | 66.7 (6.4–100.0) | 66.9 (6.4–100.0) |
| Daytime functioning, mean (SD) | (n = 191) | (n = 149) |
| Functional outcome of sleep (range 5–20)* | 12.0 (3.5) | 11.7 (3.5) |
| SF-36 Vitality domain (range 0–100)* | 28.7 (6.0) | 29.0 (6.0) |
| Fibromyalgia Impact Questionnaire | ||
| How tired have you been? (range 0–10)** | 8.0 (1.4) | 8.0 (1.4) |
| How have you felt when you get up in the morning? (range 0–10)** | 8.0 (1.5) | 8.0 (1.4) |
| Sleep and daytime sleepiness, mean (SD) | (n = 191) | (n = 149) |
| Jenkins Scale for Sleep (range 0–20)† | 16.6 (3.4) | 16.8 (3.2) |
| Epworth Sleepiness Scale (range 0–24)** | 11.2 (5.7) | 11.9 (5.6) |
| Fatigue VAS (range 0–100)**, mean (SD) | (n = 195) | (n = 151) |
| Overall | 69.7 (16.2) | 70.2 (15.7) |
| Morning | 67.9 (18.1) | 68.2 (17.6) |
| Afternoon | 68.3 (16.8) | 68.9 (16.5) |
| Evening | 72.8 (16.2) | 72.9 (15.7) |