Table 2.
Demographic characteristics of subjects in the clinical studies (full analysis population)
| Interventional study in subjects with insomniaa | Observational study in good sleepers (N = 103) | ||
|---|---|---|---|
| Full sample (N = 114) |
Exit interviews (N = 41) |
||
| Age, years | |||
| Mean (SD) | 51 (12) | 57 (10) | 45 (17) |
| Median (range) | 53 (19–74) | 57 (33–74) | 44 (18–74) |
| Sex, n (%) | |||
| Female | 74 (65) | 24 (59) | 62 (60) |
| Race, n (%) | |||
| Black or African American | 23 (20) | 13 (32) | 25 (24) |
| Asian | 0 | 0 | 2 (2) |
| White/Caucasian | 91 (80) | 28 (68) | 70 (68) |
| Other | 0 | 0 | 4 (4) |
| Unknown | 0 | 0 | 2 (2) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 10 (9) | 5 (12) | 10 (10) |
| Not Hispanic or Latino | 104 (91) | 36 (88) | 88 (85) |
| Not disclosed | 0 | 0 | 5 (5) |
| ISI total score at screening, n (%) | |||
| 0–7 (no clinically significant insomnia) | 0 | ||
| 8–14 (subthreshold insomnia) | 0 | ||
| 15–21 (moderate insomnia | 86 (75) | ||
| 22–28 (severe insomnia) | 28 (25) | ||
| Severity of daytime sleepiness at baseline based on PGA-S, n (%) | |||
| None/very mild/mild | 9 (8) | 77 (75) | |
| Moderate | 40 (35) | 22 (21) | |
| Severe | 61 (54) | 4 (4) | |
| Missing | 4 (4) | 0 | |
| Current sleep-related health, n (%)b | |||
| Excellent | 28 (27) | ||
| Very good | 47 (46) | ||
| Good | 25 (24) | ||
| Fair | 3 (3) | ||
DSM-IV Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, ISI Insomnia Severity Index, PGA-S Patient Global Assessment of Disease Severity, SD standard deviation
aAccording to DSM-5
bCurrent sleep-related health was assessed by asking participants to rate their current health on a 5-point scale, severity of sleepiness over the previous 3 months on a 6-point scale, and average sleepiness in the previous week on a 10-point scale