Table 2a.
Effects of eszopiclone on sleep parameters in normal subjects with transient insomnia, and non-elderly and elderly patients with chronic primary insomnia
| Rosenberg et al (2005) | Zammit et al (2004) | |
|---|---|---|
| Study design | randomized double-blind placebo-controlled multicenter | randomized double-blind placebo-controlled multicenter |
| Number of patients | 436 healthy adults | 308 (95% completed the study) |
| Mean age (years) | 33.7 (range: 25–50) | 39.8 (range: 21–64) |
| Diagnostic criteria | transient insomia (first night effect) | DSM-IV criteria for primary insomnia |
| Number of drug evaluation night(s) | one night | 44 nights |
| Dosage (mg) | placebo (n = 98);eszopiclone 1 mg (n = 47); 2 mg (n = 97); 3 mg (n = 98); 3.5 mg (n = 96) | placebo (n = 99); eszopiclone 2 mg (n = 104); 3 mg (n = 105) |
| Assessment of sleep | polysomnography self-reports | polysomnography: nights 1, 15 and 29 self-reports: nights 1, 15 29 and 43/44 |
| Objective sleep parameters | ||
| Sleep induction | ||
| NREM sleep latency (min) | decrease (2–3.5 mg)a | decrease (2–3 mg)a,d |
| Sleep maintenance | ||
| Number of awakenings | decrease (3–3.5 mg)a | n.s.b,d |
| WASOe (min) | decrease (1–3.5 mg)a | decrease (3 mg)a,d |
| Total sleep time (min) | --- | --- |
| Sleep efficiency (%) | increase (1–3.5 mg)a | increase (2–3 mg)a,d |
| Sleep architecture | ||
| Stage 1 sleep (min or %) | decrease (3.5 mg)a | n.s.b,d |
| Stage 2 sleep (min or %) | increase (3.5 mg)a | increase (2–3 mg)a,d |
| Slow wave sleep (stage 3/4) (min or %) | n.s.b | n.s.b,d |
| REM latency (min) | --- | --- |
| REM sleep (min) | --- | n.s.b,d |
| REM sleep (% of TST)c | decrease (3.5 mg)a | --- |
| Subjective sleep parameters | ||
| Sleep latency | decrease (1–3.5 mg)a | decrease (2–3 mg)a,d |
| Number of awakenings | decrease (1–3.5 mg)a | --- |
| WASO | decrease (3–3.5 mg)a | decrease (3 mg)a,d |
| Total sleep time | increase (2–3.5 mg)a | increase (2–3 mg)a,d |
| Quality of sleep | increase (2–3.5 mg)a | increase (2–3 mg)a,d |
| Rebound insomnia | --- | present on the first night after discontinuation of treatment with2 mg eszopiclone |
| Tolerance | --- | absent |
a
Significantly different from placebo (p < 0.05)
b
n.s. = non-significant
c
TST = total sleep time
d
Average of nights 1, 15 and 29
e
WASO = wake time after sleep onset