. 2007 Aug;3(4):441–453.

Table 2b.

Effects of eszopiclone on sleep parameters in normal subjects with transient insomnia, and non-elderly and elderly subjects with chronic primary insomnia

	Krystal et al (2003)	Scharf et al (2005)	McCall et al (2006)
Study design	randomized double-blind placebo-controlled	randomized double-blind placebo-controlled	randomized double-blind placebo-controlled
Number of patients	788 (471 completed the study)	231 (210 completed the study)	264 (255 completed the study)
Mean age (years)	43.8 (range 21–69)	72.3 (range 64–85)	71.1
Diagnostic criteria	DSM-IV criteria for primary insomnia	DSM-IV criteria for primary insomnia	DSM-IV criteria for primary insomnia
Number of drug evaluation nights	6 months	2 weeks	2 weeks
Dosage (mg)	placebo (n = 196); eszopiclone 3 mg (n = 595)	placebo (n = 80); eszopiclone 1 mg (n = 72); 2 mg (n = 79)	placebo (n = 128); eszopiclone 2 mg (n = 136)
Assessment of sleep	interactive voice response system	interactive voice response system	polysomnography: nights 1, 2, 13 and 14; patients reports: nights 1 to 14
Objective sleep parameters
Sleep induction
NREM sleep latency (min)	---	---	decrease^a
Sleep maintenance
Number of awakenings	---	---	n.s.
WASO (min)	---	---	decrease^a
Total sleep time (min)	---	---	increase^a
Sleep efficiency (%)	---	---	increase^a
Sleep architecture
Stage 1 sleep (min or %)	---	---	n.s.
Stage 2 sleep (min or %)	---	---	increase^a
Slow wave sleep (stage 3/4) (min or %)	---	---	n.s.
REM latency (min)	---	---	---
REM sleep (min)	---	---	n.s.
REM sleep (% of TST)	---	---	increase^a
Subjective sleep parameters
Sleep latency	decrease^a	decrease (1–2 mg)^a	decrease^a
Number of awakenings	decrease^a	n.s.	decrease^a
WASO	decrease^a	decrease (2 mg)^a	decrease^a
Total sleep time	increase^a	increase (2 mg)^a	increase^a
Quality of sleep	increase^a	increase (2 mg)^a	increase^a
Rebound insomnia	---	---	---
Tolerance	absent	---	---

Significantly different from placebo (p < 0.05)