Double-blind randomized controlled study of the efficacy, safety and tolerability of eszopiclone vs placebo for the treatment of patients with post-traumatic stress disorder and insomnia

Table 1 Baseline demographic and clinical characteristics of patient (n = 25)

Characteristics	Eszopiclone	Placebo	Total sample
	(n = 13)	(n = 12)	(n = 25)
Age, mean ± SD	38 ± 11.6	48 ± 11.3	43 ± 12.2
Sex, male, n (%)	8 (54)	7 (58)	15 (60)
Race, n (%)
White	4	2	6 (24)
African American	7	7	14 (56)
Hispanic	1	1	2 (8
Mixed	1	2	3 (12)
Education status, college graduate, n (%)	5	4	9 (36)
Duration of illness in years, mean ± SD	5 ± 7	7 ± 8	6 ± 8
Current comorbidity, n (%)
Major depressive disorder	7	7	14
Social anxiety disorder	2	1	3
Generalized anxiety disorder	0	1	1
Lifetime depression, n	8	9	17
Lifetime alcohol or substance abuse or dependency, n	8	3	11
Concomitant antidepressant, n	0	2	2
Concomitant benzodiazepine, n	0	1	1
Drop-outs	6	3	9

Table 2 Outcome measures – completers

	Eszopiclone		Placebo
Measure	Baseline (mean ± SD)	Endpoint (mean ± SD)	Baseline (mean ± SD)	Endpoint (mean ± SD)	t (df)	P value
CAPS total score	65 ± 22.04	40 ± 20.13	64 ± 10.93	41 ± 16.94	-0.13 (22)	0.70
SPRINT total score	22 ± 5.55	13 ± 6.58	24 ± 3.61	14 ± 4.79	-0.58 (22)	0.56
PSQI total score	12.58 ± 3.12	8.38 ± 3.35	12.33 ± 3.94	7.44 ± 2.31	0.24 (22)	0.81
Total sleep time	6.75 ± 2.11	7.00 ± 1.82	6.15 ± 1.74	6.78 ± 1.26	0.13 (10)	0.41
Sleep latency	31.11 ± 26.54	39.70 ± 48.16	44.06 ± 37.55	37.42 ± 26.27	0.68 (10)	0.77
MADRAS total score	24.25 ± 7.28	18.33 ± 9.59	25.56 ± 9.46	21.00 ± 10.80	0.73 (22)	0.47
CGI severity	4.42 ± 0.79	4.00 ± 0.95	4.50 ± 0.80	4.08 ± 0.79	0.00 (22)	1.00
LIFE-RIFT total score	13.50 ± 2.64	11.92 ± 4.14	13.58 ± 2.87	12.83 ± 3.22	0.92 (22)	0.37

CAPS: Clinician-Administered Post-Traumatic Stress Disorder Scale; SPRINT: Short Post-Traumatic Stress Disorder Rating Interview; PSQI: Pittsburgh Sleep Quality Index with Post-Traumatic Stress Disorder Addendum; CGI: Clinical Global Impression; LIFE-RIFT: Range of Impaired Functioning Tool.