Table 1.

Baseline Demographic and Sleep Characteristics (Safety Sample)

	Placebo (N=86)	Indiplon 10 mg (N=84)	Indiplon 20 mg (N=90)	P-value*
Female	74%	70%	70%	0.8434
Age, yr; mean ± sd	46.7 ± 9.5	45.2 ± 12.3	45.4 ± 11.0	0.7198
Race, %
White	73%	67%	80%
Black	19%	20%	16%
Other	8%	13%	4%	0.1331
Body mass index, mean ± sd	28.6 ± 6.9	27.7 ± 6.2	27.4 ± 6.7	0.9550
Sleep Characteristics After Post-Bedtime Dosing During Placebo Lead-in
LSOpd, min
Mean ± sd	72.4 ± 36.8	72.2 ± 29.2	80.2 ± 48.2
LSOPD ≥60 min in ≥50% of nights, %†	58.1%	54.8%	61.1%	0.2497
sWASOpd, min
Mean ± sd	27.7 ± 37.4	31.8 ± 28.8	37.4 ± 55.6
sWASOPD ≥30 min in ≥50% of nights, %†	20.9%	28.6%	17.8%	0.2809
sNAASOpd
Mean ± sd	1.2 ± 1.3	1.4 ± 1.2	1.5 ± 1.5
sNAASOPD ≥2-times in ≥50% of nights, %†	16.3%	20.2%	20.0%	0.3890
sTSTpd, min
Mean ± sd	203.9 ± 8.5	202.2 ± 8.5	198.4 ± 8.4	0.8542
Sleep Quality,
Mean ± sd	4.2 ± 1.1	4.3 ± 1.2	4.3 ± 1.1
Fair-to-extremely-poor, %	73.3.%	72.6%	80.0%	0.6221

^*P-values for gender and race were obtained from a generalized CMH procedure with study site as a stratification variable, comparing across treatment groups. P-values for the sleep parameters were obtained from an ANOVA model using log-transformed (base 10) data with main effects for treatment and study site, comparing across treatment groups. Sleep parameters were measured from when study drug was taken at the time of nighttime awakening

^†Proportion of patients reporting awakenings in ≥50% of the 2-week single-blind, placebo-controlled run-in period