Table 3.

Summary outcomes for patients receiving modafinil or placebo in the SWD studies

Study/Reference	Measure	Treatment	Mean (SD) at baseline	Mean (SD) at final visit	Mean (SD) change from baseline to final visit	P-valuea
12-week study #1/Czeisler et al 2005	MSLT sleep latency (min)	Modafinil 200 mg	2.07 (0.2)	3.77 (0.5)	1.7 (0.4)	0.002
		Placebo	2.04 (0.2)	2.37 (0.3)	0.3 (0.3)
	KSS score	Modafinil 200 mg	7.3 (0.1)	5.8 (0.2)	−1.5 (0.2)	<0.001
		Placebo	7.1 (0.1)	6.7 (0.2)	−0.4 (0.2)
	PVT number of lapses	Modafinil 200 mg	12.50b	10.25b	−2.6c	<0.001
		Placebo	16.13b	23.75b	3.8c
12-week study #2/Erman et al 2007	FOSQ total scored	Modafinil 300 mg			2.3	<0.05
		Placebo			1.6
	FOSQ vigilance	Modafinil 300 mg			0.6	<0.05
		Placebo			0.4
	FOSQ activity	Modafinil 200 mg			0.5	<0.05
		Placebo			0.3
		Modafinil 300 mg			0.5	<0.01
		Placebo			0.3
	FOSQ productivity	Modafinil 300 mg			0.4	<0.01
		Placebo			0.3
	SF-36 mental component scoree	Modafinil 200 mg			3.7	<0.05
		Modafinil 300 mg			3.2	<0.05
		Placebo			0.7
	SF-36 vitality	Modafinil 200 mg			15.0	<0.001
		Modafinil 300 mg			14.8	<0.0001
		Placebo			5.3
	SF-36 role emotional	Modafinil 300 mg			4.3	<0.05
		Placebo			−2.9

^aFor the change from baseline for modafinil versus placebo.

^bMedian number of lapses.

^cMedian change from baseline.

^dFOSQ total scores at baseline were similar for modafinil 200 mg, modafinil 300 mg, and placebo (range: 14.3–14.7 points).

^eSF-36 mental component scores at baseline were similar for the 3 groups (range: 45.3–47.4).

Abbreviations: SD, standard deviation; SWD, shift work disorder; MSLT, Multiple Sleep Latency Test; PVT, Psychomotor Vigilance Task; KSS, Karolinska Sleepiness Score; FOSQ, Functional Outcomes of Sleep Questionnaire; SF-36, 36-item Short Form Health Survey.