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. 2009 Feb 6;2:71–85. doi: 10.2147/dddt.s2377

Table 2.

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

Study/Reference Measure Treatment Mean at baseline Mean at final visit Mean (SD) change from baseline to final visit P-valuea
4-week study/Pack et al 2001 MSLT sleep latency (min) Modafinil 400 mg 7.4 8.6 <0.05
Placebo 7.5 7.2
ESS score Modafinil 400 mg 14.2 9.6 <0.001
Placebo 14.4 12.4
4-week study/Dinges and Weaver 2003 PVT number of lapses (msec) Modafinil 400 mg −0.814 (0.426) 0.112
Placebo 0.346 (.550)
PVT number of lapses transformed (msec) Modafinil 400 mg −0.532 (0.177b) 0.01
Placebo 0.118 (0.171b)
PVT median reaction time (msec) Modafinil 400 mg −10.343 (4.424b) 0.01
Placebo 4.936 (4.777b)
12-week study/Black and Hirshkowitz 2005 MWT sleep latency (min) Modafinil 200 mg 1.6 <0.0001c
Modafinil 400 mg 1.5
Placebo −1.1
ESS score Modafinil 200 mg −4.5 <0.0001c
Modafinil 400 mg −4.5
Placebo −1.8
FOSQ total score Modafinil 200 mg 1.92 (2.47) 0.001d
Modafinil 400 mg 2.13 (2.61)
Placebo 0.84 (1.89)
FOSQ vigilance Modafinil 200 mg 0.48 (0.67) 0.0007d
Modafinil 400 mg 0.55 (0.59)
Placebo 0.25 (0.54)
FOSQ general productivity Modafinil 200 mg 0.30 (0.45) 0.0006d
Modafinil 400 mg 0.33 (0.49)
Placebo 0.08 (0.40)
FOSQ activity Modafinil 200 mg 0.41 (0.59) 0.02d
Modafinil 400 mg 0.45 (0.65)
Placebo 0.20 (0.49)
a

For the change from baseline for modafinil versus placebo.

b

SEM.

c

For overall and pairwise comparisons of modafinil with placebo.

d

For overall comparisons of modafinil with placebo.

Abbreviations: SD, standard deviation; OSA, obstructive sleep apnea; MSLT, Multiple Sleep Latency Test; ESS, Epworth Sleepiness Scale; PVT, Psychomotor Vigilance Task; MWT, Maintenance of Wakefulness Test; FOSQ, Functional Outcomes of Sleep Questionnaire.