Modafinil for Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder: Effects on Patient Functioning and Health-Related Quality of Life
Prim Care Companion J Clin Psychiatry 2007;9(3):188-194
© Copyright 2015 Physicians Postgraduate Press, Inc.
Objective: We evaluated the effects
of modafinil, a wake-promoting agent, on patient functioning, health-related quality of life,
and nighttime and daytime sleep in patients with
excessive sleepiness associated with shift work sleep disorder (SWSD).
Method: A 12-week, randomized,
double-blind, placebo-controlled study was performed
at 31 centers in the United States between
February 2001 and March 2002. Adults (N = 278) with
excessive sleepiness associated with chronic SWSD (International Classification of Sleep
Disorders criteria) were randomly assigned to
receive modafinil 200 or 300 mg or placebo, 30 to
60 minutes before each night shift. Effects on
patient functioning and quality of life were assessed
using the Functional Outcomes of Sleep Questionnaire (FOSQ) and the 36-item Short Form
Health Survey (SF-36), respectively. Daily patient
diaries were used as a sleep log.
Results: Modafinil 300 mg significantly
improved mean FOSQ total score relative to placebo (2.3-point increase from baseline vs. 1.6 for
placebo; p < .05). Both doses of modafinil
significantly improved mean SF-36 mental component scores relative to placebo (mean changes
from baseline of 3.2, 3.7, and 0.7 points in the modafinil 300-mg, modafinil 200-mg, and
placebo groups, respectively; p < .05 for each
comparison vs. placebo). Modafinil did not
adversely affect sleep when sleep was desired or
caffeine use. Modafinil was well tolerated.
Headache (21.5%) and nausea (12.4%) were the most
common adverse events in modafinil-treated
patients. Differences between modafinil and placebo
for vital sign measurements, physical examination findings, or electrocardiography results were
not clinically meaningful.
Conclusions: Modafinil significantly
improves functioning and quality of life in
patients with SWSD. Modafinil is an effective
treatment for excessive sleepiness associated with SWSD.