The effects of armodafinil on objective sleepiness and performance in a shift work disorder sample unselected for objective sleepiness.
BACKGROUND
Armodafinil is a medication used to treat excessive sleepiness in individuals with shift work disorder (SWD). In the present study, we investigate whether armodafinil can normalize nocturnal sleepiness in a group of typical SWD patients.


METHODS
Participants were 12 night workers (aged 33.8 ± 8.57 years, 7 female subjects) with excessive sleepiness (≥10 on the Epworth Sleepiness Scale; mean, 14.8 ± 3.16), meeting the International Classification of Sleep Disorders, Second Edition criteria for SWD, with no other sleep or medical disorders verified by polysomnogram. The multiple sleep latency test (MSLT) was not used as an entry criteria. Armodafinil was administered at 10:30 pm in a randomized, double-blind, placebo-controlled, crossover design with experimental nights separated by 1 week. Primary end point was the MSLT, with naps at 1:30, 3:30, 5:30, and 7:30 am. Other study measures included a sleepiness-alertness visual analog scale administered before each nap, and 2 computer-based performance tests evaluating attention and memory.


RESULTS
Subjects with SWD had a mean MSLT of 5.3 ± 3.25 minutes, indicating a mean level of pathological sleepiness. Armodafinil significantly improved MSLT score to 11.1 ± 4.79 minutes (P = 0.006). Subjective levels of alertness on the visual analog scale also improved (P = 0.008). For performance, reaction time to central (P = 0.006) and peripheral (P = 0.003) stimuli and free recall memory (P = 0.05) were also improved.


CONCLUSIONS
Armodafinil 150 mg administered at the beginning of a night shift normalizes nocturnal sleepiness in individuals with SWD unselected for objective sleepiness. Subjective measures of sleepiness and cognitive performance are also improved. This suggests that armodafinil can improve levels of nocturnal alertness to within normal daytime levels in the majority of patients with SWD.
From the Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI.
Ryan
R
Howard
Thomas
T
Roth
Christopher L
CL
Drake
D000328:Adult; D001288:Attention / Q000187:drug effects; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D018592:Cross-Over Studies; D003936:Diagnosis, Computer-Assisted; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008568:Memory / Q000187:drug effects; D000077408:Modafinil; D011597:Psychomotor Performance / Q000187:drug effects; D011930:Reaction Time / Q000187:drug effects; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects*; D064690:Wakefulness-Promoting Agents / Q000627:therapeutic use*; D014940:Work Schedule Tolerance
D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil