ORIGINAL ARTICLEArmodafinil for Treatment of Excessive Sleepiness Associated With Shift Work Disorder: A Randomized Controlled Study
Section snippets
PATIENTS AND METHODS
This 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study was conducted with a common protocol at 42 centers in the United States (37) and Canada (5) from April 2 through December 23, 2004 (a center in Australia planned to but did not enroll any patients), in compliance with the International Conference on Harmonization's Good Clinical Practice Consolidated Guidance. An independent ethics committee or institutional review board at each center approved the
RESULTS
Of the 747 adults screened, 254 met entry criteria. Of these, 245 (96%) received at least 1 dose of study medication and were included in the safety analysis (Figure 1). At baseline, the armodafinil and placebo groups were similar in demographic variables and illness severity ratings (Table 1). Overall, 138 (56%) of 245 patients were rated by the investigator as moderately ill, and 107 (44%) of 245 patients were rated as markedly, severely, or extremely ill. Most patients (212/245; 87%) were
DISCUSSION
Treatment with armodafinil, 150 mg, significantly reduced sleep propensity and subjective ratings of sleepiness and improved aspects of attention and memory in patients with SWD during usual night shift hours. These differences were associated with significantly greater improvement in the severity of patients' overall clinical condition compared with those who received placebo. Armodafinil increased nighttime mean sleep latency to greater than 5 minutes, although a proportion of individuals
CONCLUSION
Armodafinil, 150 mg, significantly improved measures of sleep propensity, subjective sleepiness, memory, and attention during scheduled night work hours in patients with excessive sleepiness associated with SWD without disturbing daytime sleep. The effects on wakefulness were apparent during the night shift and the commute home. Concurrent improvements in overall clinical condition were also found. Armodafinil was generally well tolerated. These findings support the inclusion of armodafinil as
Acknowledgments
We gratefully acknowledge Gwendolyn E. Niebler, DO, former Cephalon employee, for her contribution to the protocol design, role as medical monitor, and contribution to drafts of the manuscript; Rod J Hughes, PhD, former Cephalon employee, for contribution to the protocol design and drafts of the manuscript; Ronghua āTigerā Yang, PhD, Cephalon employee, for statistical support during the submission and peer-review process; Mark Riotto, Cephalon employee, for editorial support; and Oxford
REFERENCES (52)
- et al.
Prevalence and consequences of sleep disorders in a shift worker population
J Psychosom Res
(2002) - et al.
Increased injuries on night shift
Lancet
(1994) - et al.
Evaluating sleepiness
- et al.
Vigilance and automobile accidents in patients with sleep apnea or narcolepsy
Chest
(1995) - et al.
Self-reported use of CPAP and benefits of CPAP therapy: a patient survey
Chest
(1996) - et al.
Accidents in obstructive sleep apnea patients treated with nasal continuous positive airway pressure: a prospective study
Chest
(1997) - et al.
Effects of armodafinil in the treatment of residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome: a 12-week, multicenter, double-blind, randomized, placebo-controlled study in nCPAP-adherent adults
Clin Ther
(2006) Workers on Flexible and Shift Schedules in 2004 Summary
Shift work and disturbed sleep/wakefulness
Occup Med (Lond)
(2003)- et al.
Circadian rhythm sleep disorders: pathophysiology and treatment
J Clin Neurophysiol
(1996)
Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers
Sleep
Sleep on the night shift: 24-hour EEG monitoring of spontaneous sleep/wake behavior
Psychophysiology
Shift work and sleep disorders [editorial]
Sleep
The International Classification of Sleep Disorders: Diagnostic and Coding Manual
Diagnostic and Statistical Manual of Mental Disorders: DSM-IV-TR
Rotating shift work, sleep, and accidents related to sleepiness in hospital nurses
Am J Public Health
The sleep of long-haul truck drivers
N Engl J Med
Health disorders of shift workers
Occup Med (Lond)
Peptic ulcer is prevalent among shift workers
Dig Dis Sci
Work hours, sleepiness and accidents: introduction and summary
J Sleep Res
Modafinil for excessive sleepiness associated with shift-work sleep disorder
N Engl J Med
Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss
Curr Med Res Opin
ECDEU Assessment Manual for Psychopharmacology. Revised, 1976
Guidelines for the multiple sleep latency test (MSLT): a standard measure of sleepiness
Sleep
Relations between performance and subjective ratings of sleepiness during a night awake
Sleep
Cited by (124)
Stimulant Drugs and Stimulant Use Disorder
2024, Anesthesiology ClinicsA brief history of circadian rhythm sleep disorders
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second EditionOverview and description of circadian rhythm sleep disorders
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second EditionThe role of pharmacological interventions for sleep deprivation and restriction
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second EditionSleepiness and fatigue in circadian rhythm sleep disorders
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second EditionAdjunctive and alternative treatments of circadian rhythm sleep disorders
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second Edition
Cephalon Inc funded the study and developed the protocol in collaboration with the authors. For more information on the role of the funding source, see page 971, and for the financial disclosures of the authors, see page 969.
This article is freely available on publication, because the authors have chosen the immediate access option, which is funded by Cephalon.
- ā
Died March 1, 2007; was an employee of Cephalon Inc.