The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy

References

• Naumann A, Daum I. Narcolepsy: pathophysiology and neuropsychological changes. Behav Neurol 2003;14:89–98
   PubMed Web of Science ®Google Scholar
• Rieger M, Mayer G, Gauggel S. Attention deficits in patients with narcolepsy. Sleep 2003;26:36–43
   Google Scholar
• American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed. Diagnostic and coding manual. Westchester (IL): American Academy of Sleep Medicine; 2005
   Google Scholar
• Hublin C, Partinen M, Kaprio J, Koskenvuo M, Guilleminault C. Epidemiology of narcolepsy. Sleep 1994;17:S7–S12
   Google Scholar
• Dauvilliers Y, Baumann CR, Carlander B, et al. CSF hypocretin-1 levels in narcolepsy, Kleine-Levin syndrome, and other hypersomnias and neurological conditions. J Neurol Neurosurg Psychiatry 2003;74:1667–73
   PubMed Web of Science ®Google Scholar
• Mignot E. Genetic and familial aspects of narcolepsy. Neurology 1998;50:S16–S22
   PubMedGoogle Scholar
• Mignot E. Pathophysiology of narcolepsy. In: Kryger M, Roth T, Dement W, editors. Principles and practice of sleep medicine, 3rd ed. Philadelphia: Saunders; 2000. p. 663–75
   Google Scholar
• Mignot E, Hayduk R, Black J, Grumet FC, Guilleminault C. HLA DQB1*0602 is associated with cataplexy in 509 narcoleptic patients. Sleep 1997;20: 1012–20
   Google Scholar
• US Modafinil in Narcolepsy Multicenter Study Group. Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. Ann Neurol 1998;43:88–97
   PubMed Web of Science ®Google Scholar
• US Modafinil in Narcolepsy Multicenter Study Group. Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy. Neurology 2000;54:1166–75
   PubMed Web of Science ®Google Scholar
• Broughton RJ, Fleming JA, George CF, et al. Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy. Neurology 1997;49:444–51
   PubMed Web of Science ®Google Scholar
• Mitler MM, Harsh J, Hirshkowitz M, Guilleminault C. Long-term efficacy and safety of modafinil (PROVIGIL®) for the treatment of excessive daytime sleepiness associated with narcolepsy. Sleep Med 2000;1:231–43
   PubMed Web of Science ®Google Scholar
• Moldofsky H, Broughton RJ, Hill JD. A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy. Sleep Med 2000;1:109–16
   Google Scholar
• Schwartz JR, Feldman NT, Bogan RK, Nelson MT, Hughes RJ. Dosing regimen effects of modafinil for improving daytime wakefulness in patients with narcolepsy. Clin Neuropharmacol 2003;26:252–7
   Google Scholar
• Schwartz JR, Nelson MT, Schwartz ER, Hughes RJ. Effects of modafinil on wakefulness and executive function in patients with narcolepsy experiencing late-day sleepiness. Clin Neuropharmacol 2004;27:74–9
   PubMed Web of Science ®Google Scholar
• Robertson Jr P, Hellriegel ET. Clinical pharmacokinetic profile of modafinil. Clin Pharmacokinet 2003;42:123–37
   PubMed Web of Science ®Google Scholar
• Wong YN, King SP, Simcoe D, et al. Open-label, single-dose pharmacokinetic study of modafinil tablets: influence of age and gender in normal subjects. J Clin Pharmacol 1999;39:281–8
   PubMed Web of Science ®Google Scholar
• Wong YN, Simcoe D, Hartman LN, et al. A double-blind, placebo-controlled, ascending-dose evaluation of the pharmacokinetics and tolerability of modafinil tablets in healthy male volunteers. J Clin Pharmacol 1999;39:30–40
   PubMed Web of Science ®Google Scholar
• Dinges DF, Arora S, Darwish M, Niebler GE. Pharmaco-dynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss. Curr Med Res Opin 2006;22:159–67
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services. Guidance for industry. E6 good clinical practice: consolidated guidance. Rockville (MD): Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; 1996
   Google Scholar
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th ed. Washington (DC): American Psychiatric Association; 1994
   Google Scholar
• Thorpy MJ. The clinical use of the Multiple Sleep Latency Test. The Standards of Practice Committee of the American Sleep Disorders Association. Sleep 1992;15:268–76
   Google Scholar
• Guy W, ed. Clinical global impressions. In: ECDEU assessment manual for psychopharmacology. Rockville (MD): US Dept of Health and Human Services, National Institute of Mental Health; 1976. p. 218–22
   Google Scholar
• Mitler MM, Gujavarty KS, Browman CP. Maintenance of Wakefulness Test: a polysomnographic technique for evaluation treatment efficacy in patients with excessive somnolence. Electroencephalogr Clin Neurophysiol 1982;53:658–61
   Google Scholar
• Doghramji K, Mitler MM, Sangal RB, et al. A normative study of the Maintenance of Wakefulness Test (MWT). Electro-encephalogr Clin Neurophysiol 1997;103:554–62
   PubMedGoogle Scholar
• Simpson P, Wesnes K, Christmas L. A computerised system for the assessment of drug-induced performance changes in young, elderly or demented populations. Br J Clin Pharmacol 1989;27:711P–712P
   Google Scholar
• Wesnes K, Simmons D, Rook M, Simpson P. A double-blind placebo controlled trial of tanakan in the treatment of idiopathic cognitive impairment in the elderly. Hum Psychopharmacol 1987;2:159–69
   Google Scholar
• Wesnes KA, Ward T, McGinty A, Petrini O. The memory enhancing effects of a Ginkgo biloba/Panax ginseng combination in healthy middle-aged volunteers. Psychopharmacology (Berl) 2000;152:353–61
   PubMed Web of Science ®Google Scholar
• Wesnes KA, McKeith IG, Ferrara R, et al. Effects of rivastigmine on cognitive function in dementia with Lewy bodies: a randomised placebo-controlled international study using the cognitive drug research computerised assessment system. Dement Geriatr Cogn Disord 2002;13:183–92
   PubMed Web of Science ®Google Scholar
• Wesnes KA, McKeith I, Edgar C, Emre M, Lane R. Benefits of rivastigmine on attention in dementia associated with Parkinson disease. Neurology 2005;65:1654–6
   Google Scholar
• Wesnes K, Pincock C. Practice effects on cognitive tasks: a major problem? Lancet Neurol 2002;1:473
   PubMed Web of Science ®Google Scholar
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991;14:540–5
   PubMed Web of Science ®Google Scholar
• Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer 1999;85:1186–96
   PubMed Web of Science ®Google Scholar