Armodafinil in the treatment of excessive Sleepiness

Nature and Science of Sleep

Volumn 2, Issue , 2010, Pages 95-105

  Rosenberg, Russell ^a   Bogan, Richard ^b  

^a Neuro Trials Research   (United States)

^b SleepMed of South Carolina   (United States)

Author keywords

Excessive sleepiness; Narcolepsy; Obstructive sleep apnea; Shift work disorder; Wakefulness promoting agent

Indexed keywords

EID: 80054765595     PISSN: None     EISSN: 11791608     Source Type: Journal    
DOI: 10.2147/nss.s6728     Document Type: Review

References (78)

1. Sack RL, Auckley D, Auger RR, et al. Circadian rhythm sleep disorders: part I, basic principles, shift work and jet lag disorders. An American Academy of Sleep Medicine review. Sleep. 2007;30(11): 1460-1483. (Pubitemid 350036973)
2. National Sleep Foundation. 2008 Sleep in America Poll. Washington, DC: National Sleep Foundation; 2008.
3. Thorpy MJ, Lieberman JA 3rd, Roth T, Owens GS. Patient identification. Am J Manag Care. 2007;13 Suppl 6:S132-S139. (Pubitemid 350231680)
4. National Heart, Lung, and Blood Institute Working Group on Insomnia. Insomnia: assessment and management in primary care. Am Fam Physician. 1999;59(11):3029-3038.
5. Neubauer DN. Current and new thinking in the management of comorbid insomnia. Am J Manag Care. 2009;15 Suppl:S24-S32.
6. Sateia MJ. Update on sleep and psychiatric disorders. Chest. 2009;135(5):1370-1379.
7. Parish JM. Sleep-related problems in common medical conditions. Chest. 2009;135(2):563-572.
8. Pilcher JJ, Ginter DR, Sadowsky B. Sleep quality versus sleep quantity: relationships between sleep and measures of health, well-being and sleepiness in college students. J Psychosom Res. 1997;42(6): 583-596. (Pubitemid 27299953)
9. Newman AB, Spiekerman CF, Enright P, et al. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. The Cardiovascular Health Study Research Group. J Am Geriatr Soc. 2000;48(2):115-123. (Pubitemid 30106514)
10. Elwood P, Hack M, Pickering J, Hughes J, Gallacher J. Sleep disturbance, stroke, and heart disease events: evidence from the Caerphilly cohort. J Epidemiol Community Health. 2006;60(1):69-73. (Pubitemid 43028633)
11. Bixler EO, Vigontzas AN, Lin HM, Calhoun SL, Vela-Bueno A, Kales A. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes, and depression. J Clin Endocrinol Metab. 2005;90(8):4510-4515. (Pubitemid 41159334)
12. Ferini-Strambi L, Baietto C, Di Giola MR, et al. Cognitive dysfunction in patients with obstructive sleep apnea (OSA): partial reversibility after positive airway pressure (CPAP). Brain Res Bull. 2003;61(1):87-92. (Pubitemid 36682986)
13. Dean B, Aguilar D, Shapiro C, et al. Impaired health status, daily functioning, and work productivity in adults with excessive sleepiness. J Occup Environ Med. 2010;52:144-149.
14. Omachi TA, Claman DM, Blanc PD, Eisner MD. Obstructive sleep apnea: a risk factor for work disability. Sleep. 2009;32(6):791-798.
15. Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004;27(8):1453-1462. (Pubitemid 40041612)
16. Leger D. The cost of sleep-related accidents: a report for the National Commission on Sleep Disorders Research. Sleep. 1994;17(1): 84-93. (Pubitemid 24103645)
17. Flatley D, Reyner LA, Horne JA. Sleep-related crashes on sections of different road types in the UK (1995-2001). London: Department of Transport, Road Safety Research; Report No. 52; 2004.
18. Pandi-Perumal SR, Verster JC, Kayumov L, et al. Sleep disorders, sleepiness and traffic safety: a public health menace. Braz J Med Biol Res. 2006;39(7):863-871. (Pubitemid 44111053)
19. US Department of Transportation. Effects of sleep schedules on commercial motor vehicle driver performance. 2000. Available from: http://www.fmcsa.dot. gov/documents/execsumm-e1.pdf. Accessed Dec 22, 2009.
20. Lopes C, Esteves AM, Bittencourt LRA, Tufik S, Mello MT. Relationship between the quality of life and the severity of obstructive sleep apnea syndrome. Braz J Med Biol Res. 2008;41(10):908-913.
21. Dodel R, Peter H, Noelker C, et al. Health-related quality of life in patients with narcolepsy. Sleep Med. 2007;8(7-8):733-741. (Pubitemid 47553545)
22. Ozaki A, Inoue Y, Nakajima T, et al. Health-related quality of life among drug-naïve patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time. J Clin Sleep Med. 2008;4(6):572-578.
23. Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Wasleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001;24:96-105. (Pubitemid 32096739)
24. Briones B, Adams N, Strauss M, et al. Relationship between sleepiness and general health status. Sleep. 1996;19:583-588. (Pubitemid 26339704)
25. Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003;7:335-349. (Pubitemid 36935312)
26. Sforza E, Janssens JP, Rochat T, Ibanez V. Determinants of quality of life in patients with sleep-related breathing disorders. Eur Respir J. 2003;21(4):682-687. (Pubitemid 36437482)
27. Chervin RD. Sleepiness, fatigue, tiredness, and lack of energy in obstructive sleep apnea. Chest. 2000;118(2):372-379. (Pubitemid 30637802)
28. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540-545.
29. Carskadon MA, Dement WC, Mitler MM, Roth T, Westbrook PR, Keenan S. Guidelines for the Multiple Sleep Latency Test (MSLT): a standard measure of sleepiness. Sleep. 1986;9:519-524. (Pubitemid 17131209)
30. Littner MR, Kushida C, Wise M, et al. Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. Sleep. 2005;28:113-121. (Pubitemid 40543126)
31. American Academy of Sleep Medicine. International Classification of Sleep Disorders. Diagnostic and Coding Manual. 2nd Ed. Westchester, IL: American Academy of Sleep Medicine; 2005.
32. Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993;328(17):1230-1235. (Pubitemid 23115702)
33. Smith IE, Quinnell TG. Pharmacotherapies for obstructive sleep apnoea: where are we now? Drugs. 2004;64(13):1385-1399. (Pubitemid 38980454)
34. Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981;1(8225):862-865. (Pubitemid 11099316)
35. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-719. (Pubitemid 46854758)
36. Morgenthaler TI, Kapen S, Lee-Chiong T, et al. Practice parameters for the medical therapy of obstructive sleep apnea. Sleep. 2006;29(8):1031-1035.
37. Black JE, Hirshkowitz M. Modafinil for treatment of residual excessive sleepiness in nasal continuous positive airway pressure-treated obstructive sleep apnea/hypopnea syndrome. Sleep. 2005;28(4):464-471. (Pubitemid 40489841)
38. Hirshkowitz M, Black JE, Wesnes K, Niebler G, Arora S, Roth T. Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. Respir Med. 2007;101(3):616-627. (Pubitemid 46196315)
39. Roth T, White D, Schmidt-Nowara W, 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;28(5):689-706. (Pubitemid 44067263)
40. Roth T, Rippon GA, Arora S. Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea. Sleep Breath. 2008;12(1):53-62.
41. Schwartz JR, Hirshkowitz M, Erman MK, Schmidt-Nowara W. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea: a 12-week open-label study. Chest. 2003;124(6):2192-2199. (Pubitemid 38010589)
42. Schwartz JR, Roth T. Shift work sleep disorder: burden of illness and approaches to management. Drugs. 2006;66(18):2357-2370. (Pubitemid 46072447)
43. McMenamin TM. A time to work: recent trends in shift work and flexible schedules. Month Lab Rev. Dec 2007:3-15. Available from: http://www.bls.gov/ opub/mlr/2007/12/art1full.pdf. Accessed Oct 15, 2009.
44. Waage S, Moen BE, Pallesen S, et al. Shift work disorder among oil rig workers in the North Sea. Sleep. 2009;32(4):558-565.
45. Czeisler CA, Walsh JK, Roth T, et al. Modafinil for excessive sleepiness associated with shift-work disorder. N Engl J Med. 2005;353(5): 476-486. (Pubitemid 41127292)
46. Czeisler CA, Walsh JK, Wesnes KA, Arora S, Roth T. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009;84(11): 958-972.
47. Erman MK, Rosenberg R; for the US Modafinil Shift Work Sleep Disorder Study Group. 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. (Pubitemid 46878737)
48. Hart CL, Haney M, Nasser J, Foltin RW. Combined effects of methamphetamine and zolpidem on performance and mood during simulated night shift work. Pharmacol Biochem Behav. 2005;81(3):559-568. (Pubitemid 40966803)
49. Longstreth WT Jr, Ton TG, Koepsell T, Gersuk VH, Hendrickson A, Velde S. Prevalence of narcolepsy in King County, Washington, USA. Sleep Med. 2009;10(4):422-426.
50. Wise MS, Arand DL, Auger RR, Brooks SN, Watson NF; for the American Academy of Sleep Medicine. Treatment of narcolepsy and other hypersomnias of central origin. Sleep. 2007;30(12):1712-1727.
51. US Xyrem Multicenter Study Group. A randomized, double-blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25(1):42-49.
52. US Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004;5(2):119-123.
53. Xyrem International Study Group. A double-blind placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1(4):391-397.
54. Xyrem International Study Group. Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo- controlled study in 228 patients. Sleep Med. 2005;6(5):415-421.
55. Harsh JR, Haydak R, Rosenberg R, et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006;22(4):761-774.
56. US Modafinil in Narcolepsy Multicenter Study Group. Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. Ann Neurol. 1998;43(1):88-97.
57. US Modafinil in Narcolepsy Multicenter Study Group. Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy. Neurology. 2000;54(5):1166-1175.
58. 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(3):281-288. (Pubitemid 29148551)
59. 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(1):30-40. (Pubitemid 29053150)
60. Ferraro L, Fuxe K, Tanganelli S, Tomasini MC, Rambert FA, Antonelli T. Differential enhancement of dialysate serotonin levels in distinct brain regions of the rat by modafinil: possible relevance for wakefulness and depression. J Neurosci Res. 2002;68(1):107-112. (Pubitemid 34275003)
61. Mitchell HA, Bogenpohl JW, Liles LC, et al. Behavioral responses of dopamine beta-hydroxylase knockout mice to modafinil suggest a dual noradrenergic - dopaminergic mechanism of action. Pharmacol Biochem Behav. 2008;91(2):217-222.
62. Qu WM, Huang ZL, Xu XH, Matsumoto N, Urade Y. Dopaminergic D1 and D2 receptors are essential for the arousal effect of modafinil. J Neurosci. 2008;28(34):8462-8469.
63. Food and Drug Administration. FDA-approved Labeling Text for NDA 21-875/NUVIGIL™ (armodafinil) Tablets; 2007 June 15. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2007/021875lbl.pdf. Accessed Oct 15, 2009.
64. Rao Y, Liu ZW, Borok E, et al. Prolonged wakefulness induces experience-dependent synaptic plasticity in mouse hypocretin/orexin neurons. J Clin Invest. 2007;117(12):4022-4033. (Pubitemid 350224111)
65. Beck P, Odle A, Wallace-Huitt T, Skinner RD, Garcia-Rill E. Modafinil increases arousal determined by P13 potential amplitude: an effect blocked by gap junction antagonists. Sleep. 2008;31(12):1647-1654.
66. Darwish M, Kirby M, Hellriegel ET, Robertson P Jr. Armodafinil and modafinil have substantially different pharmacokinetic profiles despite having the same terminal half lives: analysis of data from three randomized, single-dose, pharmacokinetic studies. Clin Drug Investig. 2009;29(9):613-623.
67. Darwish M, Kirby M, Hellriegel ET, Yang R, Robertson P Jr. Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies. Clin Drug Investig. 2009;29(2): 87-100.
68. Darwish M, Kirby M, Robertson P Jr, Hellriegel ET. Interaction profile of armodafinil with medications metabolized by cytochrome P450 enzymes 1A2, 3A4 and 2C19 in healthy subjects. Clin Pharmacokinet. 2008;47(1):61-74. (Pubitemid 350260889)
69. Wisor JP, Dement WC, Aimone L, Williams M, Bozyczko-Coyne D. Armodafinil, the R-enantiomer of modafinil: wake-promoting effects and pharmacokinetic profile in the rat. Pharmacol Biochem Behav. 2006;85(3):492-499. (Pubitemid 46097059)
70. Dinges DF, Arora S, Darwish M, Niebler GE. Pharmacodynamic 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(1): 159-167. (Pubitemid 43106919)
71. Black J, Hull SG, Tiller J, Yang R, Harsh JR. Maintenance of efficacy, safety and tolerability of armodafinil: an open-label extension study. Sleep. 2009;32 Suppl:A139 [Abstract No. 0419].
72. Schwartz JR, Khan A, McCall V, Weintraub J, Tiller J. A 12-month or more open-label study of the efficacy and tolerability of armodafinil. Sleep. 2009;32 Suppl:A50-A51 [Abstract No. 0148].
73. Schwartz JR, Becker PM, Tiller J, Bogan RK. Armodafinil improves patient-reported outcomes in patients with excessive sleepiness associated with obstructive sleep apnea or narcolepsy. Sleep. 2009;32 Suppl:A190 [Abstract No. 0580].
74. Krystal A, Harsh J, Yang R, Rippon G, Lankford A. A randomised, double-blind, placebo-controlled study with armodafinil in patients with residual excessive sleepiness associated with CPAP-treated obstructive sleep apnoea and comorbid depressive disorders. Poster presented at the 19th Meeting of the European Neurological Society, 2009 June 20-24, Milan, Italy [Abstract No. P353].
75. Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990;52(1-2):29-37.
76. Hull S, Lankford A, Vince B, Niebler GE, Arora S. Armodafinil improves fatigue in patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome. Poster presented at the American Psychiatric Association Annual Meeting, 2006 May 25, Toronto, Canada [Abstract No. 127].
77. Russo M. Pharmacotherapy of excessive sleepiness: focus on armodafinil. Clin Med Ther. 2009;1:415-432.
78. Bogan R, Tiller J, Yang R, Youakim J, Roth T. Armodafinil for excessive sleepiness associated with jet lag disorder. Sleep. 2009;32 Suppl:A52 [Abstract No. 0153].