Armodafinil

CNS Drugs

Volumn 23, Issue 9, 2009, Pages 793-803

  Garnock Jones, Karly P ^a,b   Dhillon, Sohita ^a,b   Scott, Lesley J ^a,b  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b WOLTERS KLUWER HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHETAMINE; ARMODAFINIL; CONTRACEPTIVE AGENT; CYCLOSPORIN A; DEXAMPHETAMINE; DIAZEPAM; METHYLPHENIDATE; MIDAZOLAM; MODAFINIL; OMEPRAZOLE; PHENYTOIN; PLACEBO; TRIAZOLAM; WARFARIN;

ALKALINE PHOSPHATASE BLOOD LEVEL; ANGIONEUROTIC EDEMA; AREA UNDER THE CURVE; BRAIN REGION; BRONCHOSPASM; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; COMPARATIVE STUDY; DEPRESSION; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EXCRETION; DRUG MECHANISM; DRUG METABOLISM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPHAGIA; EVENING DOSAGE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HEART RATE; HUMAN; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NARCOLEPSY; NAUSEA; NONHUMAN; PHARMACODYNAMICS; POPULATION; PRIORITY JOURNAL; RASH; RATING SCALE; RECIPIENT; RECOMMENDED DRUG DOSE; REVIEW; SHIFT WORK SLEEP DISORDER; SIDE EFFECT; SLEEP; SLEEP APNEA SYNDROME; SLEEP DISORDER; SOMNOLENCE; STEVENS JOHNSON SYNDROME; SYSTOLIC BLOOD PRESSURE; THERAPY EFFECT; TREATMENT DURATION; TREATMENT INDICATION; VOLUNTEER; WAKEFULNESS; XEROSTOMIA;

BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; CLINICAL TRIALS AS TOPIC; HUMANS; NARCOLEPSY; SLEEP APNEA, OBSTRUCTIVE; SLEEP DISORDERS, CIRCADIAN RHYTHM; STEREOISOMERISM; WAKEFULNESS;

EID: 68949208579     PISSN: 11727047     EISSN: 11791934     Source Type: Journal    
DOI: 10.2165/11203290-000000000-00000     Document Type: Review

References (23)

1. Managing excessive daytime sleepiness in adults. Drug Ther Bull 2004 Jul; 42 (7): 52-6
2. American Academy of Sleep Medicine. International classification of sleep disorders. 2nd ed. Diagnostic and coding manual. Westchester (IL): American Academy of Sleep Medicine, 2005
3. Nishino S, Okuro M. Armodafinil for excessive daytime sleepiness. Drugs Today 2008 Jun; 44 (6): 395-414
4. Sherman BW, Strohl KP. Management of shift work sleep disorder: Alice in Wonderland redux? J Occup Environ Med 2004 Oct; 46 (10): 1010-2
5. Keating GM, Raffin MJ. Modafinil: a review of its use in excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder. CNS Drugs 2005; 19 (9): 785-803
6. Cephalon Inc. Provigil® (modafinil tablets): US prescribing information [online]. Available from URL: http://provigil.com/media/PDFs/ prescribing-info.pdf [Accessed 2009 Jun 22]
7. Dinges DF, Arora S, Darwish M, et al. 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 Jan; 22 (1): 159-67
8. 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 Mar; 39 (3): 281-8
9. 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 Jan; 39 (1): 30-40
10. Cephalon Inc. Nuvigil® (armodafinil tablets): US prescribing information [online]. Available from URL: http://nuvigil.com/pdf/PI.pdf [Accessed 2009 Apr 9]
11. Fiocchi EM, Lin YG, Aimone L, et al. Armodafinil promotes wakefulness and activates Fos in rat brain. Pharmacol Biochem Behav 2009 Feb 26; 92 (3): S49-57
12. Myrick H, Malcolm R, Taylor B, et al. Modafinil: preclinical, clinical, and post-marketing surveillance: a review of abuse liability issues. Ann Clin Psychiatry 2004 Apr-Jun; 16 (2): 101-9
13. Wisor JP, Dement WC, Aimone L, et al. R-modafinil (armodafinil) produces dose-dependent increases in wake in rat without rebound hypersomnolence [abstract no. 310.3]. 2005 Annual Meeting of the Society for Neuroscience; 2005 Nov 12-16; Washington, DC
14. Darwish M, Kirby M, Hellriegel ET, et al. Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies. Clin Drug Investig 2009; 29 (2): 87-100
15. Darwish M, Kriby M, Robertson Jr P, et al. 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
16. Robertson Jr P, Hellriegel ET. Clinical pharmacokinetic profile of modafinil. Clin Pharmacokinet 2003; 42 (2): 123-37
17. US FDA. US FDA clinical review of armodafinil [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/021875s000-MedR-P2. pdf [Accessed 2009 Jun 24]
18. Roth T, Czeisler CA, Walsh JK, et al. Randomized, double-blind, placebo-controlled study of armodafinil for the treatment of excessive sleepiness associated with chronic shift work sleep disorder [abstract no. 161]. Neuropsychopharmacology 2005; 30 Suppl. 1: S140. Plus poster presented at the 44th Annual Meeting of the American College of Neuropsychopharmacology; 2005 Dec 11-15; Waikoloa (HI)
19. Harsh JR, Hayduk 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 Apr; 22 (4): 761-74
20. Hirshkowitz M, Black JE, Wesnes K, et al. Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. Respir Med 2007 Mar; 101 (3): 616-27
21. 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 May; 28 (5): 689-706
22. Bogan R, Hirshkowitz M, Neibler G, et al. Armodafinil improves wakefulness and memory in nCPAP compliant patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome [abstract no. 805]. Proceedings of the American Thoracic Society 2006 Apr 1; 3 (Abstr. Suppl.): 872. Plus poster presented at the International Conference of the American Thoracic Society; 2006 May 19-24; San Diego (CA)
23. Data on file, Cephalon Inc., 2009