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

Clinical Drug Investigation

Volumn 29, Issue 9, 2009, Pages 613-623

  Darwish, Mona ^a   Kirby, Mary ^a   Hellriegel, Edward T ^a   Robertson Jr , Philmore ^a  

^a CEPHALON INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARMODAFINIL; MODAFINIL; PLACEBO;

ABDOMINAL PAIN; ANEMIA; ANXIETY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CLINICAL TRIAL; CONFUSION; CONTACT DERMATITIS; CONTROLLED CLINICAL TRIAL; DATA ANALYSIS; DEHYDRATION; DIZZINESS; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG TOLERABILITY; DYSPEPSIA; ENERGY; FATIGUE; HALF LIFE TIME; HEADACHE; HEART RATE; HEAT SENSATION; HUMAN; HYPERESTHESIA; INFECTION; INSOMNIA; INTRAOCULAR HEMORRHAGE; ISOMER; LABORATORY TEST; LEG CRAMP; LIMB PAIN; LOGORRHEA; MYALGIA; NARCOLEPSY; NAUSEA; NERVOUSNESS; PARESTHESIA; PHARYNGITIS; PRIORITY JOURNAL; PRURITUS; RACEMIC MIXTURE; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SHIFT WORKER; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SLEEP APNEA SYNDROME; SOMNOLENCE; SUBCUTANEOUS TISSUE; THIRST; THORAX PAIN; TREMOR; URINARY FREQUENCY; WAKEFULNESS; XEROSTOMIA;

ADOLESCENT; ADULT; BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STEREOISOMERISM; TIME FACTORS;

EID: 68949098308     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11315280-000000000-00000     Document Type: Article

References (16)

1. 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): 616-627
2. 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
3. Czeisler CA, Walsh JK, Wesnes KA, et al. A randomized clinical trial of armodafinil for the treatment of excessive sleepiness associated with shift-work disorder. Mayo Clin Proc. In press
4. 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): 761-774
5. Data on file, Cephalon, Inc., Frazer, PA, USA: Jul 2009
6. 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
7. 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): 281-288
8. Robertson Jr P, Hellriegel ET. Clinical pharmacokinetic profile of modafinil. Clin Pharmacokinet 2003; 42 (2): 123-137
9. 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
10. Darwish M, Kirby M, Hellriegel ET. Comparison of steady- state plasma concentrations of armodafinil and modafinil late in the day following morning administration. Clin Drug Investig 2009; 29 (9): ((To come))
11. Schwartz JR, Nelson MT, Schwartz ER, et al. Effects of modafinil on wakefulness and executive function in patients with narcolepsy experiencing late-day sleepiness. Clin Neuropharmacol 2004 Mar-Apr; 27 (2): 74-79
12. Schwartz JR, Feldman NT, Bogan RK, et al. Dosing regimen effects of modafinil for improving daytime wakefulness in patients with narcolepsy. Clin Neuropharmacol 2003 Sep-Oct; 26 (5): 252-257
13. Schwartz JR, Feldman NT, Bogan RK. Dose effects of modafinil in sustaining wakefulness in narcolepsy patients with residual evening sleepiness. J Neuropsychiatry Clin Neurosci 2005 Summer; 17 (3): 405-412
14. 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): 159-167
15. International Conference on Harmonisation 1996. Guideline for good clinical practice, E6(R1). International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use; 1996 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ich/013595en. pdf [Accessed 2009 Jul 23]
16. 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 Mar; 12 (1): 53-62