Modafinil: Preclinical, Clinical, and Post-Marketing Surveillance—A Review of Abuse Liability Issues

References

• Duteil J, Rambert FA, Pesssonnier J, Hermant JF, Gombert R, Assous E. Central alpha 1-adrenergic stim-ulation in relation to the behaviour stimulating effect of modafinil: studies with experimental animals. Eur J. Pharmacol 1990; 180:49–58.
   PubMed Web of Science ®Google Scholar
• Simon P, Hemet C, Ramassamy C, Costentin J. Non-amphetaminic mechanism of stimulant locomotor effect of modafinil in mice. Eur Neuropsychopharma-col 1995; 4:509–514.
   Google Scholar
• Edgar DM, Seidel WE. Modafinil induces wakefulness without intensifying motor activity or subsequent rebound hypersomnolence in the rat. J Pharmacol Exp Ther 1997; 283(2), 757–769.
   PubMed Web of Science ®Google Scholar
• US Modafmil in Narcolepsy Multicenter Study Group. Randomized trial of modafmil as a treatment for the excessive daytime somnolence of narcolepsy. Neurol-ogy 1998; 54(5):1166–1175.
   Google Scholar
• Taylor FB, Russo J. Efficacy of modafinil compared to dextroamphetamine for the treatment of attention-deficit-hyperactivity disorder in adults. J Child Adolesc Psychopharmacol 2000; 10(4):311–320.
   PubMed Web of Science ®Google Scholar
• Rugino TA, Copley TC. Effect of modafinil in children with attention-deficit/hyperactivity disorder: An open-label study. J Am Acad Child Adolesc Psychiatry 2001; 40(2): 230–235.
   Google Scholar
• Menza MA, Kaufman KR, Castellanos A. Modafinil augmentation of antidepressant treatment in depression. J Clin Psychiatry 2000; 61(5):378–381.
   Google Scholar
• Kaufman KR, Menza MA, Fitzsimmons A. Modafmil monotherapy in depression. Eur Psychiatry 2002; 17(3): 167–169.
   Google Scholar
• Kingshott RN, Vennelle M, Coleman EL, Engleman HM, Mackay TW, Douglas NJ. Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of residual excessive daytime sleepiness in the sleep apnea/hyopnea syndrome. Am J Respir Crit Care Med 2001; 163 :918–923 .
   PubMed Web of Science ®Google Scholar
• Pack AT, Black JE, Schwartz JR, Matheson JK. Modafi-nil as adjunct therapy for daytime sleepiness in obstruc-tive sleep apnea. Am J Respir Crit Care Med 2001; 163:918–923.
   Google Scholar
• Black JE, Douglas NJ, Earl CQ, Modafinil OSA Study Group. Efficacy and safety of modafinil as adjunctive therapy for excessive sleepiness associated with obs-tructive sleep apnea (abstract). Sleep 2002: 25(Suppl 1): A22.
   Google Scholar
• Hogl B, Saleto M, Brandauer E, Glatzl S, Frauscher B, Seppi K, Ulmer H, Wenning G, Poewe W. Modafinil for the treatment of daytime sleepiness in Parkinson's dis-ease: a double-blind, randomized, crossover, placebo-controlled polygraphic trial. Sleep 2002: 25(8):905–909.
   Google Scholar
• Adler CH, Caviness JN, Hentz JG, Lind M, Tiede J. Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease. Mov Disord 2003; 13(3):287–293.
   Google Scholar
• Rammohan KW, Rosenberg JH, Lynn DJ, Blumenfeld AM, Pollak CP, Nagaraja FIN. Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in mul-tiple sclerosis: a two center phase 2 study. J Neurol Neurosurg Psychiatry 2002; (2):179–183.
   Google Scholar
• Zifko UA, Rupp M, Schwarz S, Zipko HT, Maida EM. Modafmil in treatment of fatigue in multiple sclerosis. Results of an open-label study. J Neurol 2002; 249(8): 983–987.
   Google Scholar
• Provigile (modafinil) Package Insert: Cephalon, Inc., West Chester, PA, 2002. Available at: http://www. provigil.com
   Google Scholar
• Robertson P Jr., Hellriegel ET. Clinical pharmacoki-netic profile of modafinil. Clin Pharmacokinet 2003; 42(2):123–137.
   Google Scholar
• Lin JS, Hou Y, Jouvet M. Potential brain neuronal targets for amphetamine-, methylphenidate-, and modafinil-induced wakefulness, evidenced by c-fos immunocytochemistry in the cat. Proc Natl Acad Sci USA 1996; 98(24):14128–14133.
   Google Scholar
• Engber TM, Koury EJ, Dennis SA, Miller MS, Contreras PC, Bhat RV. Differential patterns of regional c-Fos induction in the rat brain by amphetamine and the novel wakefulness-promoting agent modafinil. Neurosci Lett 1998; 241(2-3):95–98.
   PubMed Web of Science ®Google Scholar
• Scammel TE, Estabrooke IV, McCarthy MT, et al. Hypothalamic arousal regions are activated during Modafmil-induced wakefulness. Journal of Neuro-science 2000; 20(22):8620–8628.
   Google Scholar
• Mignot E, Nishino S, Guilleminault C, Dement WC. Modafmil binds to the dopamine uptake carrier site with low affinity. Sleep 1994; 17(5):436–437.
   PubMed Web of Science ®Google Scholar
• Roth BL. Personal Communication. July 10,2003.
   Google Scholar
• Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakeful-ness. J Neurosci 2001; 21(5):1787–1794.
   PubMed Web of Science ®Google Scholar
• Stone EA, Cotecchia S, Lin Y, Quartermain D. Role of brain alpha 1B adrenoreceptors in modafmil-induced behavioral activity. Synapse 2002; 42:269–270.
   Google Scholar
• Ferraro L, Antonelli T, O'Connor WT, et al. Modafinil: an antinarcoleptic drug with a different neurochemical profile to d-amphetamine and dopamine uptake block-ers. Biol Psychiatry 1997; 42:1181–1183.
   Google Scholar
• Perez de la Mora M, Aguilar-Garcia A, Ramon-Frias T, et al. Effects of the vigilant-promoting drug modafmil on the synthesis of GABA and glutamate in slices of rat hypothalamus. Neuroscience Letter 1999; 259:181–185.
   Google Scholar
• Antonelli T, Ferraro L, HiIlion J, Tomasini MC, Rambert FA, Fuxe K. Modafinil prevents glutamate cytotoxicity in cultured cortical neurons. Neuroreport 1998; 9(18):4209–4213.
   Google Scholar
• Jenner P. Zeng BY, Smith LA, et al. Antiparkinsonian and neuroprotective effects of modafinil in the MPTP-treated common marmoset. Exp Brain Res. 2000; 133(2):178–188.
   Google Scholar
• Davidson C, Gow AJ, Lee TH, Ellinwood EH. Meth-amphetamine neurotoxicity: necrotic and apoptotic mechanisms and relevance to human abuse and treat-ment. Brain Res Brain Res Rev 2001; 36(1):1–22.
   Google Scholar
• McCann UD, Eligulashvili V. Ricaurte, GA: (+/-) 3,4-Methylenedioxymethamphetamine ('Ecstasy')-induced serotonin neurotoxicity: clinical studies. Neuropsycho-biology 2000; 42(1):11–16.
   PubMed Web of Science ®Google Scholar
• Gold LH, Balster RL. Evaluation of the cocaine like discriminative stimulus effects and reinforcing effects of modafinil. Psychopharmacol 1996; 126:286–292.
   PubMed Web of Science ®Google Scholar
• Deroche-Gamonet V. Darnaudery M, Bruins-Slot L, Piat F, Le Moal M, Piazza PV. Study of the addictive potential of modafmil in naïve and cocaine-experienced rats. Psychopharmacology (Berl) 2002; 161(4):387–395.
   Google Scholar
• Vocci FJ Jr. The necessity and utility of abuse liability evaluations in human subjects: the FDA perspective. Testing for abuse liability of drugs in humans. Bethesda, Md: National Institute on Drug Abuse; 1989 NIDA Research Monograph 92:7-20. Available at: http://www. drugabuse.gov/pdf/monographs/download92.html
   Google Scholar
• Warot D, Corruble E, Payan C, Weil JS, Puech AJ. Subjective effects of modafmil, a new centeral adrener-gic stimulant in healthy volunteers: a comparison with amphetamine, caffeine, and placebo. Eur Psychiatry 1993; 8:201–208.
   Google Scholar
• Jasinski DR. Distinguishing modafinil from meth-ylphenidate in a study of abuse potential: gender com-parison. Presented at the Annual Meeting of the College on Problems of Drug Dependence, June 14–19, 1997, Nashville, TN.
   Google Scholar
• Jasinski DR, Kovacevic-Ristanovi CR. Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with nar-colepsy. Clinical Neuropharmacology 2000; 23(3): 149–156.
   Google Scholar
• Rush CR, Kelly TH, Hays LR, Baker RW, Wooten AF. Acute behavioral and physiological effects of modafinil in drug abusers. Behavioural Pharmacology 2002; 13(2): 105–115.
   Google Scholar
• Rush CR, Kelly TH, Hays LR, Wooten AF. Discrimi-native-stimulus effects of modafinil in cocaine-trained humans. Drug and Alcohol Dependence 2002; 67: 311–322.
   PubMed Web of Science ®Google Scholar
• Dackis CA, Lynch KG, Yu E, et al. Modafmil and cocaine: a double-blind, placebo-controlled drug inter-action study. Drug Alcohol Depend 2003; 70(1):29–37.
   PubMed Web of Science ®Google Scholar
• Westensten NJ, Belenky G, Kautz MA, Thorne DR, Reichardt RM, Balkin TJ. Maintaining alertness and performance during sleep deprivation: modafinil versus caffeine. Psychopharmacology 2002; 159:238–247.
   PubMed Web of Science ®Google Scholar
• Malcolm R, Devane L, Donovan J, et al. Modafmil dampens multiple aspects of intravenous cocaine high. Unpublished. Presented June 15, 2003; College of Problems of Drug Dependence, Bal Harbour, FL.
   Google Scholar
• Jasinski DR. An evaluation of the abuse potential of modafinil using methylphenidate as a reference. Jour-nal of Psychopharmacology 2000; 14(1):53–60.
   PubMed Web of Science ®Google Scholar
• Galloway G. Personal Communication. June 15,2003.
   Google Scholar
• Malcolm R, Book S, Moak D, DeVane L, Czepowicz V. Clinical applications of modafmil in stimulant abusers: low abuse potential. Am J Addictions 2002; 11:247–249.
   Google Scholar