Modafinil Tablets

Overview of Modafinil Tablets

Dosage Strength

Commercial (Provigil®): 100 mg, 200 mg
Commercial (Generic): 100 mg, 200 mg

General Information

Modafinil is a racemic substance with special abilities to enhance wakefulness; its mode of action seems to be different from those of other CNS stimulants. Modafinil appears to have a lower misuse liability than other regulated stimulants, while it is still a risk. In narcolepsy clinical studies, modafinil increased daytime vigilance as measured by reductions in the frequency and length of daytime sleep episodes. In clinical trials for narcolepsy, surveys of patient satisfaction found that modafinil reduces feelings of exhaustion and boosts mental alertness. 1 Modafinil has minimal impact on the frequency of cataplectic attacks connected to narcolepsy, and it appears to preferentially reduce somnolence while having no discernible effects on memory, concentration, learning, or sleep latency/sleep structure in narcoleptic patients. Modafinil has demonstrated potential in clinical trials as a therapy for fatigue or excessive drowsiness related to sleep apnea 2 or Parkinson’s disease because of its distinct pharmacologic profile. 1 The use of modafinil as an alternative to amphetamines to counteract fatigue during protracted combat missions is one of its proposed military applications. The first new molecular entity to be used in treating narcolepsy in 20 years, modafinil (Provigil) was FDA-approved for use in individuals with the condition in December 1998. Modafinil was approved by the FDA on October 24, 2003, for the treatment of shift work sleep disorder (SWSD), and on January 26, 2004, for the treatment of adults with obstructive sleep apnea/hypopnea syndrome (OSAHS). According to a phase III trial that used the DSM-IV ADHD Rating Scale, Cephalon Inc. stated in July 2000 that modafinil medication did not lessen the symptoms of attention-deficit hyperactivity disorder (ADHD) in adults when compared to a placebo. In children with narcolepsy, modafinil was no more beneficial than a placebo. Modafinil has not been shown to be safe or helpful for juvenile patients with any ailment. The FDA rejected pediatric approval of modafinil due to the risk of serious side effects, including cases of serious dermatologic reactions, Stevens-Johnson syndrome, potential dangers for hepatic impairment or multi-organ hypersensitivity, and reported psychiatric and other side effects in children. Modafinil was studied for ADHD in pediatric patients age 6 years and older. 3

References

1.Broughton RJ, Fleming JA, George CF. Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy. Neurology 1997;49:444-51.
2.Kingshott RN, Vennelle M, Coleman EL, et al. Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of residual excessive daytime sleepiness in the sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 2001
3.Provigil (modafinil) package insert. Frazer, PA: Cephalon; 2015 Jan.
4.Rammohan KW, Rosenberg JH, Lynn DJ, et al. Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study. J Neurol Neurosurg Psychiatry 2002;72:179-183.
5.Nieves AV, Lang AE. Treatment of excessive daytime sleepiness in patients with Parkinson’s disease with modafinil. Clin Neuropharmacol 2002;25:111-114.
6.DeBattista C, Doghramji K, Menza MA, et al; Modafinil in Depression Study Group. Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: a preliminary double-blind, placebo-controlled study. J Clin Psychiatry. 2003;64:1057-1064.
7.Fava M, Thase ME, DeBattista C, et al. A multicenter, placebo-controlled study of modafinil augmentation in partial responders to selective serotonin reuptake inhibitors with persistent fatigue and sleepiness. J Clin Psychiatry 2005;66:85-93.
8.Turner DC, Clark L, Dowson J, et al. Modafinil improves cognition and response inhibition in adult attention-deficit/hyperactivity disorder. Biol Psychiatry. 2004;55:1031-1040.
9.Arnold VK, Feifel D, Earl CQ, et al. A 9-week, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of modafinil as treatment for adults with ADHD. J Atten Disord. 2014;18:133-144. Epub 2012 May 22.
10.Kaplan S, Braverman DL, Frishman I, Bartov N. Pregnancy and fetal outcomes following exposure to modafinil and armodafinil during pregnancy. JAMA Intern Med 2020; Published online Oct. 19, 2020. doi:10.1001/jamainternmed.2020.4009.
11.Hackett LP, Kristensen JH, Hale TW, et al. Methylphenidate and breast-feeding. Ann Pharmacother 2006;40:1890-1.
12.Spigset O, Brede WR, Zahlsen K. Excretion of methylphenidate in breast milk. Am J Psychiatry 2007;164:348
13.American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.
14.Biederman J, Swanson JM, Wigal SB, et al. Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study. Pediatrics 2005;116:777-84
15.Bachot N, Roujeau JC. Differential diagnosis of severe cutaneous drug eruptions. Am J Clin Dermatol 2003;4:561-72

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