Modafinil_ Drug Information

7/25/2019 Modafinil_ Drug Information

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10/21/2015 Modafinil: Drug information

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Official reprint from UpToDatewww.uptodate.com 2015 UpToDate

Modafinil: Drug information

Copyright 1978-2015 Lexicomp, Inc. All rights reserved.

(For additional information see "Modafinil: Patient drug information"and see "Modafinil: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: US Provigil

Brand Names: Canada Alertec Apo-Modafinil Mar-Modafinil Teva-Modafinil

Pharmacologic Category Central Nervous Syst em Stimulant

Dosing: Adult

US labeling:

Narcolepsy, obstructive sleep apnea (OSA):Oral: Initial: 200 mg as a single daily dose in the morning. Note:Doses up to 400 mg once daily have

been well tolerated, but there is no consistent evidence that this dose confers additional benefit.

Shift work sleep disorder (SWSD):Oral: Initial: 200 mg as a single dose ~1 hour prior to start of work shift

Canadian labeling:

Narcolepsy: Oral: Initial: 200 mg daily in 2 divided doses (first dose in the morning and second dose at noon [or no later than early afternoon]) may

titrate dose upward in 100 mg increments as needed and tolerated (maximum single dose: < 300 mg maximum daily dose: 400 mg). Single

doses 300 mg and daily doses >400 mg are associated with increased side effects and are not recommended.

Obstructive sleep apnea:Oral: 200 mg once daily in the morning.

Shift work sleep disorder (SWSD):Oral: 200 mg as a single dose taken ~1 hour prior to start of work shift

Off-label uses:

Attention-deficit/hyperactivity disorder (ADHD) (off-label use):100 to 400 mg daily (Taylor 2000)

Multiple sclerosis-related fatigue (off-label use): 100 mg once daily initially, increased as tolerated to 200 mg once daily or if patient experiences

post-noon fatigue, 100 mg twice daily (ie, morning and noon). Higher daily doses (greater than 200 mg) do not appear to be effective (Brown

2010 Moller 2011 Rammohan 2002 Stankoff 2005 Zifko 2002).
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Dosing: Geriatric Consider initiating at lower doses.

Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturers labeling.

Dosing: Hepatic Impairment

Mild to moderate hepatic impairment: There are no dosage adjustments provided in the manufacturers labeling.

Severe hepatic impairment: Dose should be reduced to one-half of that recommended for patients with normal liver function.

Dosage Forms: US Excipient information presented when available (limited, particularly for generics) consult specif ic product labeling.

Tablet, Oral:

Provigil: 100 mg

Provigil: 200 mg [scored]

Generic: 100 mg, 200 mg

Dosage Forms: Canada Excipient information presented when available (limited, particularly for generics) consult specif ic product labeling.

Tablet, oral: 100 mg

Alertec: 100 mg

Generic Equivalent Available: US Yes

Controlled Substance C-IV

Medication Guide and/or Vaccine Information Statement (VIS) An FDA-approved patient medication guide, which is available withthe product information and at http://www .fda.gov/downloads/Drugs/DrugSafety/UCM231722.pdf, must be dispensed with this medication.

Administration

US labeling:For the treatment of narcolepsy and obstructive sleep apnea/hypopnea syndrome, administer dose in the morning. For the treatment of shift

work sleep disorder, administer dose ~1 hour prior to start of work shift.

Canadian labeling:For the treatment of narcolepsy, administer in 2 divided doses with first dose given in the morning and the second dose given at noon

(or no later than early afternoon) to avoid potential for insomnia. For treatment of obstructive sleep apnea, administer as a single dose in the morning.

For the treatment of shift work sleep disorder, administer dose ~1 hour prior to start of work shift.

Use
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Narcolepsy: To improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy.

Obstructive sleep apnea: To improve wakefulness in adult patients with obstructive sleep apnea (OSA)

Shift work sleep disorder: To improve wakefulness in adult patients with shift work sleep disorder (SWSD)

Use: Off-Label

Attention-deficit/hyperactivity disorder Fatigue in adult cancer survivors Multiple sclerosis-related fatigue

Adverse Reactions Significant

Frequency not always defined.

Cardiovascular: Chest pain (3%), hypertension (3%), palpitations (2%), tachycardia (2%), vasodilatation (2%), edema (1%)

Central nervous system: Headache (adults 34% children 20% [Biederman 2005] dose related), nervousness (7%), anxiety (5% dose related),

dizziness (5%), insomnia (5%), depression (2%), drowsiness (2%), paresthesia (2%), agitation (1%), chills (1%), confusion (1%), emotional

lability (1%), hypertonia (1%), vertigo (1%)

Dermatologic: Diaphoresis (1%)

Endocrine & metabolic: Weight loss (children 5% [Greenhill 2006]), increased thirst (1%), increased gamma-glutamyl transferase

Gastrointestinal: Decreased appetite (children 16% [Biederman 2005]), abdominal pain (children 12% [Greenhill 2006]), nausea (11%), diarrhea (6%),

dyspepsia (5%), xerostomia (4%), anorexia (4%), constipation (2%), dysgeusia (1%), flatulence (1%), oral mucosa ulcer (1%)

Genitourinary: Urine abnormality (1%)

Hematologic & oncologic: Eosinophilia (1%)

Hepatic: Abnormal hepatic function tests (2%), increased serum alkaline phosphataseNeuromuscular & skeletal: Back pain (6%), dyskinesia (1%), hyperkinesia (1%), tremor (1%)

Ocular: Abnormal vision (1%)

Respiratory: Rhinitis (7%), pharyngitis (4%), asthma (1%), epistaxis (1%)


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Hypersensitivity to modafinil, armodafinil, or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Patients in agitated states or with severe anxiety

Warnings/Precautions

Concerns related to adverse effects:

CNS effects: May impair the ability to engage in potentially hazardous activities patients must be cautioned about performing tasks which requiremental alertness (eg, operating machinery or driving).

Dermatologic effects (severe): Serious and life-threatening rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash

with eosinophilia and systemic symptoms (DRESS) have been reported. Although initially reported in children during clinical trials,

postmarketing cases have occurred in both children and adults. Most cases have occurred within the first 5 weeks of therapy however, rare

cases have occurred after long-term use (eg, 3 months). No risk factors have been identified to predict occurrence or severity. Patients should

be advised to discontinue at first sign of rash (unless the rash is clearly not drug-related). As a result of these serious dermatologic adverse

events, approval for the use of modafinil in children for ADHD was denied by the FDA.

Hypersensitivity reactions: Rare cases of multiorgan hypersensitivity reactions (with fatality) in association with modafinil use lone cases of

angioedema and anaphylactoid reactions with armodafinil have been reported (angioedema has been noted in postmarketing reports withmodafinil). Signs and symptoms are diverse, reflecting the involvement of specific organs patients typically present with fever and rash

associated with organ-system dysfunction. No risk factors have been identified to predict occurrence or severity of multiorgan hypersensitivity

reactions. Patients should be advised to report any signs and symptoms related to these effects discontinuation of therapy is recommended.

Disease-related concerns:

Cardiovascular disease: Use with caution in patients with cardiovascular disease increased blood pressure and heart rate monitoring may be

required. Use is not recommended in patients with a history of left ventricular hypertrophy or patients with mitral valve prolapse who have

developed mitral valve prolapse syndrome with previous CNS stimulant use. Increased monitoring should be considered in patients with a

recent history of myocardial infarction or unstable angina. Hepatic impairment: Use with caution in patients with hepatic impairment. Dosage reduction is recommended in patients with severe hepatic

impairment.

Psychiatric disorders: Use with caution in patients with a history of psychosis, depression, or mania. Use may result in emergence of or

exacerbation of psychiatric symptoms. Observe for symptoms of aggression, hallucinations, mania, delusions, or suicidal ideation. Consider

discontinuing therapy if psychiatric symptoms develop.

Renal impairment: Use with caution in patients with renal impairment.

Sleep disorders: Appropriate use: The degree of sleepiness should be reassessed frequently some patients may not return to a normal level of

wakefulness. In obstructive sleep apnea, modafinil is indicated as treatment for excessive sleepiness and not for the underlying obstruction. Ifcontinuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period


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(For additional information: Launch Lexi-Interact Drug Interactions Program

)

of time should be made prior to initiating and during treatment with modafinil for excessive sleepiness.

Tourette syndrome: Use with caution in patients with Tourette syndrome limited evidence suggests stimulants may exacerbate tics and Tourette

syndrome (AACAP [Murphy, 2013] Pringsheim, 2012 Rossner, 2011).

Special populations:

Pediatric: Modafinil is not FDA-approved for use in pediatrics for any indication. Serious skin reactions and psychiatric events have been observed

in pediatric patients treated with modafinil. The serious nature of these adverse effects resulted in the FDAs Pediatric Advisory Committee

unanimously recommending that a specific warning against the use of modafinil in children be added to the manufacturers labeling.

Other warnings/precautions:

Ethanol use: Instruct patients to avoid concomitant ethanol consumption.

Metabolism/Transport Effects Substrate of CYP3A4 (major) Note: Assignment of Major/Minor substrate status based on clinically relevantdrug interaction potential Inhibits CYP2A6 (weak), CYP2C19 (moderate), CYP2C9 (weak), CYP2E1 (weak) Induces CYP1A2 (weak/moderate),

CYP2B6 (weak/moderate), CYP3A4 (moderate)

Drug Interactions

Antihepaciviral Combination Products: C YP3A4 Inducers (Moderate) may decrease the serum concentration of Antihepaciviral Combination Products.

Risk X: Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

ARIPiprazole: CYP3A4 Inducers may decrease the serum concentration of AR IPiprazole. Management: Double the oral aripiprazole dose and closely

monitor clinical response. Reduce the oral aripiprazole dose to 10-15 mg/day if the inducer is discontinued. Avoid use of CYP3A4 inducers for more

than 14 days with extended-release injectable aripiprazole. Risk D: Consider therapy modificationAtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics.

Risk C: Monitor therapy

Axitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Axitinib. Risk X: Avoid combination

Bedaquiline: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bedaquiline. Risk X: Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Bosutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bosutinib. Risk X: Avoid combination

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: Monitor therapy
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Cilostazol: CYP2C19 Inhibitors may increase the serum concentration of Cilostazol. Management: Consider reducing the cilostazol dose to 50 mg twice

daily in patients who are also receiving inhibitors of CYP2C19. Risk D: Consider therapy modification

Citalopram: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of

20 mg/day if used with a moderate CYP2C19 inhibitor. Patients using this combination should be monitored closely for evidence of citalopram

toxicity (e.g., serotonin syndrome, QT prolongation, etc.). Risk D: Consider therapy modification

Clarithromycin: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Clarithromycin. CYP3A4 Inducers

(Moderate) may decrease the serum concentration of Clarithromycin. Management: Consider alternative antimicrobial therapy for patients receiving aCYP3A inducer. Drugs that enhance the metabolism of clarithromycin into 14-hydroxyclarithromycin may alter the clinical activity of clarithromycin

and impair its efficacy. Risk D: Consider therapy modification

Clopidogrel: CYP2C19 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Due to a risk

for impaired clopidogrel effectiveness with such a combination, carefully consider the need for a moderate CYP2C19 inhibitor in patients receiving

clopidogrel. Monitor patients closely for evidence of a diminished response to clopidogrel. Risk D: Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination

Contraceptives (Estrogens): Modafinil may decrease the serum concentration of Contraceptives (Estrogens). Management: The manufacturer

recommends that patients use nonhormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month followingtreatment with modafinil. Risk D: Consider therapy modification

CycloSPORINE (Systemic): Modafinil may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP2C19 Substrates: CYP2C19 Inhibitors (Moderate) may decrease the metabolism of CYP2C19 Substrates. Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs.

Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification

CYP3A4 Substrates: CYP3A4 Inducers (Moderate) may decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If

concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy

modification

Daclatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg

once daily if used with a moderate CYP3A4 inducer. Risk D: Consider therapy modificationDasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy


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Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates

that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution

and close monitoring. Risk D: Consider therapy modification

FentaNYL: CYP3A4 Inducers (Moderate) may decrease the serum concentration of FentaNYL. Risk C: Monitor therapy

Flibanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Flibanserin. Risk X: Avoid combination

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination

Hydrocodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Hydrocodone. Risk C: Monitor therapy

Ibrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ibrutinib. Management: Although moderate CYP3A inducers are not

specifically contraindicated with ibrutinib, prescribing information indicates that they may decrease AUC up to 3-fold. If possible, alternatives with

less CYP3A induction should be considered. Risk D: Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates.Risk X: Avoid combination

Ifosfamide: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Ifosfamide. CYP3A4 Inducers (Moderate)

may increase serum concentrations of the active metabolite(s) of Ifosfamide. Risk C: Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely

monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. RiskD: Consider therapy modification

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Mifepristone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for

increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine,

fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted

substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy


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NiMODipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of NiMODipine. Risk C: Monitor therapy

Nisoldipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nisoldipine. Risk X: Avoid combination

Olaparib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olaparib. Risk X: Avoid combination

Palbociclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Palbociclib. Risk X: Avoid combination

Ranolazine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ranolazine. Risk X: Avoid combination

Rolapitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Rolapitant. Management: Monitor for reduced rolapitant response.

Recommended dexamethasone regimens should be used with rolapitant. Higher dexamethasone doses or more prolonged use may increase the

potential for a significant interaction. Risk C: Monitor therapy

Saxagliptin: CYP3A4 Inducers may decrease the serum concentration of Saxagliptin. Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Simeprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Simeprevir. Risk X: Avoid combination

Sofosbuvir: Modafinil may decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Sonidegib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sonidegib. Risk X: Avoid combination

St Johns Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs.

Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered

to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with

stiripentol requires closer monitoring. Risk D: Consider therapy modification

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C:Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Food Interactions Food delays absorption, but does not affect bioavailability . Management: Administer without regard to meals.

Pregnancy Risk Factor C (show table)

Pregnancy Implications Adverse events have been observed in some animal reproduction studies. An increased risk of spontaneous abortion

and intrauterine growth restriction has been reported with modafinil. Efficacy of steroidal contraceptives (including depot and implantable contraceptives)may be decreased alternate means of contraception should be considered during therapy and for 1 month after modafinil is discontinued.
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Health care providers are encouraged to register pregnant patients exposed to modafinil, or pregnant women may enroll themselves, by calling (866-404-

4106).

Breast-Feeding Considerations It is not known if modafinil is excreted in breast milk. The manufacturer recommends that caution beexercised when administering modafinil to nursing women.

Pricing: US

Tablets(Modafinil Oral)

100 mg (30): $662.00

200 mg (30): $1000.08

Tablets(Provigil Oral)

100 mg (30): $972.00

200 mg (30): $1468.80

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product,respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for

reimbursement or purchasing functions. Pricing data is updated monthly.

Monitoring Parameters Levels of sleepiness blood pressure heart rate increased monitoring in patients with recent MI or unstable anginadevelopment of severe skin reactions development or exacerbation of psychiatric symptoms (eg, agitation, anxiety, depression)

When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior

to initiation (Vetter, 2008).

International Brand Names Activigil (UY) Alertex (CL, EC) Aspendos (RO) Carim (CR, D O, EC, GT, HN, NI, PA, SV, U Y) Forcilin (AR)Intensit (AR) Mentix (CL) Modalert (IN) Modanil (KR) Modasomil (AT, CH) Modavigil (AU, NZ) Modfil (IN) Modiodal (DK, ES, FR, GR, IS, JP, MX,NL, NO, PT, SE, TR) Movigil (CL) Nopral (AR) Provake (IN) Provigil (BE, GB, IE, IL, IT, KR, MT, PY, SG, TW, ZA) Resotyl (CL, PE) Stavigile(BR) Vigia (CO) Vigicer (AR) Vigil (CZ, DE) Zalox (CL)

Mechanism of Action The exact mechanism of act ion is unclear, it does not appear to alter the release of dopamine or norepinephrine, it mayexert its stimulant effects by decreasing GABA-mediated neurotransmission, although this theory has not yet been fully evaluated several studies also

suggest that an intact central alpha-adrenergic system is required for modafinil's activity the drug increases high-frequency alpha waves while

decreasing both delta and theta wave activity, and these effects are consistent with generalized increases in mental alertness

Pharmacodynamics and Pharmacokinetics Modafinil is a racemic compound (10% S-isomer and 90% R-isomer at steady state) whose


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enantiomers have different pharmacokinetics

Distribution: V : 0.9 L/kg

Protein binding: ~60%, primarily to albumin

Metabolism: Hepatic multiple pathways including CYP3A4

Half-life elimination: Effective half-life: 15 hours

Time to peak, serum: 2 to 4 hours may be delayed ~1 hour with food.

Excretion: Urine (80% as metabolites,


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13. Provigil (modafinil) [prescribing information]. Frazer, PA: Cephalon Inc January 2015.

14. Rammohan KW, Rosenberg JH, Lynn DJ, Blumenfeld AM, Pollak CP, Nagaraja HN. Efficacy and safety of modafinil (Provigil)for the treatment of fatigue in multiplesclerosis: a two centre phase 2 study. J Neurol Neurosurg Psychiatry. 200272(2):179-183. [PubMed 11796766]

15. Roessner V, Plessen KJ, Rothenberger A, et al ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II:pharmacological treatment. Eur Child Adolesc Psychiatry . 201120(4):173-196. [PubMed21445724]

16. Schwartz JR, Modafinil in the Treatment of Excessive Sleepiness, Drug Des Devel Ther, 2009, 2:71-85. [PubMed 19920895]

17. Stankoff B, Waubant E, Confavreux C, et al French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology.200564(7):1139-1143. [PubMed 15824337]

18. Taylor FB and Russo J, Efficacy of Modafinil Compared to Dextroamphetamine for the Treatment of Attention Deficit Hyperactivity Disorder in Adults, J Child AdolescPsyc hopharmacol, 2000, 10(4):311-20. [PubMed 11191692]

19. U.S. 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. [PubMed 9450772]

20. Vetter VL, Elia J, Erickson CH, et al American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee American HeartAssoci ation Council on Cardiovascular Nursing. Cardiovascular monitoring of chil dren and adolescents with heart disease receiving m edications for attentiondeficit/hyperactivity disorder [corrected]: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital CardiacDefects Committee and the Council on Cardiovascular Nursing. Circulation. 2008117(18):2407-2423. [PubMed18427125]

21. Wong, YN, Single-Dose Pharmacokinetics of Modafinil and Methylphenidate Given Alone or in Combination in Healthy Male Volunteers, J Clin Pharmacol, 1998,38(3):276-282. [PubMed 9549666]

Topic 10157 Version 138.0
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