Modafinil

(moe-DAFF-ih-nill)

Provigil

Tablets: 100 mg, 200 mg

Class: CNS stimulant/Analeptic

 Action Wakefulness-promoting agent; however, precise mechanism(s) unknown.

 Indications Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

 Contraindications Standard considerations.

 Route/Dosage

ADULTS AND CHILDREN 16 YR AND OLDER: PO 200 mg/day as a single morning dose. Hepatic impairment: A dose reduction of 50% is recommended.

 Interactions

Clomipramine: Plasma levels may be increased by modafinil. Cyclosporine: Blood levels may be decreased by modafinil. MAO inhibitors (eg, isocarboxazid): Use with caution. Methylphenidate: May delay the absorption of modafinil. Oral contraceptives: Efficacy may be decreased by modafinil, increasing the risk of unintended pregnancy. Phenytoin: Increased risk of phenytoin toxicity. Tricyclic antidepressants (certain TCAs [eg, clomipramine, desipramine]): Plasma levels of certain TCAs may be increased. Warfarin: Monitor prothrombin times.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypotension; hypertension; vasodilation; arrhythmia; syncope. CNS: Headache; nervousness; dizziness; depression; anxiety; cataplexy; insomnia; dyskinesia; confusion; amnesia; emotional lability. DERM: Herpes simplex; dry skin. EENT: Rhinitis; pharyngitis; amblyopia; abnormal vision. GI: Nausea; diarrhea; dry mouth; anorexia; vomiting; mouth ulcer; gingivitis; thirst. GU: Abnormal urine; urinary retention; abnormal ejaculation. HEPA: Abnormal liver function. META: Hyperglycemia; albuminuria. RESP: Lung disorder; dyspnea; asthma; epistaxis. OTHER: Paresthesia; hypertonia; ataxia; tremor; chest pain; neck pain; chills; rigid neck; fever and chills; joint disorder.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy in children less than 16 yr not established. Drug dependence: Because of psychoactive and euphoric effects, modafinil has potential for abuse. Hepatic impairment: Dosage reduction is recommended in patients with severe hepatic impairment.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Administer prescribed dose once daily.
• Administer dose in morning to minimize sleep disturbances.
• Administer without regard to food.
• Store at controlled room temperature (68° to 77°F).

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of the following: significant manifestations of mitral valve prolapse (eg, chest pain, palpitations, dyspnea, ischemic ECG changes) with previous CNS stimulant use; recent MI; unstable angina; liver disease; psychosis; drug or stimulant abuse.
• Monitor patient for response to therapy.
• Administer reduced dose to patient with severe hepatic impairment.
• Monitor blood pressure periodically in patient with history of hypertension.
• Monitor patient for CNS, CV, GI, and general body side effects. Report to health care provider if noted and significant.

OVERDOSAGE: SIGNS & SYMPTOMS   Excitation, agitation, insomnia, slight to moderate elevations in hemodynamic parameters, anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, decreased prothrombin time

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take prescribed dose once daily. Advise patient to take dose in the morning to minimize sleep disturbances.
• Advise patient that medication should be taken as prescribed and to not stop taking or to change the dose unless advised to by the health care provider.
• Caution patient that medication may impair ability to drive or perform other tasks requiring mental alertness and to use caution until effect of medication has been determined.
• Advise patient or caregiver to notify health care provider if appetite loss, nervousness, or difficulty sleeping occur and are bothersome.
• Advise patient to notify health care provider if rash, hives, or other symptoms of an allergic reaction occur, or if any unusual or unexplained symptoms are noted.
• Advise women using hormonal contraception (eg, oral, depot, implantable) to use alternative or concomitant methods of contraception with and for 1 mo following discontinuation of therapy.
• Advise women to inform the health care provider if becoming pregnant, planning on becoming pregnant, or breastfeeding.
• Warn patient to not take any prescription or OTC drugs or dietary supplements without consulting health care provider.
• Advise patient or caregiver that follow-up visits and lab tests may be necessary to monitor therapy and to be sure to keep appointments.

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