Modafinil

A to Z Drug Facts

Modafinil

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(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.