mo-DAF-i-nil

Therapeutic Classification: central nervous system stimulants

• Excessive daytime drowsiness due to narcolepsy, obstructive sleep apnea, or shift work sleep disorder.

• Produces CNS stimulation.

• Decreased daytime drowsiness in patients with narcolepsy and obstructive sleep apnea.
• Decreased drowsiness during work in patients with shift work sleep disorder.

Absorption: Rapidly absorbed; bioavailability unknown.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Highly (90%) metabolized by the liver; <10% eliminated unchanged in the urine.

Half-life: 15 hr.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity
• History of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia, or other significant manifestations of mitral valve prolapse in association with CNS stimulant use
• OB: Pregnancy.

Use Cautiously in:

• History of MI or unstable angina
• Severe hepatic impairment with or without cirrhosis (dosage ↓ recommended)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children
• Geri: Lower doses may be necessary in older adults due to ↑ sensitivity to drug effects.

CV: arrhythmias, chest pain, hypertension, hypotension, syncope.

Derm: dry skin, rash, STEVENS-JOHNSON SYNDROME (SJS).

EENT: rhinitis, abnormal vision, amblyopia, epistaxis, pharyngitis.

Endo: hyperglycemia.

F and E: ↑thirst.

GI: ↑liver enzymes, nausea, anorexia, diarrhea, gingivitis, mouth ulcers, vomiting.

GU: abnormal ejaculation, albuminuria, urinary retention.

Hemat: eosinophilia.

MS: joint disorder, neck pain.

Neuro: headache, aggression, amnesia, anxiety, ataxia, cataplexy, confusion, delusions, depression, dizziness, dyskinesia, hallucinations, hypertonia, insomnia, mania, paresthesia, SEIZURES, SUICIDAL IDEATION, tremor.

Resp: dyspnea.
Misc: (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)HYPERSENSITIVITY REACTIONS , infection.

Drug-Drug:

• May ↓ the metabolism and ↑ the effects of diazepam, phenytoin, propranolol, or tricyclic antidepressants; dosage adjustments may be necessary.
• May ↑ the metabolism and ↓ the effects of hormonal contraceptives, cyclosporine, and theophylline; dosage adjustments or additional methods of contraception may be necessary.

Drug-Natural Products:

• Use with caffeine-containing herbs (cola nut, guarana, mate, tea, coffee) may ↑ stimulant effect.

• PO (Adults): 200 mg once daily.

(Generic available)

• Tablets: 100 mg; 200 mg;

• Observe and document frequency of narcoleptic episodes.
• Monitor closely for changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
• Assess for rash periodically during therapy. May cause SJS. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
• Monitor for signs and symptoms of angioedema or anaphylaxis (rash, swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).

• May cause elevated liver enzymes.

• PO: Administer as a single dose in the morning for patients with narcolepsy or obstructive sleep apnea. Administer 1 hr before the start of work shift for patients with shift work sleep disorder.

• Instruct patient to take medication as directed. Advise patient to read the Medication Guide prior to starting therapy and with each Rx refill, in case of changes.
• Medication may impair judgment. Advise patient to use caution when driving or during other activities requiring alertness.
• Advise patient that modafinil is a drug with known abuse potential. Advise patient that sharing this medication with others, even those with the same symptoms, is dangerous and illegal. Protect it from theft; store out of sight and reach of children, and in a location not accessible by others.
• Encourage patient and family to be alert for emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression and suicidal ideation, especially during early antidepressant therapy. Assess symptoms on a day-to-day basis as changes may be abrupt. If these symptoms occur, notify health care professional.
• Advise patient to notify health care professional immediately if rash or symptoms of anaphylaxis occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. If alcohol is used during therapy, intake should be limited to moderate amounts.
• Advise females of reproductive potential to use effective nonhormonal methods of contraception during and for 1 mo following discontinuation of therapy. Instruct patient to notify health care professional promptly if pregnancy is planned or suspected, or if breastfeeding. Encourage women who become pregnant to enroll in the registry by calling 1-866-404-4106. Registry collects information about the safety of modafinil during pregnancy.

• Decrease in narcoleptic symptoms and an enhanced ability to stay awake.

Provigil

Alertec

Schedule IV (C-IV)