MODAFINIL

MODAFINIL
(mod-a'fi-nil)
Provigil, Alertec 
Armodafinil
Nuvigil
Classifications: cns stimulant, analeptic;
Therapeutic:cns stimulant

Pregnancy Category: C
Controlled Substance: Schedule IV

Availability

100 mg, 200 mg capsules; 50 mg, 150 mg, 200 mg tablets

Action

Primary sites of CNS stimulant activity of modafinil appear to be in the hippocampus, the centrolateral nucleus of the thalamus, and the central nucleus of the amygdala. Limited animal studies demonstrate that modafinil may increase excitatory glutaminergic transmission in the thalamus and hippocampus.

Therapeutic Effect

Modafinil causes wakefulness, increased locomotor activity, and psychoactive and euphoric effects.

Uses

Improve wakefulness in patients with narcolepsy or excessive sleepiness associated with shift work sleep disorder, obstructive sleep apnea/hypopnea syndrome.

Unlabeled Uses

Fatigue related to organic brain syndrome or multiple sclerosis.

Contraindications

Hypersensitivity to modafinil; acute MI, valvular heart disease; pregnancy (category C); lactation. Safety and efficacy in children <16 y are unknown.

Cautious Use

Cardiovascular disease including left ventricular hypertrophy; cardiac disease, ischemic ECG changes, chest pain, arrhythmias, mitral valve prolapse, recent MI, unstable angina; older adults; history of drug or alcohol abuse; psychosis or emotional instability; leukopenia, MI, neurological disease, hypertension, severe hepatic disease, severe renal impairment, renal failure, seizure disorder, sleep apnea.

Route & Dosage

Narcolepsy, Fatigue
Adult: PO (Provigil) 200 mg/d as single dose in the morning; (Nuvigil) 150–250 mg q a.m.

Shift-Work Sleep Disorder
Adult: PO (Nuvigil) 150 mg 1 h prior to shift

Hepatic Impairment
Reduce dose by 50%.

Administration

Oral
  • Give in the morning shortly after awakening.
  • Store at 15°–30° C (59°–86° F).

Adverse Effects (≥1%)

Body as a Whole: Chest pain, neck pain, chills, eosinophilia. CNS: Headache, nervousness, dizziness, depression, anxiety, cataplexy, insomnia, paresthesia, dyskinesia, hypertonia. CV: Hypotension, hypertension, vasodilation, arrhythmia, syncope. GI: Nausea, diarrhea, dry mouth, anorexia, abnormal LFTs, vomiting, mouth ulcer, gingivitis, thirst. Respiratory: Rhinitis, pharyngitis, lung disorder, dyspnea. Skin: Dry skin. Special Senses: Amblyopia, abnormal vision.

Interactions

Drug: Methylphenidate may delay absorption of modafinil; modafinil may decrease levels of cyclosporine, oral contraceptives; modafinil may increase levels of clomipramine, phenytoin, warfarin, tricyclic antidepressants.

Pharmacokinetics

Absorption: Rapidly absorbed. Peak: 2–4 h. Distribution: Approximately 60% protein bound. Metabolism: In liver to inactive metabolites. Elimination: In urine. Half-Life: 15 h.

Nursing Implications

Assessment & Drug Effects

  • Therapeutic effectiveness: Indicated by improved daytime wakefulness.
  • Monitor BP and cardiovascular status, especially with preexisting hypertension and mitral valve prolapse or other CV condition.
  • Monitor for S&S of psychosis, especially when history of psychotic episodes exists.
  • Lab tests: Periodic liver function tests.
  • Coadministered drugs: Monitor INR with warfarin for first several months and when dosage is changed; monitor for toxicity with phenytoin.

Patient & Family Education

  • Use barrier contraceptive instead of/in addition to hormonal contraceptive.
  • Inform physician of all prescription or OTC drugs in/added to your regimen.
  • Notify physician if any S&S of an allergic reaction appear.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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