Modafinil

DEA Class; Rx

Common Brand Names; Provigil

Distinct CNS stimulant; not related to amphetamines; increases mental alertness and decreases fatigue
In adults, used for narcolepsy and to reduce fatigue or excessive daytime sleepiness associated with sleep apnea or circadian rhythm disruptions, such as shift-work disorder
Safety and efficacy not established for pediatric use for any indication

Indicated for the treatment of narcolepsy to improve wakefulness in patients with excessive sleepiness.

Hypersensitivity

• Headache (45-50%)
• Rhinitis (11-15%)
• Decreased appetite (16%)
• Nausea (11%)
• Abdominal pain (12%)
• Nervousness (6-10%)
• Syncope (1-5%)
• Arrhythmia
• Hypotension
• Hypertension
• T-wave changes
• Amnesia
• Anxiety
• Cataplexy
• Chills
• Depression
• Dizziness
• Epistaxis
• Fever
• Insomnia
• Paresthesia
• Reversible psychosis (rare)
• Tremor
• Drug hypersensitivity syndrome
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis due to drug
• Anorexia
• Diarrhea
• Dry mouth
• Mouth ulcer
• Vomiting
• Abnormal LFT
• Chest pain
• Neck pain
• Dyspnea
• Pharyngitis
• Aggression
• Psychomotor hyperactivity

Risk of skin reactions (eg SJS, toxic necrolysis, and drug rash with eosinophilia and systemic symptoms); discontinue if rash or other hypersensitivity reactions occur

May impair ability to operate heavy machinery and perform hazardous tasks

Not recommended in patients with angina, cardiac ischemia, recent history of myocardial infarction, left ventricular hypertrophy, or mitral valve prolapse

Use with caution in severe hepatic impairment, elderly, history of: depression, psychosis (may exacerbate psychiatric symptoms), or mania

Use with caution in patients with Tourette syndrome; stimulants may unmask ticks

May reduce effectiveness of steroidal contraceptives 1 month after discontinuation of drug therapy

Reassess degree of sleepiness frequently; if used adjunctively with continuous positive airway pressure (CPAP): Periodic assessment of CPAP compliance is necessary

Discontinue at first sign of serious rash

Discontinue therapy if symptoms suggest angioedema or anaphylaxis

Discontinue if multiorgan hypersensitivity reaction is suspected

Well controlled studies in pregnant women have not been performed

Intrauterine growth restriction and spontaneous abortion have been reported with modafinil and armodafinil

In studies conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures

Unknown is excreted in human milk