Modafinil adverse effects

MODAFINIL 1. ANTIBIOTICS-clarithromycin, telithromycin 2. ANTIFUNGALS-itraconazole, ketoconazole 3. ANTIVIRALS-indinavir, nelfinavir, ritonavir, saquinavir t plasma concentrations of modafinil, with risk of adverse effects Due to inhibition of CYP3A4, which has a partial role in the metabolism of modafinil Be aware. Warn patients to report dose-related adverse effects, e.g. headache, anxiety... 

In a 9-week, single-blind, placebo-controlled pilot study in 72 patients with multiple sclerosis who took modafinil 200 mg/day for 2 weeks, there was significant improvement in fatigue compared with placebo run-in treatment (8). The most frequent adverse effects were headache, nausea, and anxiety, and these were rated as either mild or moderate. 

In patients with primary biliary cirrhosis the dosage of modafinil was limited to 200 mg/day because of the possibility of reduced drug metabolism in this population [80 ]. Despite the low dosage, some patients had adverse effects, including nausea, insomnia, headache, and nervousness. 

A 25-year-old woman with a history of narcolepsy took modafinil, titrated up to 300 mg/ day, and had dry mouth and tachycardia. After 5 days, she continued to take 300 mg/ day without any apparent adverse effects. About 6 months later she had visual and auditory hallucinations and delusions of reference. Modafinil was withdrawn and her psychotic symptoms resolved. After restarting modafinil on alternate days occasional hallucinations recurred. 

In an open, randomized, crossover study in healthy men, concomitant administration of single oral doses of modafinil (200 mg) and dexamfetamine (10 mg), each given separately, produced a slight increase in blood pressure and the cardiovascular effects were more pronounced after concomitant administration (3). These changes were considered not to be clinically relevant and would not necessarily preclude shortterm administration of the two drugs together. The most frequent adverse events with modafinil or dexamfetamine were headache, dizziness, insomnia, and dry mouth. 

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