Nuvigil (Armodafinil) Side Effects

Nuvigil is a stimulant drug approved in the United States since June 1, 2009. The generic ingredient of Nuvigil is armodafinil, the purified R-enantiomer of modafinil (brand name Provigil). Information about armodafinil mainly comes from studies of modafinil. Armodafinil has a longer half-life in the body that the other enantiomer, S-modafinil, so it is thought to be likely to be more effective than racemic modafinil, but this has not been proven yet in clinical studies. The commonly prescribed dosage is 150 mg or 250 mg.

Armodafinil is in Pregnancy Category C, and it is unknown whether it passes into breast milk.

Clinical testing on about 1100 patients has shown armodafinil to be relatively safe for adults for the duration of the study periods. It causes slight but consistent increases in heart rate and blood pressure (both diastolic and systolic). Because it is a new medication, the long-term safety of armodafinil has not been studied.

Modafinil is considered a safer medication (i.e. it has less severe side effects) than traditional psychostimulant drugs, including methylphenidate (Ritalin) and amphetamines (Adderall) (Banerjeeac et al. 2004). This safer side effect profile is assumed to apply to armodafinil as well. Armodafinil is considered to have potential for abuse, but this potential is much lower than for other psychostimulants.

The most common side effects of Nuvigil are mild to moderate and usually do not cause the patient to discontinue the medication.

In four placebo-controlled trials, the most common side effects include the following. Percentages are given as the percentage of placebo patients reporting that symptom subtracted from the percentage of armodafinil patients reporting that symptom.

Headache 8% (= 17% for armodafinil patients - 9% for placebo patients)

Nausea 4% (= 7% - 3%)

Insomnia 4% ( = 5% - 1%)

Dizziness 3% (= 5% - 2%)

Anxiety 3% (= 4% - 1%)

Dry mouth 3% (= 4% - 1%)

Most Nuvigil side effects are not dose-dependent. The only dosage-related side effects were headache, rash, depression (rare), dry mouth, insomnia, and nausea.

Up to 4% (at the highest dosage, 250 mg) of patients taking armodafinil reported a skin rash. The incidence of skin rashes was much less (1%) at the lower dosage, 150 mg. More rare dermatological side effects include contact dermatitis and excessive sweating.

Modafinil and armodafinil are associated with the rare occurrence of severe, life-threatening skin conditions or rashes. These conditions include toxic epidermal necrolysis, drug hypersensitivity syndrome (also called DRESS), and Stevens-Johnson syndrome. These conditions, which may be preceded by fever, may occur between 1 and 10 weeks after starting the medication. They are more common in children, and for that reason armodafinil is not approved for use in patients age 17 and under.

FDA label for armodafinil (NUVIGIL).

"Modafinil (marketed as Provigil): Serious Skin Reactions." Postmarketing Reviews (FDA publication) Volume 1, Number 1, Fall 2007.

Dev Banerjeeac et al. "Pharmacotherapy for excessive daytime sleepiness." Sleep Medicine Reviews October 2004, 8(5):339-354.