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Nuvigil (Armodafinil) tablets have been evaluated for safety in over 1100 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness. In clinical trials, Nuvigil has been found to be generally well tolerated and most adverse experiences were mild to moderate.

In the placebo-controlled clinical studies, the most commonly observed adverse events ( >= 5%) associated with the use of Armodafinil (Nuvigil) tablets occurring more frequently than in the placebo-treated patients were headache, nausea, dizziness, and insomnia. The adverse event profile was similar across the studies.

In the placebo-controlled clinical trials, 44 of the 645 patients (7%) who received Nuvigil discontinued due to an adverse experience compared to 16 of the 445 (4%) of patients that received placebo. The most frequent reason for discontinuation was headache (1%).

Incidence in Controlled Trials

The prescriber should be aware that the figures provided below cannot be used to predict the frequency of adverse experiences in the course of usual medical practice, where patient characteristics and other factors may differ from those occurring during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. Review of these frequencies, however, provides prescribers with a basis to estimate the relative contribution of drug and non-drug factors to the incidence of adverse events in the population studied.

Incidence > 1% of treatment-emergent adverse experiences in parallel-group, placebo-controlled clinical trialsa in OSA, narcolepsy and SWD with Nuvigil 150 mg and 250 mg

Cardiac Disorders: palpitations

Gastrointestinal Disorders: diarrhea, nausea, vomiting, dry mouth, abdominal pain upper, dyspepsia, constipation, loose stools

General Disorders And Administration Site Conditions: thirst, fatigue, influenza-like illness, pain, pyrexia

Immune System Disorders: seasonal allergy

Investigations: gamma-glutamyltransferase increased, heart rate increased

Metabolism And Nutrition Disorders: anorexia, decreased appetite

Nervous System Disorders: dizziness, headache, disturbance in attention, migraine, tremor, paresthesia

Psychiatric Disorders: anxiety, depression, insomnia, agitation, depressed mood, nervousness

Renal And Urinary Disorders: polyuria

Respiratory, Thoracic And Mediastinal Disorders: dyspnea

Skin And Subcutaneous Tissue Disorders: contact dermatitis, rash, hyperhydrosis

Dose Dependency of Adverse Events

In the placebo-controlled clinical trials which compared doses of 150 mg/day and 250 mg/day of Nuvigil (Armodafinil) and placebo, the only adverse events that appeared to be dose-related were headache, rash, depression, dry mouth, insomnia, and nausea.

Incidence (in percent) of dose-dependent, treatment-emergent adverse experiences by dose and by treatment in parallel-group, placebo-controlled clinical trialsa in OSA, narcolepsy and SWD with Nuvigil 150 mg and 250 mg

Gastrointestinal Disorders: nausea, dry mouth

Nervous System Disorders: headache

Psychiatric Disorders: insomnia, depression

Skin And Subcutaneous Tissue Disorders: rash

Vital Sign Changes

There were small, but consistent, increases in average values for mean systolic and diastolic blood pressure in controlled trials. There was a small, but consistent, average increase in pulse rate over placebo in controlled trials. This increase varied from 0.9 to 3.5 BPM.

Laboratory Changes

Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of Armodafinil (Nuvigil), but not placebo. Few subjects, however, had GGT or AP elevations outside of the normal range. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin, although there were rare cases of isolated elevations of AST and/or ALT. A single case of mild pancytopenia was observed after 35-days of treatment and resolved with drug discontinuation. A small mean decrease from baseline in serum uric acid compared to placebo was seen in clinical trials. The clinical significance of this finding is unknown.

ECG Changes

No pattern of ECG abnormalities could be attributed to Nuvigil (Armodafinil) tablets administration in placebo-controlled clinical trials.

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