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Provigil (Modafinil) has been evaluated for safety in over 3500 patients, of whom more than 2000 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness were given at least one dose of modafinil. In clinical trials, modafinil has been found to be generally well tolerated and most adverse experiences were mild to moderate.

The most commonly observed adverse events (.5%) associated with the use of Modafinil (Provigil) tablets more frequently than placebo-treated patients in the placebo-controlled clinical studies in primary disorders of sleep and wakefulness were nausea, headache, nervousness, diarrhea, rhinitis, back pain, insomnia, anxiety, dizziness, and dyspepsia. The adverse event profile was similar across these studies.

In the placebo-controlled clinical trials, 74 of the 934 patients (8%) who received Provigil (Modafinil) discontinued due to an adverse experience compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for Modafinil (Provigil) than placebo patients were headache (2%), anxiety, nausea, dizziness, insomnia, chest pain and nervousness (each < 1%). In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses).

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 Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trials1 With PROVIGIL In Adults With Narcolepsy, OSA, and SWD (200 mg, 300 mg and 400 mg)

Body as a whole: headache, back pain, flu syndrome, chest pain, chills, neck rigidity

Cardiovascular: hypertension, tachycardia, palpitation, vasodilatation

Digestive: nausea, diarrhea, dyspepsia, dry mouth, anorexia, constipation, abnormal liver function, flatulence, mouth ulceration, thirst

Hemic / Lymphatic: eosinophilia

Metabolic / Nutritional: edema

Nervous: Nervousness, insomnia, anxiety, dizziness, depression, paresthesia, somnolence, hypertonia, dyskinesia, hyperkinesia, agitation, confusion, tremor, emotional lability, vertigo

Respiratory: rhinitis, pharyngitis, lung disorder, epistaxis, asthma

Skin / Appendages: sweating, herpes simplex

Special senses: amblyopia, abnormal vision, taste perversion, eye pain

Urogenital: urine abnormality hematuria pyuria

Dose Dependency of Adverse Events

In the adult placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of Provigil (Modafinil) and placebo, the only adverse events that were clearly dose related were headache and anxiety.

Vital Sign Changes

While there was no consistent change in mean values of heart rate or systolic and diastolic blood pressure, the requirement for antihypertensive medication was slightly greater in patients on Modafinil (Provigil) compared to placebo.

Weight Changes

There were no clinically significant differences in body weight change in patients treated with Provigil (Modafinil) tablets compared to placebo-treated patients in the placebo-controlled clinical trials.

Laboratory Changes

Clinical chemistry, hematology, and urinalysis parameters were monitored in Phase 1, 2, and 3 studies. In these studies, mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of Modafinil (Provigil) tablets, but not placebo. Few subjects, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with Provigil (Modafinil) in the Phase 3 clinical trials. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin.

ECG Changes

No treatment-emergent pattern of ECG abnormalities was found in placebo-controlled clinical trials following administration of Provigil (Modafinil) tablets.

Postmarketing Reports

The following adverse reactions have been identified during post-approval use of Modafinil (Provigil) tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: seriousness of the reaction, frequency of the reporting, or strength of causal connection to Provigil (Modafinil).

Hematologic: agranulocytosis

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