Side Effects > Nuvigil

Nuvigil Side Effects

Generic Name: armodafinil

Please note - some side effects for Nuvigil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nuvigil - for the Consumer

Nuvigil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nuvigil:

Diarrhea; dizziness; dry mouth; headache; nausea; stomach pain or upset; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Nuvigil:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever or sore throat; increased urination; mental or mood changes (eg, agitation, anxiety, depression, exaggerated sense of well-being, hallucinations, irritability, nervousness); mouth sores; red, swollen, blistered, or peeling skin; shortness of breath; suicidal thoughts or actions; unusual bruising or bleeding; vomiting; weakness; yellowing of the skin or eyes.

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Nuvigil Side Effects - for the Professional

Nuvigil

Armodafinil has 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 Nuvigil 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 following table (Table 3) presents the adverse experiences that occurred at a rate of 1% or more and were more frequent in patients treated with Nuvigil than in placebo group patients in the placebo-controlled clinical 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.

Table 3. Incidence > 1% (In Percent) Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trialsª In OSAHS, Narcolepsy and SWSD With Nuvigil (150 mg and 250 mg)

System Organ Class      MedDRA preferred term		Nuvigil (Percent, N = 645)	Placebo (Percent, N = 445)
ª Four double-blind, placebo-controlled clinical studies in SWSD, OSAHS, and narcolepsy; incidence is rounded to the nearest whole percent. Included are only those events for which Nuvigil incidence is greater than that of placebo.
Cardiac Disorders
	Palpitations	2	1
Gastrointestinal Disorders
	Nausea	7	3
	Diarrhea	4	2
	Dry Mouth	4	1
	Dyspepsia	2	0
	Abdominal Pain Upper	2	1
	Constipation	1	0
	Vomiting	1	0
	Loose Stools	1	0
General Disorders And Administration Site Conditions
	Fatigue	2	1
	Thirst	1	0
	Influenza-Like Illness	1	0
	Pain	1	0
	Pyrexia	1	0
Immune System Disorders
	Seasonal Allergy	1	0
Investigations
	Gamma-Glutamyltransferase Increased	1	0
	Heart Rate Increased	1	0
Metabolism And Nutrition Disorders
	Anorexia	1	0
	Decreased Appetite	1	0
Nervous System Disorders
	Headache	17	9
	Dizziness	5	2
	Disturbance In Attention	1	0
	Tremor	1	0
	Migraine	1	0
	Paraesthia	1	0
Psychiatric Disorders
	Insomnia	5	1
	Anxiety	4	1
	Depression	2	0
	Agitation	1	0
	Nervousness	1	0
	Depressed Mood	1	0
Renal And Urinary Disorders
	Polyuria	1	0
Respiratory, Thoracic And Mediastinal Disorders
	Dyspnea	1	0
Skin And Subcutaneous Tissue Disorders
	Rash	2	0
	Contact Dermatitis	1	0
	Hyperhydrosis	1	0

Dose Dependency of Adverse Events

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

Table 4. Incidence (In Percent) Of Dose-Dependent, Treatment-Emergent Adverse Experiences By Dose and By Treatment In Parallel-Group, Placebo-Controlled Clinical Trialsª In OSAHS, Narcolepsy and SWSD With Nuvigil (150 mg and 250 mg)

ª Four double-blind, placebo-controlled clinical studies in SWSD, OSAHS, and narcolepsy.
System Organ Class        MedDRA preferred term		Nuvigil 250 mg (Percent, N=198)	Nuvigil 150 mg (Percent, N=447)	Nuvigil Combined (Percent, N=645)	Placebo (Percent, N=445)
Gastrointestinal Disorders
	Nausea	9	6	7	3
	Dry Mouth	7	2	4	<1
Nervous System Disorders
	Headache	23	14	17	9
Psychiatric Disorders
	Insomnia	6	4	5	1
	Depression	3	1	2	<1
Skin And Subcutaneous Tissue Disorders
	Rash	4	1	2	<1

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 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 administration in placebo-controlled clinical trials.

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Side Effects by Body System

General

In general, armodafinil has been well tolerated and most side effects have been mild to moderate in severity.

Cardiovascular

Cardiovascular side effects have included palpitations (2%) and tachycardia (1%).

Gastrointestinal

Gastrointestinal side effects have frequently included nausea (7%), diarrhea (4%), dry mouth (4%), dyspepsia (2%), and upper abdominal pain (2%). Constipation, vomiting, anorexia, decreased appetite, and loose stools have been reported in 1% of patients.

Nervous system

Nervous system side effects have included headache (17%), dizziness (5%), insomnia (5%), tremor (1%), migraine headache (1%), paresthesia (1%), and disturbance in attention (1%).

Other

Other side effects have included fatigue (2%), thirst (1%), influenza-like illness (1%), fever (1%), and pain (1%).

Psychiatric

Psychiatric side effects have included anxiety (4%), depression (2%), agitation (1%), nervousness (1%), and depressed mood (1%).

Genitourinary

Genitourinary side effects have included polyuria (1%).

Respiratory

Respiratory side effects have included dyspnea (1%).

Dermatologic

Dermatologic side effects have included rash (2%), contact dermatitis (1%), and hyperhydrosis (1%).

Hematologic

Hematologic side effects include a single case of mild pancytopenia that resolved following discontinuation of armodafinil.

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