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Nuvigil (Armodafinil) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Trials™ 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)

™ 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 Trials™ In OSAHS, Narcolepsy and SWSD With NUVIGIL (150 mg and 250 mg)

™ 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 (See PRECAUTIONS). 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.



REPORTS OF SUSPECTED NUVIGIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nuvigil. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nuvigil side effects / adverse reactions in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 65 year old female weighing 79.4 kg (174.6 pounds)

Reactions: Blood Bilirubin Increased, Weight Decreased, Wrong Technique in Drug Usage Process, Pruritus, Treatment Noncompliance, Transaminases Increased, Stomatitis, Dysphagia, Blood Urine Present, Tablet Physical Issue, Anaemia, Poor Quality Drug Administered, Vulvovaginal Pain, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Haemorrhoidal Haemorrhage, Photophobia, Sinusitis, Nausea, Haemorrhoids, Underdose, Eye Pain, Blood Glucose Decreased, Dysgeusia, Product Packaging Issue, Disease Recurrence, Hypophagia, Alopecia, Dysuria, Feeling Abnormal, DRY Eye, Asthenia, Leukopenia

Suspect drug(s):
Cozaar
    Dosage: 50 mg daily
    Indication: Hypertension

Aspirin
    Dosage: 81 mg daily, oral
    Administration route: Oral

Peginterferon Alfa-2A
    Dosage: 180 microgram/0.5 ml,1 each friday night ; 180 microgram/ml weekly, subcutaneous
    Indication: Hepatitis C
    Start date: 2005-09-01
    End date: 2006-02-01

Peginterferon Alfa-2A
    Dosage: 180 microgram/0.5 ml,1 each friday night ; 180 microgram/ml weekly, subcutaneous
    Indication: Hepatitis C
    Start date: 2011-07-29

Victrelis
    Dosage: 200 mg (four thrice daily),oral
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-08-26

Pradaxa
    Dosage: 150 mg am and pm, oral ; 75mg daily, oral
    Administration route: Oral
    Indication: Anticoagulant Therapy

Toprol-XL
    Dosage: 50 mg once daily,oral ; 25mg daily, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01

Acetaminophen

Nuvigil
    Dosage: 50mg daily, oral
    Administration route: Oral

Ribavirin
    Dosage: 600 mg, one in am and pm ; 600mg am and 400mg pm, oral
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-09-23

Ribavirin
    Dosage: 600 mg, one in am and pm ; 600mg am and 400mg pm, oral
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2005-09-01
    End date: 2006-02-01

Ribavirin
    Dosage: 600 mg, one in am and pm ; 600mg am and 400mg pm, oral
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-29

Zofran
    Dosage: 8 mg (one every 12 hrs as needed), oral
    Administration route: Oral
    Indication: Nausea
    Start date: 2011-08-26

Rythmol SR (Propaphenone Hcl)
    Dosage: 325 mg (am and pm each),oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2008-01-01

Other drugs received by patient: Calcium Carbonate; Metoclopramide Hydrochloride; Fish OIL with Omega3 Fatty Acids; Multi-Vitamins; Calcium Plus Vitamin D; Reglan



Possible Nuvigil side effects / adverse reactions in 54 year old male

Reported by a physician from United States on 2011-10-12

Patient: 54 year old male

Reactions: Photosensitivity Reaction, Chest Discomfort, Dyspnoea

Suspect drug(s):
Nuvigil



Possible Nuvigil side effects / adverse reactions in 65 year old male

Reported by a physician from United States on 2011-10-13

Patient: 65 year old male

Reactions: Stomatitis, Exfoliative Rash, Rash Erythematous, Bruxism, Rash Maculo-Papular

Suspect drug(s):
Nuvigil
    Administration route: Oral
    Indication: Hypersomnia
    Start date: 2011-10-04
    End date: 2011-10-07

Nuvigil
    Administration route: Oral
    Indication: Sleep Apnoea Syndrome
    Start date: 2011-10-03
    End date: 2011-10-03



See index of all Nuvigil side effect reports >>

Drug label data at the top of this Page last updated: 2009-07-06

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