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Provigil

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Provigil

Provigil Side Effects Center

Pharmacy Editor: Eni Williams, Pharm.D., Ph.D.

Provigil (modafinil) is a medication that belongs to the drug class called stimulants. Provigil is prescribed to increase wakefulness in patients with excessive sleepiness related to narcolepsy, shiftwork sleep disorder, and obstructive sleep apnea/hypopnea syndrome. Common side effects of Provigil are headache, upper respiratory tract infection, nausea, nervousness, anxiety, and insomnia.

Provigil dosage is 200 or 400 mg daily. Provigil drug interactions include cyclosporine (Sandimmune), theophylline (Theo-24), hormonal contraceptives (for example, Micronor), warfarin (Coumadin), diazepam (Valium), propranolol (Inderal), imipramine (Tofranil), desipramine (Norpramin), phenytoin (Dilantin), carbamazepine (Tegretol), rifampin (Rifadin), Ketoconazole (Nizoral) and itraconazole (Sporanox). Provigil has not been adequately studied in pregnant women and it is unknown if it is excreted in breast milk.

Our Provigil Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Provigil in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using modafinil and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • white patches or sores inside your mouth or on your lips;
  • hallucinations, unusual thoughts or behavior;
  • depression, anxiety, aggression; or
  • chest pain, uneven heart beats.

Less serious side effects may include:

  • headache, dizziness;
  • feeling nervous or agitated;
  • nausea, diarrhea;
  • trouble sleeping (insomnia); or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Provigil (Modafinil) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Provigil Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, nervousness, anxiety, dizziness, and difficulty sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: mental/mood changes (e.g., agitation, confusion, depression, abnormal thoughts, hallucinations).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/pounding/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, stop taking this medication and seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), skin blisters/peeling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Provigil (Modafinil)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Provigil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 PROVIGIL (modafinil) more frequently than placebo-treated patients in the placebo-controlled clinical studies in primary disorders of sleep and wakefulness were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, 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 PROVIGIL (modafinil) than placebo patients were headache (2%), nausea, anxiety, 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 following table (Table 3) presents the adverse experiences that occurred at a rate of 1% or more and were more frequent in adult patients treated with PROVIGIL (modafinil) than in placebo-treated patients in the principal, 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 Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trials1 With PROVIGIL (modafinil) In Adults With Narcolepsy, OSA, and SWD (200mg, 300mg and 400mg)*

Body System Preferred Term Modafinil
(n = 934)
Placebo
(n = 567)
Body as a Whole Headache 34% 23%
Back Pain 6% 5%
Flu Syndrome 4% 3%
Chest Pain 3% 1%
Chills 1% 0%
Neck Rigidity 1% 0%
Cardiovascular Hypertension 3% 1%
Tachycardia 2% 1%
Palpitation 2% 1%
Vasodilatation 2% 0%
Digestive Nausea 11% 3%
Diarrhea 6% 5%
Dyspepsia 5% 4%
Dry Mouth 4% 2%
Anorexia 4% 1%
Constipation 2% 1%
Abnormal Liver Function2 2% 1%
Flatulence 1% 0%
Mouth Ulceration 1% 0%
Thirst 1% 0%
Hemic/Lymphatic Eosinophilia 1% 0%
Metabolic/Nutritional Edema 1% 0%
Nervous Nervousness 7% 3%
Insomnia 5% 1%
Anxiety 5% 1%
Dizziness 5% 4%
Depression 2% 1%
Paresthesia 2% 0%
Somnolence 2% 1%
Hypertonia 1% 0%
Dyskinesia3 1% 0%
Hyperkinesia 1% 0%
Agitation 1% 0%
Confusion 1% 0%
Tremor 1% 0%
Emotional Lability 1% 0%
Vertigo 1% 0%
Respiratory Rhinitis 7% 6%
Pharyngitis 4% 2%
Lung Disorder 2% 1%
Epistaxis 1% 0%
Asthma 1% 0%
Skin/Appendages Sweating 1% 0%
Herpes Simplex 1% 0%
Special Senses Amblyopia 1% 0%
Abnormal Vision 1% 0%
Taste Perversion 1% 0%
Eye Pain 1% 0%
Urogenital Urine Abnormality 1% 0%
Hematuria 1% 0%
Pyuria 1% 0%
* Six double-blind, placebo-controlled clinical studies in narcolepsy, OSA, and SWD.
1 Events reported by at least 1% of patients treated with PROVIGIL (modafinil) that were more frequent than in the placebo group are included; incidence is rounded to the nearest 1%. The adverse experience terminology is coded using a standard modified COSTART Dictionary.
Events for which the PROVIGIL (modafinil) incidence was at least 1%, but equal to or less than placebo are not listed in the table. These events included the following: infection, pain, accidental injury, abdominal pain, hypothermia, allergic reaction, asthenia, fever, viral infection, neck pain, migraine, abnormal electrocardiogram, hypotension, tooth disorder, vomiting, periodontal abscess, increased appetite, ecchymosis, hyperglycemia, peripheral edema, weight loss, weight gain, myalgia, leg cramps, arthritis, cataplexy, thinking abnormality, sleep disorder, increased cough, sinusitis, dyspnea, bronchitis, rash, conjunctivitis, ear pain, dysmenorrhea4, urinary tract infection.
2 Elevated liver enzymes.
3 Oro-facial dyskinesias.
4 Incidence adjusted for gender.

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 PROVIGIL compared to placebo (See PRECAUTIONS).

Weight Changes

There were no clinically significant differences in body weight change in patients treated with PROVIGIL (modafinil) 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 PROVIGIL (modafinil) , 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) .

Postmarketing Reports

The following adverse reactions have been identified during post-approval use of PROVIGIL (modafinil) . 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: (1) seriousness of the reaction, (2) frequency of the reporting, or (3) strength of causal connection to PROVIGIL (modafinil) .

Hematologic: agranulocytosis

Drug Abuse And Dependence

Controlled Substance Class

Modafinil (PROVIGIL (modafinil) ) is listed in Schedule IV of the Controlled Substances Act.

Abuse Potential and Dependence

In addition to its wakefulness-promoting effect and increased locomotor activity in animals, in humans, PROVIGIL (modafinil) produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like. Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior).

The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).

Withdrawal

The effects of modafinil withdrawal were monitored following 9 weeks of modafinil use in one US Phase 3 controlled clinical trial. No specific symptoms of withdrawal were observed during 14 days of observation, although sleepiness returned in narcoleptic patients.

Read the entire FDA prescribing information for Provigil (Modafinil) »

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Provigil - User Reviews

Provigil User Reviews

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Here is a collection of user reviews for the medication Provigil sorted by most helpful. Patient Discussions FAQs

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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