"Nov. 28, 2012 -- Merck's experimental sleep drug suvorexant helps insomniacs fall asleep faster and stay asleep longer, early data suggest.
Later studies reported at a sleep conference last June confirmed the findings, says W. Joseph "...
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.
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
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
The following serious adverse reactions are described elsewhere in the labeling:
- Serious Rash, including Stevens-Johnson Syndrome [see WARNINGS AND PRECAUTIONS]
- Angioedema and Anaphylaxis Reactions [see WARNINGS AND PRECAUTIONS]
- Multi-organ Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Persistent Sleepiness [see WARNINGS AND PRECAUTIONS]
- Psychiatric Symptoms [see WARNINGS AND PRECAUTIONS]
- Effects on Ability to Drive and Use Machinery [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most Common Adverse Reactions
In placebo-controlled clinical trials, the most common adverse reactions ( ≥ 5%) associated with the use of PROVIGIL more frequently than placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse reaction profile was similar across these studies.
Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in PROVIGIL-treated patients than in placebo-treated patients in the placebo-controlled clinical trials.
Table 1: Adverse Reactions in Pooled
Placebo-Controlled Trials* in Narcolepsy, OSA, and SWD
(n = 934)
(n = 567)
|Abnormal Liver Function||2||1|
|* Adverse Reactions that occurred in ≥ 1% of PROVIGIL-treated patients (either 200, 300, or 400 mg once daily) and greater incidence than placebo|
Dose-Dependent Adverse Reactions
In the placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of PROVIGIL and placebo, the following adverse reactions were dose related: headache and anxiety.
Adverse Reactions Resulting in Discontinuation of Treatment
In placebo-controlled clinical trials, 74 of the 934 patients (8%) who received PROVIGIL discontinued due to an adverse reaction compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for PROVIGIL than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain, and nervousness (each < 1%).
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 PROVIGIL, but not placebo. Few patients, 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 in the placebo-controlled clinical trials. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin.
The following adverse reactions have been identified during post approval use of PROVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Psychiatric disorders: psychomotor hyperactivity
Read the entire FDA prescribing information for Provigil (Modafinil) »
Additional Provigil Information
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