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Modafinil is a medication that promotes wakefulness.
Modafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
Modafinil may also be used for purposes not listed in this medication guide.
You should not use modafinil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).
Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have a skin rash or hives, blisters or peeling, mouth sores, trouble breathing or swallowing, fever, swelling in your legs, dark urine, yellowing of your skin or eyes, or swelling in your face.
You should not use this medicine if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).
To make sure modafinil is safe for you, tell your doctor if you have:
angina (chest pain);
cirrhosis or other liver problem;
kidney disease;
high blood pressure, heart disease, or history of heart attack;
a history of mental illness or psychosis; or
history of alcoholism or drug addiction.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Modafinil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking modafinil.
It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Modafinil is not approved for use by anyone younger than 17 years old.
Follow all directions on your prescription label. Do not take modafinil in larger or smaller amounts or for longer than recommended.
Modafinil may be habit-forming. Never share modafinil with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away modafinil is against the law.
Modafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
You may take modafinil with or without food.
Modafinil is usually given for 12 weeks or less.
If you are taking modafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and modafinil may be necessary to best treat your condition.
Modafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.
Call your doctor if you continue to have excessive sleepiness even while taking modafinil.
Taking modafinil does not take the place of getting enough sleep.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Modafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Talk with your doctor about what to do if you miss a dose of modafinil. Avoid taking the medicine if you do not plan to be awake for several hours. Skip the missed dose if it is almost bedtime. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
modafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid other dangerous activities until you know how modafinil will affect your level of wakefulness.
Avoid drinking alcohol while taking modafinil.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have:
skin rash or hives, blisters or peeling;
mouth sores, trouble swallowing;
fever, shortness of breath;
swelling in your legs;
dark urine, jaundice (yellowing of the skin or eyes); or
swelling in your face, eyes, lips, tongue, or throat.
Stop using modafinil and call your doctor at once if you have:
depression, anxiety, suicidal thoughts or actions;
hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual;
chest pain, trouble breathing, uneven heart beats; or
the first sign of any skin rash, no matter how minor you think it might be.
Common side effects may include:
headache, dizziness;
feeling nervous or anxious;
back pain;
nausea, diarrhea, upset stomach;
sleep problems (insomnia); or
stuffy nose.
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.
Usual Adult Dose for Narcolepsy:
200 mg orally once a day in the morning
Comments:
-In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
-If continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to and during treatment with this drug.
Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA.
Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:
200 mg orally once a day in the morning
Comments:
-In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
-If continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to and during treatment with this drug.
Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA.
Usual Adult Dose for Shift Work Sleep Disorder:
200 mg orally once a day, approximately 1 hour prior to the start of the work shift
Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.
Other drugs may interact with modafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Modafinil (www.drugs.com/modafinil.html).
Commonly reported side effects of modafinil include: headache and nausea. Other side effects include: anorexia and xerostomia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to modafinil: oral tablet
Along with its needed effects, modafinil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking modafinil:
Less common
Get emergency help immediately if any of the following symptoms of overdose occur while taking modafinil:
Symptoms of overdose
Some side effects of modafinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to modafinil: oral tablet
Nervous systemVery common (10% or more): Headache (up to 34%)
Common (1% to 10%): Dizziness, paresthesia, somnolence, tremor, taste perversion, vertigo, oro-facial dyskinesia, hyperkinesia, hypertonia
Uncommon (0.1% to 1%): Amnesia, migraine, CNS stimulation, incoordination, movement disorder, speech disorder, hypoesthesia
Very rare (less than 0.01%): Tardive dyskinesia, convulsions
Frequency not reported: Cataplexy
GastrointestinalVery common (10% or more): Nausea (up to 11%)
Common (1% to 10%): Diarrhea, dry mouth, dyspepsia, constipation, flatulence, mouth ulceration, abdominal pain
Uncommon (0.1% to 1%): Reflux, vomiting, dysphagia, glossitis
Frequency not reported: Periodontal abscess
GeneralThe development of adverse reactions (skin and hypersensitivity, central nervous system [CNS], psychiatric, and cardiovascular) appear to be related to higher doses; cardiovascular and CNS reactions increase significantly after a total daily dose of more than 400 mg.
CardiovascularCommon (1% to 10%): Palpitations, chest pain, hypertension, tachycardia, vasodilation
Uncommon (0.1% to 1%): Extrasystoles, arrhythmia, bradycardia, hypotension, transient ischemic T-wave changes, abnormal ECG
Rare (less than 0.1%): Increased blood pressure
Very rare (less than 0.01%): Ischemic heart disease
Frequency not reported: Asystole
DermatologicCommon (1% to 10%): Sweating, herpes simplex
Uncommon (0.1% to 1%): Rash, acne, pruritus
Rare (less than 0.1%): Eczema
Frequency not reported: Ecchymosis, serious skin reactions (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms, erythema multiforme)
GenitourinaryCommon (1% to 10%): Urine abnormality, hematuria, pyuria
Uncommon (0.1% to 1%): Urinary frequency
Rare (less than 0.1%): Foul urine odor
Frequency not reported: Urinary tract infection
HematologicCommon (1% to 10%): Eosinophilia
Uncommon (0.1% to 1%): Leukopenia
Postmarketing reports: Agranulocytosis
HepaticCommon (1% to 10%): Increased gamma-glutamyltransferase, increased alkaline phosphatase, abnormal liver function, elevated liver enzymes, eosinophilia
HypersensitivityUncommon (0.1% to 1%): Allergic reaction (e.g., hayfever)
Very rare (less than 0.01%): Multi-organ hypersensitivity reactions, urticaria (hives), angioedema, anaphylaxis
MetabolicCommon (1% to 10%): Anorexia, thirst, decreased appetite
Uncommon (0.1% to 1%): Hypercholesterolemia, hyperglycemia, diabetes mellitus, increased appetite, increased weight, decreased weight
MusculoskeletalCommon (1% to 10%): Back pain, neck rigidity
Uncommon (0.1% to 1%): Neck pain, myalgia, myasthenia, leg cramps, arthralgia, twitch, arthritis
Rare (less than 0.1%): Muscle weakness
OcularCommon (1% to 10%): Abnormal vision, blurred vision, amblyopia, eye pain
Uncommon (0.1% to 1%): Dry eye
Frequency not reported: Conjunctivitis
OtherCommon (1% to 10%): Chills, edema, asthenia, flu syndrome, thirst
Uncommon (0.1% to 1%): Peripheral edema, menstrual disorder
Rare (less than 0.1%): Tolerance, aggravated condition, malaise, fatigue
Frequency not reported: Infection, pain, accidental injury, fever, viral infection, tooth disorder, hypothermia, ear pain
PsychiatricCommon (1% to 10%): Insomnia, anxiety, depression, agitation, nervousness, confusion, emotional lability, abnormal thinking, irritability
Uncommon (0.1% to 1%): Sleep disorder, decreased libido, hostility, depersonalization, personality disorder, abnormal dreams, aggression, suicidal ideation, psychomotor hyperactivity
Rare (less than 0.1%): Hallucinations, mania, psychosis, delusions, suicide attempt
RespiratoryCommon (1% to 10%): Rhinitis, pharyngitis, lung disorder, asthma, epistaxis
Uncommon (0.1% to 1%): Sinusitis, dyspnea, increased cough
Frequency not reported: Bronchitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Modafinil (www.drugs.com/modafinil.html).
December 16, 2020
March 1, 2021
February 15, 2021
March 1, 2021
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January 31, 2021
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