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Modafinil Side
Effects
from the Physicians' Desk Reference®
Other brand names: Provigil
Why is this drug prescribed?
Modafinil is a stimulant drug used to prevent the excessive daytime
sleepiness suffered by people with narcolepsy.
Most important fact about this drug
Modafinil, like other stimulants, has the potential for abuse. It can
alter your mood, perception, thinking, and feelings, providing an
artificial "lift" and potentially leading to a certain degree of
dependence (although discontinuation of the drug does not produce physical
withdrawal symptoms). Make a point of taking only the prescribed dose:
Never increase the dose or take additional doses.
How should you take this medication?
Food does not reduce the effectiveness of this medication. However, it
will delay the onset of action by approximately 1 hour.
--If you miss a dose...
Take it as soon as possible. If you don't remember until the next day,
skip the dose you missed and go back to your regular schedule. Do not take
a double dose.
--Storage instructions...
Store at room temperature.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in
intensity, tell your doctor as soon as possible. Only your doctor can
determine if it is safe for you to continue taking Modafinil.
- More common side effects may include:
Anxiety, depression, diarrhea, difficulty sleeping, dizziness, dry
mouth, headache, infection, loss of appetite, loss of muscle strength,
lung problems, nausea, nervousness, prickling or tingling feeling,
runny nose, sore throat
- Less common side effects may include:
Abnormal ejaculation, amnesia, asthma, chest pain, chills, confusion,
difficulty breathing, difficulty urinating, dry skin, face muscle
spasms, fainting, fever, gum inflammation, herpes simplex, high blood
pressure, irregular heartbeat, joint difficulties, low blood pressure,
loss of muscle coordination, mood swings, mouth ulcer, neck pain,
nosebleed, stiff neck, tense muscles, thirst, tremor, vision problems,
vomiting
Why should this drug not be prescribed?
If Modafinil gives you an allergic reaction, you'll need to avoid it.
Special warnings about this medication
If you have high blood pressure, liver disease, or a history of
psychosis or drug abuse, use Modafinil with caution. Be sure your doctor
knows your medical history before you begin this medication.
Modafinil should be avoided by people with certain types of heart
disease such as mitral valve prolapse. If you've ever had a heart problem,
be sure to check with the doctor before using this drug.
Modafinil may impair your judgment, thinking, or motor skills. You
should not drive a car or operate hazardous machinery until you know how
this medication affects you.
Oral and implantable contraceptives are less effective while you are
taking Modafinil. You should use an additional method of contraception
while you are taking Modafinil and for one month after discontinuing this
medication.
Possible food and drug interactions when taking this medication
The effect of combining Modafinil with alcohol has not been studied.
It's considered wise to avoid alcohol while taking the drug.
If Modafinil is taken with certain other drugs, the effects of either
could be increased, decreased, or altered. It is especially important to
check with your doctor before combining Modafinil with any of the
following:
Antidepressants such as Effexor, Elavil, Pamelor, Paxil, Prozac, and
Tofranil
Carbamazepine (Tegretol)
Clomipramine (Anafranil)
Cyclosporine (Sandimmune)
Diazepam (Valium)
Itraconazole (Sporanox)
Ketoconazole (Nizoral)
MAO inhibitors such as the antidepressants Nardil and Parnate
Methylphenidate (Ritalin)
Oral contraceptives and hormonal implants
Phenobarbital
Phenytoin (Dilantin)
Propranolol (Inderal)
Rifampin (Rifater)
Theophylline (Theo-Dur)
Warfarin (Coumadin)
Special information if you are pregnant or breastfeeding
The possibility of harmful effects during pregnancy has not been ruled
out. If you become pregnant or plan to become pregnant, tell your doctor
immediately. Modafinil is recommended during pregnancy only if the need
for therapy outweighs the potential risk.
It is not known whether Modafinil appears in breast milk. Tell your
doctor if you are breastfeeding an infant. Nursing mothers should use
Modafinil with caution and only when clearly needed.
Not for children under 16.
People over 65 may need a lower dose if they have liver or kidney disease,
which reduce the body's ability to metabolize this medication.
Overdosage
Any medication taken in excess can cause symptoms of overdose. If you
suspect an overdose, seek medical treatment immediately.
- Symptoms of Modafinil overdose may include:
Aggressiveness, agitation, anxiety, confusion, diarrhea, fluttering
heartbeat, insomnia, irritability, nausea, nervousness, sleep
disturbances, slow blood clotting, tremor
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"In
the United States, methylphenidate was placed in Schedule II of the
Controlled Substance Act in 1971.
This action was based, in part, on a review by the Department
of Health and Human Services (DHHS).
The recommendation by the Secretary reflected advice from the
National Academy of Science/National Research Council Committee on
Problems of Drug Dependence and the Commissioner of the Food and
Drug Administration. Both
recommended that methylphenidate be placed in Schedule II of the
CSA. It was found that
methylphenidate’s pharmacological effects are essentially the same
as those of amphetamine and methamphetamine and that it shares the
same abuse potential as these Schedule II stimulants".
The
Drug Enforcement Agency
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