Brand name : MODALERT
(Modafinil,Modalert/Modafinil ,Attenace®, Provigil®)
Pronounced: PRO-vi-jil
Generic name: Modafinil , Modalert/Modafinil ,Modalert
Why is Modalert/Modafinil prescribed?
Although primarily indicated for the treatment of narcolepsy, modafinil
is also used to treat some forms of sleep apnea. Experimentally, modafinil
is being evaluated in the treatment of Alzheimer's disease, depression,
attention-deficit hyperactivity disorder (ADHD), and fatigue associated
with multiple sclerosis.
Modalert/Modafinil is a stimulant drug used to treat unusually sleepy people
who have been diagnosed with narcolepsy, obstructive sleep apnea/hypopnea
syndrome, or shift work sleep disorder. You should be diagnosed with
one of these sleep disorders before taking Modalert/Modafinil, since sleepiness
can be a symptom of other medical conditions.
Most important fact about Modalert/Modafinil
Commercial trade names
* Provigil (US, UK, Italy)
* Vigil (Germany)
* Modalert, Provake, Modapro (India)
* Modiodal (France, Mexico, Turkey, Greece, Sweden)
* Modavigil (Australia)
* Alertec (Canada)
* Vigicer (Argentina)
* Resoty, Mentix (Chile)
Modalert/Modafinil will not cure any sleep disorder; it merely treats the symptom
of sleepiness. This medication should not be used in place of getting
enough sleep. You should follow your doctor's advice about maintaining
good sleep habits.
Modalert/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 Modalert/Modafinil?
Food does not reduce the effectiveness of Modalert/Modafinil. 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.Modafinil is taken by mouth in tablet form.
It is prescribed by physicians in varying dosages, and is usually taken
once a day, in the morning.
Storage instructions...
Store at room temperature.
Modalert/Modafinil side effects
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 Modalert/Modafinil.Research
indicates that modafinil is generally well tolerated. However, modafinil
may case a variety of usually mild side effects. Headache, nausea,
and upset stomach are the most frequently reported side effects of
modafinil. Other possible side effects include excessive difficulty
sleeping, nervousness, depression, diarrhea, dry mouth, runny nose,
neck pain or stiffness, back pain, loss of appetite, and confusion.
Other, uncommon side effects of modafinil can be potentially serious.
Persons taking modafinil who experiences any of the following symptoms
should immediately contact their physician: irregular heartbeat, unusually
rapid heartbeat, shortness of breath, hives or rashes, chest pain,
persistent or severe headache, and persistent fever, pain, or other
sign of infection.
* 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
Why should Modalert/Modafinil not be prescribed?
If Modalert/Modafinil gives you an allergic reaction, you'll need to avoid it.
Special warnings about Modalert/Modafinil
If you have high blood pressure, liver or kidney problems, or a history
of psychosis or drug abuse, use Modalert/Modafinil with caution. Be
sure your doctor knows your medical history before you begin this medication.In
some patients, modafinil may be habit forming. When taking the medication,
it is important to follow physician instructions precisely. Modafinil
may cause clumsiness and impair clarity of thinking. Persons taking
this medication should not drive a car or operate machinery until they
know how the stimulant will affect them. Patients should avoid alcohol
while taking modafinil. It can exacerbate the side effects of alcohol
and other medications.
Modafinil may not be suitable for persons with a history of liver
or kidney disease, mental illness, high blood pressure, angina (chest
pain), irregular heartbeats, or other heart problems. Before beginning
treatment with modafinil, patients should notify their physician if
they consume a large amount of alcohol, have a history of drug use,
are pregnant, or plan to become pregnant. Patients who become pregnant
while taking modafinil should inform their physician.
Modalert/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 Modalert/Modafinil.
Modalert/Modafinil may impair your judgment, thinking, or motor skills. You
should not drive a car or operate hazardous machinery until you know
how Modalert/Modafinil affects you.
Oral and implantable contraceptives are less effective while you are
taking Modalert/Modafinil. You should use an additional method of contraception
while you are taking Modalert/Modafinil and for one month after discontinuing
Modalert/Modafinil.
Possible food and drug interactions when taking Modalert/Modafinil
The effect of combining Modalert/Modafinil with alcohol has not been studied.
It's considered wise to avoid alcohol while taking the drug.
If Modalert/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 Modalert/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. Modalert/Modafinil is recommended during pregnancy only if the need
for therapy outweighs the potential risk.
It is not known whether Modalert/Modafinil appears in breast milk. Tell your
doctor if you are breastfeeding an infant. Nursing mothers should use
Modalert/Modafinil with caution and only when clearly needed.
Recommended dosage for Modalert/Modafinil
ADULTS
Overdosage
Any medication taken in excess can cause symptoms of overdose. If
you suspect an overdose, seek medical treatment immediately.
ADHD
As of February 2007, there are at least seven English-language articles
on randomized clinical trials in humans in the Medline database addressing
the use of modafinil for the treatment of attention deficit/hyperactivity
disorder (ADHD). Some studies have shown the use of modafinil in the
treatment of ADHD is associated with significant improvements in primary
outcome measures. Cognitive function in ADHD patients may also improve
following modafinil treatment, in some studies. Studies for ADHD report
insomnia and headache were the most common adverse effects, seen in
approximately 20% of treated individuals. These studies were not adequate
to demonstrate that the beneficial effects of modafinil are maintained
with chronic administration. Additional large, long-term studies using
flexible titration methods to establish safety and efficacy and head-to-head
comparisons between modafinil and stimulants are needed to determine
the role of modafinil in the treatment of ADHD.[4]
Weight loss
A few studies have indicated that modafinil may have an appetite reducing
effect on some people, leading to weight loss. During 9-week double-blind
clinical trials of 320 mg/day and 425 mg/day doses of modafinil in
children suffering from ADHD, patients receiving modafinil lost an
average of 1.7 kg compared to those receiving placebo.[8]
In an experimental study, the appetite reducing effect of modafinil
appears to be similar to that of amphetamines, but, unlike amphetamines,
the dose of modafinil that is effective at decreasing food intake does
not significantly increase heart rate. The authors of the study concluded
that modafinil may be well suited for the treatment of obesity and
may have less adverse health consequences than some anorectic agents
with a greater effectiveness.[9]
Another article, published in the Annals of Clinical Psychiatry, presented
the case of a 280 pound patient (BMI= 35.52) who lost 40 pounds over
the course of a year on Modafinil (to 30.44 BMI). After three years,
his weight stabilized at a 50 pound weight loss(29.59 BMI). The authors
conclude that placebo controlled studies should be conducted on using
Modafinil as a weight loss agent.[10]
Conversely, a U.S. patent (#6,455,588) on using modafinil as an appetite
stimulating agent has been filed by Cephalon in 2000.
In December of 2004, Cephalon submitted a supplemental new drug application
(sNDA) to market Sparlon, a brand name of tablets containing higher
doses of modafinil (85, 170, 255, 340, and 425 mg) for the treatment
of ADHD in children and adolescents ages 6 through 17. However, in
March 2006, the FDA advisory committee voted 12-to-1 against approval,
citing concerns about a number of reported cases of skin rash reactions
in a 1,000 patient trial, including one which was thought to be likely
a Stevens-Johnson syndrome.[5][6] Final rejection occurred in August
2006, although subsequent follow-up indicated that the skin rash reaction
was not Stevens-Johnson syndrome.[citation needed] Cephalon then decided
to discontinue development of the Sparlon product for use in pediatric
cases, though there is potential for use in treating Adult ADHD.
Modafinil is contraindicated for patients with a history of cardiac
events. However, one 2005 case report [7] positively describes transitioning
a 78 year old with "significant cardiac comorbidity" from
Methylphenidate (5mg b.i.d. ) to Modanafil 200mg daily. For an adult,
10mg of Methylphenidate daily is not an effective ADHD monotherapy[citation
needed], while 200mg is the Modanafil maintenance baseline.[citation
needed] Thus, Modanafil's physiologic (and political) advantages over
conventional ADHD therapies should not be dismissed out of hand, but
rather discussed individually with a physician/neurologist or psychiatrist.
Cocaine/amphetamine
addiction:
In January 2005, researchers at the University of Pennsylvania published
the results of a small study, which found that modafinil may help recovering
cocaine addicts fight their addiction. Similar published case reports
suggest that modafinil might also be useful in the treatment of amphetamine
addiction.
