Provigil is an interesting drug. It keeps narcoleptics from
falling asleep and it also appears to help people with Attention
Deficit Disorder (ADD) and Attention Deficit Hyperactive
Disorder (ADHD) stay focused. But how effective is Provigil for
ADHD? That depends entirely on which study you review since
Provigil has shown mixed results in studies related to ADHD
treatment. The results of one study published in July 2000 were
so disappointing that the manufacturer of the medication,
Cephalon Inc., decided to pursue other indications for the drug.
Then, in February 2001, the Journal of the American Academy of
Child and Adolescent Psychiatry published the results of a study
that indicated potential benefit of Provigil (monafinil) as a
once-daily ADHD treatment. The most recent research, performed
by the manufacturer in an effort to gain FDA approval, showed
“significant improvement” when compared to a placebo. Your body
will be the best judge of Provigil’s worth as an ADD and ADHD
treatment. But before you run to your doctor’s office asking for
a prescription, there are side effects and warnings you need to
be aware of. Provigil (modafinil) Side Effects: _ Headache. _
Blurred vision. _ Dry mouth. _ Nausea, vomiting, abdominal pain.
_ Constipation or diarrhea. _ Sleep disturbances/insomnia. _
Loss of appetite/weight loss. _ Stuffy nose. _ Back pain. _
Confusion. _ Anxiety and agitation. _ Nervousness, aggression,
hostility. _ Unstable moods. _ Depression. _ Decreased sex
drive. _ "Pins and Needles" feeling. _ Rash or itching. _
Dizziness. _ Widening of blood vessels. _ Weakness or loss of
strength. _ High/increased blood pressure. _ Alteration in
results of liver function tests. _ Chest pain. _ Increased heart
rate. _ Drug dependence. _ Allergic reaction. Provigil may be
habit forming and has the potential for abuse and dependence .
You should discuss the abuse and dependence potential of
Provigil with your doctor. This drug should not be taken by
anyone who has been or currently is dependent on alcohol or
drugs. Symptoms of an Provigil overdose might include
excitation, agitation, insomnia, sleep disturbances, anxiety,
irritability, aggressiveness, confusion, nervousness, tremor,
palpitations, nausea, and diarrhea. Before taking Provigil, tell
your doctor if you have; _ Left ventricular hypertrophy. _ Chest
pain. _ Irregular heartbeats. _ History of heart attack. _ High
blood pressure. _ Unstable angina. _ History of mental illness.
_ Kidney disease _ Liver disease. Contact your doctor
immediately or seek emergency medical attention if you
experience any of the following uncommon but serious side
effects: _ An allergic reaction (difficulty breathing; closing
of the throat; swelling of the lips, tongue, or face; or hives).
_ Irregular heartbeats. _ Low or high blood pressure. _
Shortness of breath. Provigil may decrease the effects of birth
control pills as well as implantable formulations such as
Norplant and Depo-Provera. Women should use a second,
nonhormonal form of birth control while taking Provigil, and for
one month after stopping Provigil, to prevent pregnancy. Before
taking Provigil, tell your doctor if you are taking any of the
following drugs: _ MAO inhibitors. _ Tricyclic antidepressants.
_ Valium. _ Other stimulant medications. _ Seizure medications.
_ Rifadin, Rimactane. _ Nizoral. _ Sporanox. _ Neoral,
Sandimmune. _ theophylline. _ warfarin. _ propranolol. Currently
about 20,000 people use Provigil off-label to treat the symptoms
of ADHD. Doctors often prescribe drugs "off label,"meaning they
prescribe the drug for a condition other than what was approved
by the FDA. Though it is legal for doctors to prescribe drugs
off-label, it is illegal for the drugmakers to market their
drugs for off-label uses.
Provigil’s manufacturer, Cephalon Inc., has requested FDA
approval for Attenace, a reformulation using Provigil’s active
ingredient, modafinil. By achieving FDA approval for Attenace
Cephalon will be allowed to market modafinil for ADHD. Attenace
is expected to hit pharmacy shelves in early 2006.
|
