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)
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 Provigilís worth as an ADD and ADHD treatment. But before you
run to your doctorís office asking for a prescription, there are side effects and warnings you need
to be aware of.
Provigil (modafinil) Side Effects:
_ Blurred vision.
_ Dry mouth.
_ Nausea, vomiting, abdominal pain.
_ Constipation or diarrhea.
_ Sleep disturbances/insomnia.
_ Loss of appetite/weight loss.
_ Stuffy nose.
_ Back pain.
_ Anxiety and agitation.
_ Nervousness, aggression, hostility.
_ Unstable moods.
_ Decreased sex drive.
_ "Pins and Needles" feeling.
_ Rash or itching.
_ 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
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.
_ Other stimulant medications.
_ Seizure medications.
_ Rifadin, Rimactane.
_ Neoral, Sandimmune.
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.
Provigilís manufacturer, Cephalon Inc., has requested FDA approval for Attenace, a reformulation
using Provigilís 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.
- Name: Jeannie Virtue
- Date: 09/14/05 at 16:45
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