Is Provigil Effective for the Symptoms of
ADD and ADHD?
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 a
medications 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:
_ 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 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, non-hormonal form of birth control while
taking Provigil, and for one month after stopping Provigil, to
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.
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.