Provigil Dropped as ADHD Medication
The company that makes Provigil, Cephalon Inc., has decided to not market the drug for AD/HD (it was to be marketed under the name Sparlon).
Provigil is authorized by the FDA for daytime sedation related to narcolepsy and to treat sedation from changing shifts at work, and has been found useful in potentiating the effects of antidepressants. Several studies found Sparlon effective for AD/HD in approximately 50% of children, adolescents, and adults.
Since Sparlon works on different neurotransmitters than traditional stimulants used to treat AD/HD, it is sometimes effective for people who don't respond to other stimulants. It is also not a controlled drug and refills are permitted.
Sparlon was awaiting approval from the FDA. Unfortunately, the FDA advisory panel recommended "non-approval" because of concerns over the possibility of a rare but serious rash, and recommended the drug company conduct a 3,000-patient clinical trial to rule out its occurrence. Cephalon decided to not proceed with additional studies.
This decision does not mean that a physician cannot prescribe Provigil for AD/HD, but it is an expensive drug that might not be covered by someone's insurance if not prescribed for approved conditions, such as narcolepsy.
Related Topics: Choosing the Right ADHD Medication for Your Child, The ADHD Child and ADHD Teen: Minimizing the Side Effects of ADHD Medications
Technorati Tags: provigil, adhd, ad/hd, stimulant medications
Provigil is authorized by the FDA for daytime sedation related to narcolepsy and to treat sedation from changing shifts at work, and has been found useful in potentiating the effects of antidepressants. Several studies found Sparlon effective for AD/HD in approximately 50% of children, adolescents, and adults.
Since Sparlon works on different neurotransmitters than traditional stimulants used to treat AD/HD, it is sometimes effective for people who don't respond to other stimulants. It is also not a controlled drug and refills are permitted.
Sparlon was awaiting approval from the FDA. Unfortunately, the FDA advisory panel recommended "non-approval" because of concerns over the possibility of a rare but serious rash, and recommended the drug company conduct a 3,000-patient clinical trial to rule out its occurrence. Cephalon decided to not proceed with additional studies.
This decision does not mean that a physician cannot prescribe Provigil for AD/HD, but it is an expensive drug that might not be covered by someone's insurance if not prescribed for approved conditions, such as narcolepsy.
Related Topics: Choosing the Right ADHD Medication for Your Child, The ADHD Child and ADHD Teen: Minimizing the Side Effects of ADHD Medications
Technorati Tags: provigil, adhd, ad/hd, stimulant medications
