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
28 Comments:
How effective is actually Provigil for ADHD? Any of your own experience?
It's a MIRACLE DRUG for ADD.
It is the best thing, ever! The fact that it was not approved for ADD means so many people will have to suffer on terrible stimulant drugs, which are much worse.
Dear Dr. Sogn, 11/13/06
My name is Missy M., I am an R.N. with extensive backround in phychology. My question is this: I have been diagnosed with OCD, and ADD for the last 10 years. I am on Anafranil 50mg qd, and was on Cylert 37.5mg as needed. With Cylert no longer available what is your best Tx. for my condition. Also my son who will be 19 (who also has ADD (which I have controlled enviormentally for many years) Is now feeling the reprocussions in college. He, and I have also had a lifelong, mild tic of cringing when excited or stressed. Is there a link with Tourettes and ADD/OCD? I would greatly appreciate your input. I am fascinated by the genetic, and neurotransmitter problems linked to these syndromes.
T.Y.
Nurse Missy
Hi Nurse Missy,
To ask Dr. Sogn specific questions, please post to his ADHD Medications and Treatments board here at WebMD. :-)
As someone who has ADHD, fairly severely as a child, a Dr.-supervised test trial Ritalin did not help with my symptoms and I had a severe adverse reaction to the medication. I was tested before and after taking the medication. My mother put me on the all natural Feingold diet which entails avoiding artificial flavors, colors, and preservatives as well as certain other foods. I fared very well on the diet.
I have ADD and I am also taking medications that make me so tired I cannot function. I have been taking provigil 400mg the max and it is the most useless drug, I still cannot function and my ADD is the same. I'm going back to stimulants they DO work for me. I have heard from others that this med is VERY hit and miss and 85% of the time it's a miss. The 15% that it works for it works good. I know that the ampinphitamine based stimulates have very bad side affects but there not "terrible" drugs like the lucky but ignorant 15%er posted earlier. A Stevens-Johnson rash (a less common side effect of provigil )is not a pretty site, permanent sever scaring is almost always left. Also this drug is only 12 years or so old so there may be long term effects that are just as bad or worse then the effects of the stimulants you hate, so don't start a bashing drugs that work for many. Stimulants can be very hard on your body esp your kidneys and heart there also addicting but provigil also has an addictive potential all though much less. Stimulants are safe as long as your heart is healthy and your kidney function is monitored. This being said provigil would be my choice and the previous poster is lucky to have the drug that looks like the safer choice work for them but it's not a "MIRACLE DRUG for ADD" it's the option that works for you. Also why did there drug company want a new name with the approval? Money! This drug cost my insurance over $400 and patents only last so long. This is the same as the Prozac/SaraFem, Wellbutrin/Zyban both Bupropion even though they try to hide it. It is a scams and I'm glad the FDA dropped it. I hope that it's approved if they try again without pulling this name change stunt. As far as my insurance knows I have "narcolepsy" every smart doctor knows this if they want you on it they will help you. This would have made this drug harder for you to get HMOs don't like to pay new ADD drugs and it would make this drug none generic for many more years. If the FDA wanted to be of use for once they would stop this drug company patent scam.
I am recovering from traumatic brain injury. I was in an auto accident in June of 2004. I was in a coma for 14 days. My doctor suggested Provigil to help me stay focused and pay attention longer than I was able to. My brain couldn't fuction the way it used to. In about 7 months I was able to handle my daily living experiences without 24/7 assistance. Within 10 months I was able to drive and go back to work. My insurance wouldn't cover Provigil because it isn't FDA approved for traumatic brain injury (TBI). Thank goodness that my docotor was able to give me samples until he was able to convince my insurance company that Provigil would help me. With the recovery I have made, I owe a lot of thanks to Provigil.
Dear Dr. Sogn- I have OCD and Depression. I have been on Anafranil for at least 20 years. I cannot tolerate SSRI's. It was recently found that my tricyclic levels were affecting my liver!(is this common). I am back on Anafranil but will be having blood tests. Any suggestion about what else I could take?
B-anonymous
Provigil has changed my son's life for the better. Now he smiles and laughs and can stay more focused. Thank God his doctor heard about Provigil helping kids with ADHD at a medical conference - he has been on it for over 2 years and it's the best thing that has ever happened to him!
I can see why it shouldn't be approved as a standard treatment for ADD- but it absolutely should be considered by health professionals- and if there was such a way- marked that it CAN be effective (so insurance companies would cover it more).
I was diagnosed with ADD as a junior or senior in high-school and tried 2-4 different ADD medications. Two of them didn't do a thing, two of them worked but raised my blood pressure. We then decided to test Provigil and I have been taking it for a couple years now and it is wonderful. Thankfully I have wonderful insurance through my dad's work.
I love Provigil! I had a car accident in 1999 and a traumatic brain injury. I take Provigil because of excessive sleepiness that came with the brain injury. When I have trouble getting my prescription because the insurance company wants authorization, I am reminded how much Provigil helps me. Without it, I sleep every day and can't manage daily activities.
I have ADHD,PTSD and Obsessive disorder. My father is on Ritalin,my half sister was on Ritalin as well as a child. I tried Concerta(time released Ritalin);but couldn't get the dosing right(the doctor left it up to me),so I stopped taking it. Don't know if it would have ever worked.
I also believe I have Auditory Processing Disorder from the ADHD. My stress worsens all of these condtions. In the past I took Strattera;it seemed to work but gave me a fever,bad headaches,the sweats,high blood pressure and fast pulse(tachycardia)and seemed to stop working after a few months. I just started on a 100 MG dose of Provigil and I am on day 3. I think that on the Strattera that it calmed me most of the time but when I was extremely angry,excited,or scared that it insensified that feeling. I am worried that I may have the same effect on Provigil.
Anyone else have similar problems or experiences/input/advise.
I am open for discussions.
Myraina@aol.com
I have been diagnosed with a serious sleep disorder of no REM sleep equivalent to getting up 190 times per night to go to the bathroom. Provigil was started two years after the sleep study and is the only way I can wake up and function although it only lasts three hours. Those three hours help me to shower and dress..
Does anyone know how well provigil and efexor go together?? 'Cause my doctor has me on the provigil.
I've just recently started the provigil back and am concerned that it's making me too manic 'cause I don't have the efexor to balance me. I think.
Does anyone know about efexor generics? Am on the payment plan which is working for Provigil well, but if I don't have the efexor, should I wait on the provigil until I have it? Attempt to find generics?
Provigil changed my life. I have been on anti-depressants and had problems with excessive tiredness. If I could, I would sleep 20 out of 24 hours a day. Many doctors said I was depressed...so that was what I was treated for. Yes, I am depressed, but ever since my doctor prescribed Provigil 5 years ago, my life is night and day difference, literally. I only need 8 hours of sleep now and can enjoy life. Yes, I still have bouts of depression and have tried many drugs and still on some, but Provigil is what changed my life. Before Provigil, it was hell counting the hours until my next nap, taking personal time off work to take a nap, and sleeping all weekend, just to need more sleep.
Off Label Provigil gave me my life back!
I had a traumatic brain injury, in a coma for 5 days and was aralyzed on my left side(temporarily). This happened when I was 10 years old. Now I am 47 and have developed Hashimoto's thyroiditis and pre-menopause hormone imbalance. My doctors believe that my TBI is the main cause of my
vigilance problem and that the other imbalances have a greater effect on me. My physiologist was
able to get my Provigil covered after many letters to Blue Cross on my behalf. I have extreme muscle fatigue and spasticity(TBI)and the Provigil helps the fatigue as well. If I miss a dose I fatigue from the simplist tasks.
This headline may be misleading.
From what I've read, I understand that Sparlon was a formulation of modafinil (Provigil) targeted for children. Cephalon's initial application for approval of Sparlon was put on hold as FDA requested more data on its safety, specifically with respect to Steven-Johnson syndrome -- the extremely serious skin rash mentioned. (It's worth noting that Cephalon's original trials reported only one case of S-J syndrome, and that in a pediatric patient.)
After this second review, FDA declined approval of Sparlon, and (as I recall) mandated a warning on Provigil that it not be used for children. However, Cephalon had already voluntarily told physicians not to prescribe Provigil for children.
This FDA action does not (as far as I can tell) change the status or legitimacy of Provigil as an ADHD therapy for adults. No cases of S-J syndrome were reported in adults, and Provigil continues to be approved for adult narcolepsy and shift-work syndrome. Insurance companies can continue (or not) to cover Provigil for ADHD. However, Provigil remains extremely expensive, so its benefits would have to be major to justify its cost.
i take provigil with lexapro and it works very well for me.I feel great..but everyone is different.I no longer struggle to stay awake and is great for my fibromyalgia.I feel like a new person.love it.Always ask your doctor first about mixing prescriptions.Like I said,everyone is different.
I have depression, generalized anxiety disorder, ADD, and sleep apnea (whew!). On top of all that, I'm a recovering alcoholic/drug addict. While Provigil IS a stimulant, I've found it's euphoric properties to be much less than other stimulant meds. I take 200mg on awakening at 7am. For me, it stops working around 3 and I have to take another 200mg dose which wears off around 11pm. In other words, Provigil only gives me about 8 hours of effect per dose. It does help with my ADD, and without exacerbating my anxiety. However, it may be helping with my concentration simply because it makes me more 'awake', and I have excessive daytime sleepiness from the sleep apnea (yes, even using my CPAP machine). With all that said, it works for me and is milder than the other stimulants. I like that. The only downside is trying to get your insurance company to pay for it. Cephalon is raping people's wallets with the price of this drug!!
I was the chief of a medical research lab at major medschool/hospital. Husband is MD. My university student son&I have ADD. Have done extensive research ,gone to international CHADD meetings,met top ADD docs(for 20+yrs.)
I have triedCylert,Ritalin,Adderal,Dexadrine,PLUS, biofeedback, psych.counseling,coaching,vitamins & nutrients,exercise,etc. My son has tried Ritalin,Adderal,bio-feedback, no-sugardiet,etc.Best results for son(20's)-Adderal,for me(50's)-Dexadrine. My brother(56) has Multiple Sclerosis(plaque mostly in cerebellum,brain,C!&C2 of spinal cord -at brain stem) Also has Chron,s disease(auto-immune)&ADD. His top neurologist prescribed Provigil,along with his "heavy duty"MS drugs. Provigil has allowed him to keep working(on board of directors of Fortune 500 co.),&function as well as can be expected,when his disease is in remission. He gets very tired, but takes Provigil at 6 AM,works'til lunch,naps, takes 2nd Provigil dose, works for a few afternoon hrs.;dinner,bedtime. Without the Provigil, his cognitive abilities were taxed. Such a brilliant mind-I'm so glad he's still able to use it-although slower. He said,"I only wish I had had Provigil in HS&college-I can only image what I could have achieved!" I was prescribed Provigil by top "sleep" doc from Stanford,Mass.Gen., in 2000. No side effects,worked well(to combat results of sleep apnea.)Rec .trying Provigil for adultADD.Haven't seen research for children. Did not experience any type of rash,etc. Felt AWAKE,not jittery. March14,2008 2:00PM,EST
What can result from using 1600-2000mg of provigil daily?
I don't know if Provigil works on ADD or my depression, but it does keep me from living from naptime to sleep time. I have been taking it for several years. Now that I am on Medicare I can't get it and from time to time buy 20 tablets. Today I bought my 20 tablets and the price had increased by $30. From $199. to $227.
Is provigil none for raising your blood pressure?
I've been taking Provigil for a couple of months to combat Fribromyalgia, depression, cronic back pain, and all the drug that go with those deseases. It helps tremendously, but I don't know how long I can afford it. Does any know about how long it will be before there is a generic.
Anybody know how to get an insurance company to reverse their denial, even after an appeal, to cover Provigil? My neurologist gave me samples after Amantadine didn't work to help me deal with the fatigue I experienced from my MS. Insurance won't cover it because it's not I don't have a sleep disorder. I agree, it's a MIRACLE DRUG! I can be such an effective member of society if they would just help me cover the cost of this drug.
I have ADD/Apnea/depression the drug is alot milder then some of the other stimulants I've taken in the past such as Adderall/ritilian/straterra.
it was working great in the frist three months it's only been six months lately it's not doing anything though.
I've been taking 400mg just once in the morning it seemed when i was taking it twice a day the first dose didn't kick in till about the time i was going to take the second dose 5hrs later
I can't believe how difficult insurance companies and now Medicare make approving Provigil is. I have been diagnosed with Hypersomnia. I've had the night sleep study (Polysomnography) and the following day the MSLT (Multiple Sleep Latency Test). The Mean Sleep Latency to all 5 naps was 4.8 with the shortest being 2.0 and the longest 8.5. Latency to REM was 17.0. If I had gone into REM in a second nap, they would have diagnosed me with Narcolepsy. Without the Provigil I've ended up on the other side of the road with my car during the day. Pretty scarry. Besides, of course, when you're that sleepy you can't focus on anything nor do anything with unbelievable effort and struggle to stay awake. I can't believe the drug is so hard to get and sooooo expensive!
My heart goes out to all of those who are suffering with ADD and depression. I started taking Provigil a couple of weeks ago. Sometimes a get a boost of energy and I don't feel the onset of depression. Then there are other times when the Provigil makes me feel worse. I suppose it depends on the person. I don't take the Provigil regularly because I can only get sample packs without having any insurance. But the one thing that did work well on my depression and ADD was 10mg. Adderal. I had energy and felt good about myself and could concentrate. Like I said, some meds work differently for others. When you dont have insurance, money or your underinsured, not getting the meds that work for you feels like a slow death sometimes. I wish all of you wellness and happiness.
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