In keeping with the religious notion of reincarnation, apparently some drugs are destined to be reborn, redesigned, and re-packaged for brand new indications. I've written about Contrave and Silenor for instance—two drugs with generic counterparts that have been re-tweaked and renamed for newer (and larger) markets.
In early April, the FDA granted its approval to yet another "new" agent (that's "new" with an asterisk, mind you), Horizant, developed by GlaxoSmithKline (GSK) and Xenoport. Horizant is a name-brand version of gabapentin, also known as Neurontin. But instead of simply re-labeling gabapentin and introducing it with a new name, GSK made some subtle changes to gabapentin that may provide advantages over the already-available alternative. But the question is: at what cost? And for what, exactly?Gabapentin's bioavailability—the proportion of drug that enters the bloodstream when taken as an oral dose—is rather low (and, paradoxically, decreases as the dose is increased) and the duration of its action is quite short, which means that users need to take this drug three or four times daily. The key advantage of Horizant is that it is a "pro-drug." Technically it's gabapentin enacarbil, and the "enacarbil" refers to a molecule added to the drug which allows it to be absorbed along the entire GI tract, resulting in greater blood levels for a longer period of time.
Interestingly, in early 2010 the FDA rejected Horizant's first request for approval, citing a small but significant risk of cancer. They relented, however, and approved it this year after "reconsidering the risks and benefits." (Specifically, GSK argued that the large number of pancreatic tumors found in rats taking Horizant may have occurred spontaneously, and human data don't show a compelling link between cancer and gabapentin use.)
So who might use Horizant? Well, GSK and Xenoport probably hope that anyone who currently uses Neurontin (and there are a lot of them) is a potential patient. Officially, though, Horizant was approved only for the treatment of restless legs syndrome (RLS).
Now, RLS is one of those "diseases that may not be diseases"—or "diseases that you didn't know you had." (See the articles here and here for accusations of "disease mongering" by GSK [Hey! GSK! Coincidence? I
don't think so!] when it introduced Requip, the first "treatment" for RLS.) In particular, whenever you see a headline like "Disease X may affect 7-10% of the population" when, in fact, no one had even heard of Disease X ten years ago, you have to be somewhat suspect.
Nevertheless, like much else in psychiatry, there may be some reality to RLS; it may in fact be a true pathophysiological entity that responds to medication, and some people report an excellent response to
treatment. (Whether it afflicts 10% of the population is another story.) Current treatment strategies involve dopamine replacement, in the form of Requip (ropinirole) or Mirapex (pramipexole) so maybe dopamine insufficiency is part of the process.
However, the symptoms of RLS are rather nonspecific: "an urge to move the limbs, which improves with activity and worsens with rest." That's about it. Which leads to yet another problem (a problem that GSK and Xenoport don't see as a problem, that's for sure): with such vague and common symptoms (who among us hasn't felt somewhat restless at times, with interrupted sleep?), a lot of people might get diagnosed with RLS when their symptoms are actually due to something else.A while back, a fellow blogger directed me to the RLS "patient page" on the National Institutes of Health (NIH) web site, where RLS was—and still is—referred to as "akathisia." However, these may be two entirely different things. Akathisia (from the Greek for "not sitting still") has long been recognized as a side effect of some—perhaps most—psychiatric medications, from antipsychotics to antidepressants. It is often described as an "inner restlessness," a "need to keep moving." Sometimes it's associated with extreme emotional distress. In terms of severity, it can range from a mild nuisance to—in some cases—aggressive tendencies. (Indeed, the psychiatrist David Healy has even linked psychotropic-induced akathisia to suicide attempts and violent behavior.)
Psychiatrists really don't know exactly what causes akathisia, and disagree on how to treat it. It may have something to do with dopamine blockade, or something completely independent. Treatment might consist of benzodiazepines (like Ativan or Valium), beta blockers (like propranolol), or discontinuing the drug that caused it in the first place.Unlike RLS, which seems to bother people most when they are lying down (hence its tendency to disrupt sleep), drug-induced akathisia is worse when people are awake and moving around. Sounds like a simple distinction. But nothing is quite this simple, particularly when psychiatric drugs—and real people—are involved. In fact, many psychiatric meds can cause other motor side effects, too, involving (theoretically) yet other neural pathways, such as "parkinsonian" side effects like rigidity and tremor. In fact, some antipsychotic drug trials show "restlessness" and "akathisia" as entirely separate side effects (and when I've tried to ask experts to explain the difference, I have never received a straightforward answer.)
What it means for patients and doctors is less clear. A new agent with apparently better availability and kinetics than gabapentin is now available, but it's approved for the treatment of something that may or may not exist (in most patients). It also may or may not be more effective than gabapentin itself, but it will most certainly have a heftier price tag. Ah, the wheels of psychopharmacology keep turning…
Steve Balt is psychiatrist at North Bay Psychiatric Associates in San Rafael, California and writes his own blog: Thought Broadcast.
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32 comments:
Thanks so much for posting this Dan. Steve makes some great comparisons between this new drug and the tactics they use to sell and "grow the brand" with the other psych meds. It's all here, folks:
1) Come up with a fuzzy, ill-defined "disorder" with a broad enough definition to catch many patients (customers!) in its net and rake in the dough
2) Fail to find any scientifically valid biological theory for the "disorder"
3) Tweak an existing generic drug with an extra molecule or two to come out with a "new" brand-name drug. This greatly increases profit and revenue streams by cutting down on R&D costs and by forcing people to cough up the bucks for a name-brand drug.
4) Re-market the old drug for a new use, such as RLS.
-Talk about getting maximum mileage (read: profit) out of an old drug!
*To paraphrase an old truism: It's not so much the corruption that's appalling, it's the fact that people (doctors, patients) continue to allow it to happen that is so appalling. Sigh!
Almost forgot one more goodie the pharma companies use to grow the brand: marketing the disease, not the drug. This is obviously happening big-time with RLS.
For all the reasons I've enumerated above, I consider psychiatry to be the sad clown of medicine. YES, all areas of medicine are vulnerable to the sleazy tactics big pharma uses, but psychiatry is uniquely vulnerable because of the biomedical model it so slavishly adopted starting with the DSM III. As long as psychiatrists see their job security so closely tied to the prescription pad (and truly, what other medical specialty is more chained to the prescription pad than psychiatry?) it will be ever vulnerable to Big Pharma's pill pimping.
And let's not forget psychiatry has a bad case of terminal conceptual confusion (is that a DSM diagnosis?): psychiatrists fear if psychologists begin prescribing, the clinical firewall between psychiatrists and PHds will collapse and they'll have no unique corner on the market. And yet the very "biologically based medical knowledge" they use to study mental disorders is flimsy at best (chemical imbalances anyone?) and when you look at the unbiased studies, you realize so much of the foundation of the biomedical model of psychiatry (increasingly, psychiatry's reason for being) is solid smoke. It's almost tragically absurd. Sad clowns indeed.
Why the hostility towards the new drug? No one can force patient to take the drug, or force doctors to prescribe the drug, or even force the insurance to cover the drug. Without any benefits, the drug will prove to be a loser to the development company. So what is the big deal?
The market will dictate what the pharma company will do. If Horizant is a useful drug to the patient, then similar drugs will be developed. In fact, the trend is that this kind of drugs are not money makers as before. So you will see less and less pro-drugs being developed. I am not sure if it is a good thing or not. But there is no need for such hostility. Really.
Don't you think it is a bit arrogant to tell patients that they don't need another option for treatment, or saying that their illness is all in their head?
I had seen many doctors quick to dismiss symptoms that they had never seen before or unable to diagnose as non-disease. In fact, many of them just pretend that they didn't hear the problems raised by patients. This is really frustrating to patients already. So we don't really need any more of this arrogance.
This post has so much good information in it--I appreciate the discussion about the rather bogus 'RLS' diagnosis and the risks of missing akathisia. I wasn't aware of the 'diminishing returns' aspect of gabapentin dosing either.
In residency, gabapentin seemed to be something to give highly lethal, cluster b patients--probably wouldn't hurt (and nothing else seemed likely to help). Cynical but, sadly, true.
The strange thing is that I've since worked with a handful of patients for whom gabapentin has had enduring, stabilizing effects. One high functioning fellow with bipolar I d/o described gabapentin as 'like aloe on a burn' in terms of its soothing mental effects. I don't understand it, and I probably wouldn't have started him on it (it was already on board), but its occasional utility has been great.
Of course, his experience is just incidental to GSK's quest for market share and profits. We probably won't be switching over--I'd rather I didn't put him at risk for pancreatic cancer.
Those who ignore history are doomed to repeat it. Some adages are timeless, no pun intended.
We already endured the inappropriateness of Neurontin sales pitches, now we are to deal with Horizant? For me, I don't think so!
By the way, in my clinical experience, when I do turn to gapabentin as an intervention, I found I could prescribe it BID most of the time and it seems effective.
Also, can you believe the gall of the company re-releasing trazadone as a brand name drug?
I agree with anon: Don't blame the drug company. RLS is probably a real disorder, but not a psychiatric one. If immediate release gabapentin works just as well, use it. If payers don't want to cough up the extra money for the new drug, they'll leave it off formulary. But more than likely a few patients will find the new preparation better than what they had before. If you don't think FDA should have approved the drug, blame the agency, not the manufacturer. For my part, I'll welcome samples I can give to patients, and when they run out, we'll see how the old fashioned stuff works. If you don't want people to make money from innovation, move to N Korea. And make sure your retirement account and mutual funds don't have any pharma stocks.
clearly you've never met anyone who suffers from RLS. It has a biological basis (mine is anemia which is virtually impossible to get under control) and the implication that there is something invented about the disorder is insulting. Of course everyone has had sleep disruptions and restless feelings, but until you've experienced it, you shouldn't marginalize it.
I do not think Dr Carlat is doing that.No one knows what you feel. That is not the point. It is if RLS is a valid construct meaning if all the people who have "RLS" have the same thing wrong with them. There is no consistent known biological abnormality found in the majority of people who have this Dx. It is a relatively new construct as well. Like psych dx since there are no tests and it is based purely on pt self report, anyone who goes in complaining can get the dx.
You and only you know what you feel. Drs can tell you almost nothing. Don't look for many answers from them.
Another thing about akathisia -- it is a common antidepressant withdrawal symptom, and can persist for many months. It's a terrible, terrible condition, and the sufferer just has to gut it through, as none of the geniuses who so merrily prescribe antidepressants have a clue as to how to treat withdrawal syndrome.
As for Horizant, there have been numerous runs at getting Neurontin approved for all kinds of neuropsychiatric conditions, including anxiety. For a while, it was the arbitrary off-label pill of the month for psychiatrists, now replaced by Abilify. We can expect more of the same for Horizant.
I am a practicing family doc and I love your blog, your insights and your perspective.
Yet experience has led me to the following dissenting observation: Lyrica is an on patent Neuronitin look alike and as much as I like to save money and not endow big pharma's profits I have seen case after case especially in pain management when Lyrica is light years better than gabapentin. So there may be much value in molecular tweaks.
Talking about pharmacology and restless legs syndrome:
No remarks can be made without noting that the long used and cheaper clonazepam is just as effective, if not more so, than the newer profit gauging Requip.
By the way has anyone used Requip to overcome the sexual/libido inhibiting effects of SSRIs? In some cases it works extra ordinarily well.
Can someone tell me how strong the evidence is for using Neurontin for pain, taking into account unpublished studies that have been uncovered through Freedom of Information Act requests? I'm curious because it was prescribed to me some years ago (prior to the scandal), though I opted not to take it because a) it was quite expensive at the time b) it appeared to be something I would be taking indefinitely, as I have a chronic condition c) I felt uncomfortable about taking an antiepileptic for an off-label uses, and d) I'd read that it could cause weight gain. Any clarification would be appreciated.
Nice summary. I'm a pulm trained sleep doc and I was interested to see what you had to post about this new branded medication. My verdict is out. I'm inclined to try it on my handful of patients that have RLS/PLMS and are doing GREAT on gabapentin. I'd be interested to see what their effects are. I agree, it is probably not going to be first in line ahead of the tried-and-true or in line of the $5 generics to try. I don't let branding and propaganda touch me too much. Patients, however, are another another story. For now, I will take my samples, and start my head-to-head trial on my own in a non-control group.
BIZ said
Some good info not understanding it all but enough to ask this. I have had sleep apnia for years and recently took a new sleep study. I was told that although oxigen levels were controled by the CPAC (?) that some muscles are basicly connected directly to the brain and by monitering this during sleep showed that they were sending signals repeatedly wakeing me up without me being aware and with no visible observation thus calling it RLS in some form. Is this making sence to the more knowledable than me. Would and/or will gobapentin be appropriate treatment. RLS would apear to be more of a general terminology for people who know they have some sort of loss of muscle or nerve control along with those who dont even know why thay are haviving various difficulties as a result. How specific a tratment should this drug be. It's a little more scarry that asprin which is proven to treat a wide variety of ailments with a sorted past. I have no idea how this treatment will turn out but time will tell many drugs took years to discover there true healing powers for ailments never origionaly designed for. In the pharmicutical mmarket were all ginnie pigs to some extent, which is obvious by all the possible side effects of all medications. Lets see how it works the side effects seem standard to me which is just scarry in general that their commonplace in the pharma industry
I wish I could come up with a way to describe this, so-called, RLS. Don't complain about the "makers" of these drugs. This is our right to choose! We, the customer, need different choices. I f we pay for it and it gives us relief, then so be it. Mind your own business. I do not have health coverage and for generic and brands meds to get me through the days. I take meds when the lab work proves I have an illness and when I know what I feel. I do not need a blood test to tell me my legs do not stop moving,or when I have to message them for hours in a hot, hot, bath to make the discomfort lessen at 3AM. I think it is one of the worst feelings. Pacing and pacing until you can not do it anymore. I have tried Klonopin and it's generic; Neurontin and it's generic. Finally found the generic for Requip..and a miracle came true. I would not have found it if it was not for all the studies, trials and errors. The thing that bothers me most about this article is that you and others make very light of this complex disorder. I do not want this condition. Believe me , I could think of better ways to occupy my life. I hope and pray you or anyone you know does not come up with this. I hope people you know could come to you and explain their problem. I wonder how much you would care about how much the pharmacy industry is making or if you would truly help them I wonder...would they come to you at all? I hope you post this. You may get a lot of feedback. Cindy.
I haven't read all the posts, but I did read all that Dr. Balt wrote about gabapentin. I only want to respond to the idea that Restless Legs' Syndrome (RLS) is a "manufactured illness." It may be true that RLS does not affect as many people as has been claimed. However, it has made me miserable. I am a 55 yr old Episcopal priest with degrees from two Ivy League universities and a Ph.D. from a British university. That doesn't mean that I'm not crazy (although I don't think I am), but it may indicate that I'm a thoughtful and reasonable person and a pretty good observer of my own health. For as long as I can remember I've had extremely unpleasant sensations in my legs that can only be relieved by near-constant movement. Sometime between 1993 and 1998 these sensations started causing to lose a significant amount of sleep. I used Requip for many years but discovered that the side effects were worse than RLS. I'm hoping that the new gabapentin drug, Horizant, will help.
After reading your post, i would like to tell you that RLS is REAL, I live in the UK, and i suffer with rls, its the worse sleep deprivation condition anyone would NOT want. You dont seem to understand or seem to know how this effects peoples lives. Rls was given its name back in the 40's by a man called Karl Ekbom, so new its not.. Doctor's didnt know how to treat it and most didnt understand it either... People suffered in silence, even in this day and age, there are still some doctors who still dont know how to treat this horrible condition.. I am lucky in the UK to have a doctor who DOES know about rls and treats me with the medication i need which enables me to sleep at night and i dont mean the odd bad night most people can have. I mean being awake all through the night where the rls keeps me awake, getting if i was lucky an odd hour here and there. Thats what rls does, it stops you sleeping all night every single night. Thats why i object to your post saying "no one had heard of disease x 10 ten years ago" and you seem not to believe that rls is real. So once again i am saying RLS IS REAL...
i have had RLS for 43 years now, and it is very real, while most of you are asleep i pace the floor unable to sit down, let alone sleep. It is a very debilitating illness and any drug that will help me i will take. this drug isnt available in the UKyet but as soon as it is i will ask my doctor if i can have it. unless you have witnessed one of your own family suffer from this illnes dont think it isnt real, it is, very much so. and any help we get is welcome, no matter what
It may help readers in the UK to know that Requip, like so many drugs that affect the nervous system, is advertised on television in the U.S.
(The evening news broadcasts are routinely surrounded by drug ads.)
While RLS is real, it probably does not authentically affect so many people to justify saturation broadcast advertising. According to Consumer Reports, an objective agency, about 3 percent of Americans suffer from real RLS.
So much money is spent on this advertising, clearly drug companies intend to profit from expanding use of the drugs past the 3%.
The drug ads convince consumers not only that they have RLS, but that a medication will solve their problem and create a perfect, happy life as portrayed in the ad.
Consumers then go to their doctors and specifically request the medications, which are then prescribed perhaps unnecessarily.
Consumer Reports says: "In a 2006 survey by our National Survey Research Center, 78 percent of doctors said that patients asked them at least occasionally to prescribe drugs they had seen advertised on television, and 67 percent said they sometimes did so." (See http://news.consumerreports.org/health/2007/11/finally-an-anti.html)
This is the way pharmaceutical companies build consumer demand and huge profits for drugs that address relatively infrequent conditions and, not incidentally, promote myths such as depression being caused by a "chemical imbalance."
For the most part, drugs advertised on TV are supposed to be taken chronically, cause dependency or addiction, and have withdrawal difficulties. Many have proven to have questionable health benefits.
I moderate several online groups for RLS, and have since 1997. RLS has certainly been around for longer than 10 yrs. RLS was named in the 40's by a Swedish doctor named Ekbom.
Both of my sisters also have RLS, plus my two nieces. ( yes, the gene for RLS has been discovered) I have over 4,000 members from 16 different countries. Out of these 16 countries, only TWO allow direct to consumer drug ads. So, the people that I have met that suffer daily from this insidious disease ceratinly did not find out about it from a drug ad. There is NO doubt that RLS exists. Yes, many drugs can make it worse. But, for those of us that had been looking for answers for decades before any drug was approved for RLS, the approval of any drug for RLS is a welcome thing for us. Like someone else commented, do NOT blame the drug companies that manufacture these. I was recently directly involved with the struggle we had to get the FDA to approve Horizant. It is MUCH more than a "molecular tweak" to Gabapenbtin. It is , like you said, a pro drug, which means it is transported much more efficiently thorugh our bodies and is a time released form of the drug, so that maybe some people have a shot of actually sleeping thru a night without having to be awakened by our "restless" legs, and having to re-medicate. I also find it extremely tiring to have to actually "educate" medical professionals that this is a real disease that has been around for a long time; is not a NEW disease. It was actually first described by Sir Thomas Willis back in the 1600's, and any medical doctor SHOULD be familiar with him, since a section of our brain is actually named after him. There are issues with the drug companies all the time, just not in this istance. It is up to the doctor and the individual patient whether they feel that this new drug will help, but it is not a true statement that this is "just a new tweaked form of Gabapentin". Patients and doctors are already running into problems with insurance companies who will not pay for this new drug, Horizant, which can actually be a big help to people who are having trouble with RLS. It is bad enough having to fend off the "snakeoil" salesmen who always have a 'cure" for everything. I am just so tired of having to fight and spread awareness on a daily basis, and when I have to do it on a doctor's web site or blog, it is just that much more frustrating. To SG- RLS may be a "fuzzy, ill defined disorder" to you, but I know at least 4,000 people who can define it exactly and tell you how it affects our lives, our relationships, our work situatons, etc. The RLS Foundation is also very real, and RLS Awareness Day is Sept. 23rd. Some of you here need to brush up on your awareness. Anything that can bring on this amount of "sleep debt" is a very serious condition that can lead to many, many other health conditions. I know so many people that have uncontolled RLS, and no approved or unapproved med for it can help it. These are the people I worry about the most. For ME, personally, none of the "approved meds" do it for me. I also have chronic pain issues and am
on permanent disbility, so luckily my pain meds , yes, they are narcotics taken at the same dose for 11 yrs, are the only thing that control my RLS to any degree at all. No one thing works for everyone, but I know many people who ARE helped by Requip, Mirapex, Gabapentin, the Neupro patch ( recalled in the US for ridiculous reasons) and now Horizant. Like one person said here, we would take ANY thing that works, just so to get a little sleep, be able to relax, read a book, watch a little TV, etc. The ridiculous idea that legs are supposed to move, therefore RLS cannot be real, is one I will never stop fighting. It is just really frustrating to have to do this with medical professionals. It took me ten yrs to get a really good team of doctors put together, but it was worth it, and now I feel like I at least am getting some adequate help.
Rls is real!! Unless you have ever experienced it you have no idea how tiring, depressing and life altering it is. I have pain 24/7 which is worse at night and am lucky if I get 2hrs sleep, often I go several days without any sleep and spend most of that time moving about trying to ease my legs. It is not a made up disease or in my head. I would love a full nights sleep or to have a few hours without pain. Any drug that gives us a chance to get relief should be available. You have no right to dismiss something you obviously know nothing about.
I would also like to point out that EVERY single time I see a mentio of disease mongering, the links lead to the inevitable statements by the SAME two doctors. You never see any other quotes or interviews with about this subject by any other doctors except Steve Woloshn and Lisa Schwartz. Interestingly enough, I have seen her father in the spine clinic at Dartmouth, and RLS was the focus of our visit. I do not know if you will post this or my first comment I sent yesterday, but just how YOU yourself describes how HOrizant works, explains WHY this is a good "tweak" as you put it. Less doses will be needed, since it will transported more efficiently thru the body, but it is also a timed release formula, hence less doses. I have had RLS since I was 14, moderate several online support groups for RLS. Mine is very severe, as well as most of my members. But, amke no mistake about it, RLS is REAL, it runs in some famalies. We cannot ignore the fact that the gene has been discovered. That certainly makes it real. Severe sleep deprivation isn epiemic in our country, and RLS is a big part of that.
have you turned off the comments? Just wondering, since I know a lot of people who want to comment. RLS Awareness Day is Sept 23rd, just so you know. Blogs like yours make my day a lot harder, since I have severe RLS, moderate several online support groups, and have had RLS for 30 years, waaay before drug ads hit the airwaves, and the "disease mongering" began. RLS has been around for a long time and millions of people suffer untold agony from this insidious disease. I will personally take any me that works to have some quality of life.
Yes, RLS is real!!! I have suffered with this for a year now with a horrible quality of life from sleepless nights. It has been a two-edged sword. I'm so tired and sleepy. As soon as my head hits the pillow, the movements of both the arms and legs begin. Getting out of bed is the only way to stop the jerking. Have been on gabapentin, klonipin, requip, mirapex and now the newest of all, Horizant. Have been on it for several weeks and doing great. Had a little dizziness the first week, but that symptom has disappeared. I am sleeping all night again and have a good quality of life. Hope it continues!!
I agree with Cindy, Jean and the others. I have RLS that has been on and off and I had used illegal drugs and alcohol at first to numb myself and get sleep but that got out of control and I got completely sober 5.5 years ago. Since then it has become increasingly more severe. It is so difficlut to explain what it feels like but it affects every part of my life. I can't sleep without meds and the meds make it difficult to stay awake during the day (falling to sleep at stop lights and in meetings). This prompted the Doc to put me on Nuvigil to stay awake during the day. NOT the way I want to live! It has affected my work, my sex life, my relationships, etc. I have taken Mirapex with Requip (Max doses of both), Requip and Simimet (max doses of both), Requip and Lyrica (max of requip and 100mg Lyrica). I still wake at least 6-10 times a night. I can go back to sleep but wake up at shorter intervals. I just started taking Horizant with requip after weaning off Lyrica. Immediately I am more awake in the morning. I am sleeping a little better but am only on the initial dose of 600mg. I can only hope and pray this may help. I have had tests up the ying yang including MRI's, sleep studies, blood work, etc. I do not take and never have taken anti-depressants. I could care less if I was in the .01% of the population who have this severe issue. I am just glad that there is some sort of awareness because this has caused so many problems in my life.
I am so happy to read the posts commenting on RLS. Unless you have been there, you cannot explain the ordeal you go through everyday. I take Requip, and it has been a god send. However, I know as soon as I take it, I will begin to get sleepy. I cannot sit down in the middle of the day and read, because I must keep moving to keep the jumpiness away. I cannot go to the movies or a concert, because I cannot sit still.
Someone is suffering from DPCS - Drug Profit Conspiracy Syndrome - the holding close to a paradigm that every new drug is a fraud to bring greedy pharma companies high profits.
I have a low quality of life due to RLS. It may be genetic, because my late father also had it. I also have obstructive sleep apnea and understand there is a correlation with RLS.
I for one am very happy that investors are taking their own money and trying to tweak drugs to improve our lives while making more profits for themselves.
It would be more productive if the author would keep to discussions about the effectiveness and cost/benefit of drugs and avoid a personal bias against drug companies.
If there is evidence that a drug company is intentionally committing fraud or misrepresentation, then by all means publish the evidence.
Robert V.
1. To Jeffrey B: Klonopin does help you remain asleep when you get RLS (PLMD when asleep). It does not treat RLS, just covers it up. And over time, one must increase the dose of Klonopin necessary! Hear your PCP scream when you are on higher doses! Good luck finding someone to give you prescriptions!
2. Opiates treat RLS, but are addictive as well. Some sleep neurologists treat it with Methadone, as it remains in the bloodstream longer, so only single or twice daily doses needed. Methadone creates another problem for some--more awakenings (Disruption of "sleep maintenance") can be a side effect of the drug.
3. Having had RLS since childhood, and not knowing it was something abnormal, I did not get diagnosed with it until I was almost 40. I felt such validation. Now, instead of it being a 'nuisance', it causes me much agony. Am now on Klonopin, Hydrocodone and trying Horizant (Much as I despise Big Pharma making pro-drugs, marketing older drugs for this new use and making big bucks with a new brand name drug which is really an older drug...). It is felt that some who cannot tolerate side effects of Gabapentin might be able to tolerate Horizant.
4. I have also tried all the Parkinson's drugs, no help, made sleep worse, or side effects unacceptable.
5. My experience over the many years? Meds. help, but side effects can be awful. Some can cause other kinds of sleep problems or change the quality of what little sleep I get!
6. RLS, PLMD, other sleep disorders are NOT psychiatric disorders. They are very real neurological disorders. They must be diagnosed by sleep studies (Except RLS, which is more of a clinical diagnosis). They are best treated by reputable sleep neurologists.
7. Look up RLS.org!
8. Diet affects symptoms! Sugar, caffeine make RLS worse. RLS has been associated with Irritable Bowel Syndrome. Take care of your guts! I take magnesium supplements, which seems to help. There is a topical magnesium oil on the market which helps. Epsom salt baths help. I also started taking B12 (Methylcobalamin form!) as it helps sleep. Also tart (Not black cherry) juice has melatonin in it.
9. I take magnesium supplements, which seems to help. There is a topical magnesium oil on the market which helps. Epsom salt baths help. I also started taking B12 (Methylcobalamin form!) as it helps sleep. Also tart (Not black cherry) juice has melatonin in it. Get Vit. D levels checked! Don't accept a prescription for it (Big Pharma Vit. D2), it is the wrong form. Get OTC Vit. D3, have your levels closely monitored, as it is stored in fat, can get toxicity at high levels of supplementation. Better yet, get lots of noon time sunshine w/o wearing sunscreen for ~20 mins., if possible!
10. Exercise helps. Try yoga, tai chi.....
11. Except for Wellbutrin, most antidepressants make RLS worse, as do antipsychotics (Can also cause akathisia as described by other respondents). Nausea meds. such as Phenergan are often weak antipsychotics can make RLS worse! Ditto antihistamines and muscle relaxants.
12. Trying to share what I have learned by experience over the years. Am former physician who has lost trust in drug companies and the FDA. Unfortunately, sometimes a necessary evil. Now pursuing, if I can afford to, alternative therapies for the RLS, depression I have experienced, partially bec. of issues, partially bec. Klonopin and opiates are depressants. Treatment for depression and RLS? Huge catch-22!
13. Meditation! It helps!
14. Keep searching for answers! I found this page by looking for newly reported side effects of Horizant! You never know what you will find. Europe is ahead of us with many treatments for various illnesses.
15. Please forgive any typos. Best of luck with RLS! And if your initials are RLS, like mine, maybe a name change would help! Haven't tried it, yet.....
I find this at best insensitive. RLS has been documented for a very long time.
I've watched my husband suffer from this condition for over a decade.
Because Pharma makes profits or has tasteless marketing styles does not mean RLS isn't real.
Research is now revealing a possible genetic component as well.
For all those of you who read this who are suffering with RLS, there is some help but it remains a struggle even with the meds.
You're not alone. Find a knowledgeable physician.
Ive had rls since Childhood. Remember describing it to my mother at early age and she exclaimed that I had "nervous legs" just like she had. There was no diagnosis for it then. I discovered if I laid in bed backward with my feet pressed firmly against the headboard it provided enough pressure to relieve the horrible sensations in my legs so I didn't have to keep getting up to walk around. This is how I was able to fall asleep for many years. It's gotten better as I've aged. Benadryl makes it worse. oh, my sister has it, too, so it definitely runs in families.
I feel that if this is a doctor calling rls a fuzzy madeup disease, then maybe needs license taken away. I am a real person not taking any psychotropic meds. My dad and sister both have mild rls and I had mild for years until a sciatic nerve injury caused mine to spin out of control. I have been on Requip for almost two years and have become miserable with side effects of Requip making my fuzzy disease worse. I am now affected all day long, cannot read a book, watch a tv show, and stand while on computer. My arms jump at all hours of the day. My doctor has just recently pulled me off dopamine medicine to put me on Horizant. I pray this works and I now pray this idiot of a doctor realizes he does not know what he is talking about.
I have an ill defined sleep disorder that occurred following a viral illness. I sleep all night easliy but awaken unrested. Nothing helped except klonopin but of course I had to raise the dose. Then Neurontin was added and it did quite well. Not 100% but good. I am willing to give Horizant a chance for my problem. I do question if it would be truly more effective than lyrica for RLS or even my problem ( for which lyrica was no better than neuronting ). If it helps even a few people with unexplained symptoms ( and realize we don't live long enough for everything to be fully discovered scientifically ) then it is worth trying and if you feel like I do in the a.m. sometimes then the benefits may truly outweigh any risks. No perfect drugs out there.
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