Phoenix Rising Newsletter - Xyrem

Discussion in 'Fibromyalgia Main Forum' started by znewby, May 23, 2009.

  1. znewby

    znewby Member

    Here is an interesting article on xyrem. Does anyone know if xyrem is available in Canada?

    Sleep Patterns in CFS Patients and the Immunomodulatory Effects of Sodium Oxybate in Patients with Alpha Intrusion. N. Hone, L. Garcia, M Vera, N Chediak, M Fletcher and N. Klimas.
    Dr. Klimas is a big fan of sleep studies –she believes that virtually everyone who can get one should – (but be sure to get the right kind of sleep study!) and here, in a pretty nice sized study (61 patients), we got a good look at the sleep problems present in chronic fatigue syndrome. One problem sleep researchers seem to be focusing in on is called ‘alpha intrusion’. Alpha intrusions refer to an intrusive kind of brain wave pattern that shows up in chronic fatigue syndrome, fibromyalgia and sometimes sleep apnea patients that interferes with deep sleep. The study looked for alpha intrusions and various other sleep maladies.

    Alpha intrusions showed up in spades with 80% of patients displaying them. But that wasn’t the only problem; almost 50% of patients had obstructive sleep apnea and 25% had restless leg syndrome. Men had particularly high rates of alpha intrusions; about 50% higher than was seen in women.

    In the image to the left the alpha intrusions are on the bottom. Note how prevalent they are in the last two patients.

    Dr. Hone, who is based in Mexico City used sodium oxybate (xyrem) to treat the alpha intrusions in 27 patients. She reported that almost all reported improvement in their sleep, what Dr. Hone called Unfortunately no quantitative data was given and it’s unclear just how strong that effect was but Dr. Hone characterized xyrem has having ‘a high impact in the clinical improvement of sleep’.

    Conclusion: The morale of this study was that treatable sleep disorders of one sort or another are rife in ME/CFS and that sodium oxybate may be helpful in treating a very common sleep ailment.

    Xyrem is a central nervous system and respiratory depressant. Xyrem is the trade name for gamma-hydroxybutyric acid or GHB, a neurochemical involved in regulating metabolism that is able to affect sleep. Sodium oxybate is the active ingredient in Xyrem. Xyrem has been approved to treat narcolepsy (severe daytime sleepiness) and cataplexy (sudden muscle weakness) and is in the last phase of clinical trials for fibromyalgia.

    Xyrem May Work in ME/CFS/FM Because it assists with sleep and reduces pain. Specifically it is the only drug known to reduce the frequency of types of brainwaves (delta intrusions) that appear to impair deep sleep in ME/CFS and FM. It is also one of the only drugs known to improve both sleep and reduce pain. It may enhance the activity of two neurotransmitters, dopamine and serotonin, that may be deficient in ME/CFS. The highest concentrations of GHB are found in two areas of the brain that are of great interest to ME/CFS/FM researchers; the hypothalamus and basal ganglia.

    ME/CFS Physicians. Dr. Teitelbaum flatly states "Xyrem is the most effective way known to increase deep sleep and raise growth hormone". Dr. Peterson reported that to his ‘amazement’ Xyrem helped with both sleep and pain in his ME/CFS patients with extreme sleep disorders. Drs. Ross and Marion Hauser call it ‘probably one of the safest and most effective sleep aids that we know of.” They believe it may enhance growth hormone levels.

    Studies. Two studies have found improved sleep and about a thirty percent reduction in fatigue and pain scores in fibromyalgia. Of particular interest was Xyrem’s abiity to reduce the frequency of anomalies observed in both FM and ME/CFS during sleep called alpha intrusions. Alpha intrusions involve the appearance of unusual high frequency brainwave patterns that are believed to disrupt deep sleep.

    ME/ CFS patients Report – Click here to view ME/CFS patient’s reports on Xyrem.

    Dose. Dr. Teitelbaum recommends 9 cc's (4.5 grams) at bedtime and then about 4 hours later if needed. Xyrem is fast acting and should be taken in bed.

    Side Effects. Xyrem can be habit forming. Patients in clinical trials reported confusion (2.5%), depression (3.5%), incontinence at some point (7%), sleepwalking (4%). Headache (22%), nausea (21%) and dizziness (17%) and others were also found.

    Warning. Do not take other sleep enhancing substances (alcohol, pain medication, muscle relaxants, sedative hypnotics, etc.) when taking Xyrem. Xyrem should be discontinued gradually. Rinse well with water and swallow after taking as Xyrem can damage tooth enamel.

    Others. GHB is known as the date rape drug because of its ability to induce amnesia when combined with alcohol. It can only be obtained from a special compounding pharmacy. Its tight regulation has pushed up its cost to approximately $200-$500/month but is generally covered by insurance.

    Dr. Levine, Klimas and Dr. Bateman have all endorsed sleep studies. In sleep studies patients are given a room to sleep in, hooked up to various machines and then monitored as they sleep. Because sleep studies can be expensive - costing as much as $2,000 - patients may wish to get preauthorization from their insurance company before doing one. A group of ME/CFS physicians recommended that the clinicians use a good sleep questionnaire (such as the Pittsburgh Sleep Quality Index) to determine whether a sleep study would be effective. (If a sleep study is not feasible' Dr. Teitelbaum recommends doing a 'home sleep study' (see below).

    A Sleep Disorder - Not Chronic Fatigue Syndrome (ME/CFS) - Sleep studies indicate that about 20% of ME/CFS patients have a primary and treatable sleep disorder – not ME/CFS. These patients can be rapidly treated and cured.

    Other than consistently finding unrefreshing sleep, sleep studies of ME/CFS patients have had mixed results. Some indicate ME/CFS patient have disturbed ‘sleep architecture’ (i.e. too little REM or deep sleep’) while others have not. Several recent studies finding evidence of increased sympathetic nervous system activation suggest that ME/CFS patient may never really relax when they sleep. Dr. Bateman notes that the commonest findings in ME/CFS sleep studies are movement disorders, jerking, and wiggling, and needing to move. With this kind of problem she says "You wake up all night long, but never enough to know you have a problem; that creates daytime sleepiness." Ken Friedman a ME/CFS researcher and advocate recently reported that a sleep study indicated his daughter woke up ‘hundreds of times’ a night. He was able to use the results of this study to adjust her therapy and improve her quality of life.

    Sleep Study Recommendations. Dr. Klimas recommends that patients see a neurologist rather than a pulmonologist for their sleep study because ‘pulmonologists are usually looking sleep apnea and study results don’t show that’s the kind of dysfunction that CFS patients have." Dr. Teitelbaum notes that sleep studies should include an EEG to provide sleep stage data, waking and total hours of sleep, respiratory monitors to measure airflow and blood oxygen and checks of leg movement (restless leg syndrome) and upper airway resistance syndrome (UARS). He also recommends that ME/CFS patients stay on their sleep medications while they do the study. "If money is an issue patients can do a 'split-night' study in which the sleep technicians look for sleep apnea in the first half of the night and try to fix it in the second.

    A Do It Yourself Sleep Study - Videotaping yourself while you sleep can't tell if you have upper airway resistance syndrome (UARS) but it can tell if you snore, if you stop breathing at times or if you have move around a lot at night (have restless leg syndrome). If none of these are evident then sleep disordered breathing may not be a problem for you.

  2. Juloo

    Juloo Member

    From experience, I agree 100% with what the article states. And when this finally filters through to the insurance companies, and they start paying for it, I'll be on it again.
  3. cfsgeorge

    cfsgeorge New Member

    This is a great article because it summarizes the reasearch and opinions of doctors. I have not used Xyrem/GHB yet, but it sounds like our best bet for treating FM and CFS. People should definitely look into real treatment with Xyrem before using A/D's, Opiates, and Amphetamines to mask their symptoms IMPO.

    For those who have been lucky enough to use Xyrem, can you give us your feedback? thank you.
  4. bakeman

    bakeman New Member

    my last 3 visits, my dr brings it up each time and i always push it off, next time i see him, i'm going to give it a shot. right now i am on so many strong drugs for sleep and it feels like im taking sugar pills, they barely do anything. i will report on xyrem.
  5. Juloo

    Juloo Member

    I'm going to do the short version, but here it is:

    It took me several months to find the right dose, but when I was taking it at the optimum conditions, I would wake up in the morning naturally and be able to go about my day like a normal person without even thinking of napping. It really is a wonder.

    But you must be committed. Cannot eat for several hours before taking it. Those taking two doses a night (common prescription -- I ended up doing just one) need to set an alarm to wake up for the second dose (but it's worth it!). Also, sometimes when you're titrating and the dose is only slightly too high, you can wake up during the hours it is working and get VERY nauseated and vomit. And you do NOT want to wake up while this stuff is working -- it's a bit like being in a fun house. (And not a FUN fun house.)

    On the other hand, it leaves the body very quickly.

    I ended up taking a tiny dose of zolpidem a few minutes before so I would fall asleep fast enough for me not to fight the effect of the Xyrem -- if you fight it, it's quite odd, if not a bit claustrophobic, to feel your body fall asleep before your brain.

    It's only the price which prevents me from taking it now -- I'm holding a half bottle in reserve for emergencies.
  6. cynicaldog

    cynicaldog New Member

    My partner and I have been wanting to try Xyrem since we first heard about it a couple of years ago via the Fibromyalgia Network newsletter. I know that when I sleep properly (which is a rare occurrence), I feel so much better. We have a pain management doctor who's very liberal about prescribing opioids, but became apoplectic when we asked about Xyrem. "Why would you want to take a date rape drug", he asked incredulously. He really went down a notch in my eyes after that statement... we're two middle-aged women. What on earth does he think is going to happen to us in the safety of our home when we take this medicine to sleep? I wish I'd thought to tell him that the Ativan and Xanax he so easily prescribes could also be "date rape drugs" if someone was so inclined... any medication can be abused, especially if mixed with alcohol.

    In any case, I do hope Xyrem is approved for the treatment of FMS, and then maybe he'll reconsider (or at least, not be so pompous).
  7. cfsgeorge

    cfsgeorge New Member

    Juloo-we really appreciate real-world feedback. thank you. Sounds like it really worked wonders for you. It is the price and the lack of knowledge about this drug from both patients and doctors that is holding back millions from trying it. Can i ask how long you had to take xyrem before you felt "normal"?

    cynicaldog-Don't let the "date rape drug" label prevent you from trying Xyrem. It's not the drug/knife/gun/etc, it's the rapist.The only concern for us is its medicinal value and that is how your doctor should have looked at xyrem. I would print out some information and clinical studies about xyrem and give it to your doctor. Btw, xyrem is being applied for a New Drug Application(NDA) this year and will be fda approved for FM sometime next year.
  8. DemonFairy

    DemonFairy New Member

    We (cynicaldog) and I brought info to the doctor, *and* he called the drug company while we were in the exam room with him. He talked to them for a few minutes and asked them to send information to him...and then, nothin'. I guess he's still concerned that we're going to date-rape each other or something. LOL. We would really love to try it, at least one of us, to see if it helped. The studies sounded so promising. We even had it planned so that only one of us at a time would use it, so the other was fully functional. Maybe when more studies come out and when the Xyrem people actually walk into his office and tell him about it. Yeah, one of his reasons was, "I haven't had a drug rep come by to talk about it." Geez, drug reps are his trusted sources of info??? We've already had to tell him about Xyrem, Reboxetine and a couple of others meds. Maybe if we wore a drug rep nametag or something, he would believe us. Or, I suppose he could actually read the Fibromyalgia newsletter every four months - we learned that it existed because he's advertising it in his office. It has pretty much all the latest information about meds.
  9. AuntTammie

    AuntTammie New Member

    it sounds like you really need a new Dr.....I would NEVER trust a Dr who relies on drug reps for info

    btw, there are some valid reasons that xyrem is used as a date rape drug and other sedating drugs are not (NO, I AM NOT FOR OR AGAINST IT BASED ON THIS ....& I CERTAINLY DON"T THINK THAT YOU PLAN TO USE IT FOR THAT PURPOSE - just passing along some info)...the reasons are that it causes almost complete memory loss (at least when used with alcohol) and it passes out of the body very if a rapist uses it, his victim will likely have little to no memory of what he did AND even if she does, there will be no evidence left that he used it.....other drugs do not have these effects, so even though they could be used to subdue a victim, the victim would likely remember what happened and there would probably still be evidence of the drug being used if she had a blood test
  10. bunnyrabs

    bunnyrabs New Member

    Many other sedating drugs also effect memory. Look up the terms retrograde amnesia and anterograde amnesia. Benzodiazepines such as Klonopin, Xanax, Ativan, etc. can cause anterograde amnesia. Remember the date rape drug called "roofies"? That was a benzodiazepine known as Rohypnol.

    Ambien has been linked to amnesia and nocturnal behavior as well. People have been pulled over by the police while under the influence of Ambien. They had no idea how they got in their car and drove in the middle of the night.

    Alcohol by itself can cause memory loss and still remains the king of substance-assisted date rape. Ever known anyone who, after having too much to drink, would "black out" and then not remember anything they did during their drunken state? I saw it many times in college. Lots of date rapes happen on campuses around the nation when parties and lots of alcohol are involved.

    No drugs that cause sedation should be mixed with alcohol, and Xyrem is no exception.[This Message was Edited on 05/28/2009]
  11. cfsgeorge

    cfsgeorge New Member

    All benzodiazepams like rohypnol(banned only in US due to hysteria again) and even xanax can produce amnesia the next day when overdosed. the same can be said for alcohol intoxication. You don't get amnesia from ghb unless overdosed or mixed with alcohol.

    Alcohol is the and will be the number#1 date rape drug forever. should we ban alcohol which is also the #3 cause of death and disease in the US. probably a good idea along with it's #1 big brother, cigarretes both have no medicinal value. they just kill, kill, kill.

    The bigger picture is not to blame the drugs but to blame the rapists. drugs don't rape, rapist rape. guns don't kill people, people kill people. now let's get off this date rape crap and concentrate on the medicinal value of GHB in treating FM and CFS. That is all we are concerned about. this hysteria is due to the dam anti-drug government propaganda. there war on drugs is also a war against patients rights to medicine. thank god for obama and the AG. they are so smart and look at the facts and patient needs, not some crazy propaganda and hysteria propagated by the DEA and right wing idiots..

    it should be alll about the science and the patient needs so let's not fall into the artificial hysteria produced by the government's endless war on drugs. They've made every recreational drug illegal except cigs and alcohol, just to re-package them and made legal by the pharmaceutical companiesl. Don't even go there with me on this as i could right you a few books on this subject. The big picture is that it's all about the $$$ to the pharms and to keep and expand as many law enforcement jobs and jails as possible. big brother want to get bigger and bigger. We house 25% of all jailed people in the world while we are only 5% of the population. something is not right is it?

    DemonFairy-get a new doc. his mind is obviously warped into thinking xyrem will only be used to date rape and have no medicinal value. call him ignorant.either way, it's not your problem, it's his. so get a new doc. i may have to do the same myself. i don't think my PcP will prescribe it to me because he knows nothing about it. i am going to provide all the literature to him. if he won't do it, then i guess i'lll go see dr silverman for it. Remember other people's ignorance is not our ignorance and is not our problem. we are all way too sick, exhausted, and in pain to worry about misusing it. we are not rapist. We are all suffering from a debilitating disease. please, it's just common sense.
  12. cynicaldog

    cynicaldog New Member

    I don't think DemonFairy and I are quite ready for a new doctor, yet, although we definitely were upset by our doctor's condescending dismissal of Xyrem as a treatment. For one thing, neither of us have health insurance, and now that I've seen what Xyrem will cost, we won't be able to afford it. That makes the issue of whether or not the doctor will prescribe it sort of moot (at least for now). When the drug gets FDA approval we may pursue the subject with him again, and then we can also see if the manufacturer offers a program for low-income patients.

    Other than the Xyrem issue, it's tough to complain about our doctor. I see people on this board who are treated terribly by their docs, and who can't get prescriptions for anything but Lyrica and antidepressants. Our doctor gives us any opioid we request (we've tried everything from oxycodone to methadone to Duragesic patches, and everything in-between), he gives us Ativan/Xanax/Halcion/or whatever else we want to try for sleep (...except Xyrem :)), he offers muscle relaxants, gives me my Cymbalta for free, and one of the other doctors in the practice ordered a 6 months supply of Provigil for me for free from the drug reps. We're limited financially in terms of what meds we can take (I really feel great on both Oxycontin and Duragesic but can't afford them now), but our doctor has been great about wanting to treat our pain and brain fog. I've been treated like a crazy person by other doctors who want me to treat my FMS with things like vitamin b12 injections and psychiatric care, so I feel really, really lucky to have our current doctor. Like I said, I'm willing to let the Xyrem issue slide until it's actually approved by the FDA for FMS, and then maybe we'll see if the doctor's mind is more open.

    Thanks for your concern, though, all of you. I've just had so many bad doctors that it's hard for me to consider leaving a guy who not only prescribes almost all the meds I need, but who's *always* exactly on time with his appointments!
  13. Juloo

    Juloo Member

    The next time an uninformed doctor makes a statement like that above, just tell him that you understand only approved physicians who have been through the education program and are registered may prescribe Xyrem. Even patients are required to be educated before they may receive Xyrem.

    As to how long it took me to feel 'normal' -- that's a multi-part question. When I was on the right dose, I was awake all day within a couple of days. But at first, the initial dose just made me more sleepy during the day. My doctor's initial call (even though she had been educated) was to suggest I *lower* the dose. But that only made it worse. When I called the Xyrem hotline, their suggestion was to *raise* the dose. What was happening is that the initial dose was not strong enough to take me all the way into deep sleep. So I didn't get the sleep I needed and I was tired throughout the day. Increasing the dose helped me get all the way down into deep sleep, and then I was AWAKE during the day.

    It really does help to do your homework to understand the finer points of this medication.

    My second dose (the second dose is supposed to help you for the second half of the night AND drop you a little deeper into slow wave sleep) was just not cutting it -- that second dose was putting my poor tummy over the line, and I would wake up nauseated and my head swimming. Ugh. I worked on stopping food four hours before bed, but that didn't stop it consistently enough. So I settled on a single dose and didn't do the second. This seemed to be the right combination for me. Some people need to take a lot more or less. It bears sticking with it if you can stand finessing it.

    After I'd been on it for a couple of months, I went off, due to financial reasons. The effects of it stuck with me for several weeks after -- almost as if had trained my brain.

    A year later, I went back on it again for a few months. The same effect happened again.
  14. cfsgeorge

    cfsgeorge New Member

    Thank you for taking the time and your precious energy to give us such a detailed feedback. This is the best feedback i've read on Xyrem.
  15. agcgmom

    agcgmom New Member

    OK, this is the third time I am attempting to reply to this post.

    My doctor talked about xyrem for a year before I was ready to try it. I was on all the typical meds for FM and was feeling awful. Nothing was helping, just making me sicker. I have now been on xyrem for 5 years and it is the best thing I have done to combat my FM. I am off all the wicked meds and I feel pretty good. I am able to work full time and my life in general is better.

    I take an ambien to get to sleep and I will sleep for 1 hour. When I wake from the ambien I take my first dose of xyrem and will go into a deep sleep for 3 hours then wake and take the second dose and again 3 hours of deep sleep. It may sound like a lot of work and not a lot of sleep but it is the quality of sleep that makes the difference. I feel rested and alert throughout the day. I can wake in the middle of the night for an emergency (I found out the hard way) and it is very uncomfortable but I can function.

    I know that the literature about xyrem is scarry but it is actually a very safe med when used as directed. It has made a night and day difference in my life. I looked at the prescription summary this weekend and the price was $1669 for a month. I pay a $50 insurance co-pay.
  16. bunnyrabs

    bunnyrabs New Member

    How was it when you started on Xyrem? Is the sleep onset different than other meds? When I take a muscle relaxant like Flexeril, the sleepiness seems to feel natural, but when I take a tranquilizer like Xanax, it really pulls me into sleep whether I am ready for it or not.

    What about waking up and moving about during a dose? Is it different than other sleep meds? From what I've read, it seems as though you have a strong drunk feeling. On other sleep meds I can get up and move about but sometimes my coordination isn't so great, but maybe that is just what happens to anyone who is awakened during the night and not necessarily the medication.

    Why did you have to add Ambien into the mix, was the Xyrem not putting you to sleep on its own?
  17. agcgmom

    agcgmom New Member


    I started on the lowest dose (3g I think)and if I remember correctly, it did not get me to sleep. Then I titrated up to my current dose (4.5). It took a week or so I think. It still took 15-30 minutes to fall asleep with the xyrem even with the ambien. It will put me to sleep whether I am ready or not. I don't take the ambien until I am ready to go to bed and it still takes up to 30 minutes to fall asleep then when I wake up an hour later, I begin the xyrem. I occasionally get up for the bathroom between xyrem doses and can feel a little light headed but can certainly manage. I had to wake for an emergency once in the middle of a dose and a strong drunk feeling is accurate plus nausea. I could function and I remember everything but it was tough. I was fine once I got back to bed and I woke up fine the next morning.

    I was on ambien for about a year then added the xyrem. The ambien alone does not give me enough sleep. My Dr originally prescribed 20 mg a night but insurance wouldn't do that. He told me that 20 mg ambien is a common prescip in Europe and he was not happy with the ins co. I still take 10mg ambien. Ambien CR was completely ineffective. Originally, my Dr had me take the ambien and xyrem at the same time but I figured out I get an extra hour of sleep if I take the ambien first then take the xyrem. This has been a good plan for me. Eveyone has to find the right mix and we all know how difficult that can be.