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Two New Drugs for Fibromyalgia That Actually Work

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Regular readers know I’m very skeptical about the claims of new drugs, especially those advertised on TV with a voice at the end of the commercial reading the side effects at the speed of a tobacco auctioneer (I always listen carefully for “death,” that ultimate side effect).

You’ll see no commercials for either Savella or Xyrem on TV, the first because its manufacturer, Forest Laboratories, doesn’t believe in direct-to-consumer ads. The FDA hasn’t yet approved Xyrem for fibromyalgia, though it will likely get an FDA blessing by year’s end. However, many fibromyalgia physicians are prescribing Xyrem off-label, informing their patients about the pending FDA status. The Xyrem story is especially interesting, I think, but let’s take a look at both drugs.

Savella (milnacipran) has been used in Europe for fibromyalgia for about five years with excellent results. Though they’re largely unaware of it, Europeans are guinea pigs for the American pharmaceutical industry, trying drugs before they’re approved here. Savella acts by raising brain levels of stress-buffering serotonin and a second neurotransmitter, norepinephrine, which is involved in focus and energy. Although milnacipran is a unique molecule, the effect is theoretically similar to combining an SSRI antidepressant (like Lexapro) with a psychostimulant (like the attention-deficit disorder med Adderall).

The clinical results in US studies, which had to be completed before FDA approval, have been impressive. Researchers tracked about 2000 fibro patients, 95% female, after three and six months of taking Savella. They asked about improvement in pain, improvement in overall perception of “positive change,” and improvement of physical function. In all categories, Savella scored significantly greater than a placebo (dummy pill).

Researchers knew what the main side effect would be before anyone swallowed the first pill. When you do anything to raise norepinephrine, you feel nauseated, and nausea did turn out to be the number-one side effect. To avoid this, patients start at a dose one-tenth of the maintenance dose and gradually increase it. Headache and constipation also occur, but less often. Anticipating your next question, no weight gain occurs with Savella.

If you start Savella, any drugs you’re taking that raise serotonin need to be tapered down (not necessarily discontinued, but lowered). Otherwise, Savella can be used with most other medications.

In my own practice, I’m seeing very positive results, with fibro patients reporting significant pain reduction as early as 2 to 3 weeks after starting Savella. The nausea component, if it occurs at all, seems to go away after ten days or so.

Xyrem It was almost 20 years ago when I first learned from a massage therapist that the chemical that would ultimately be released as Xyrem could help fibromyalgia patients. “It’s pretty hard to find these days,” she said. “You know, it’s got a terrible reputation.”

“Terrible reputation” was an understatement. Gamma hydroxybutyrate, or GHB, was available over-the-counter, but was rapidly being withdrawn by the FDA because of its high abuse potential. If you’re thinking, “I’ve heard of GHB…” you’re right, it’s the date-rape drug, a Mickey Finn of a sleep med that’s easily mixed with an innocuous drink for nefarious reasons.

How could GHB be helpful in fibro?

Researchers discovered what fibro patients already knew. On those rare nights where they slept deeply and well, people with fibro had less pain and more energy the next day. With GHB, you undeniably sleep deeply, and back when it was widely available fibro patients who tried it were telling their massage therapists (but not their physicians!) how this drug was helping them.

After years of FDA negotiations, a small drug company got the rights to GHB, sensibly renamed as sodium oxybate. They got rather quick approval for Xyrem’s use in people with narcolepsy, an uncommon condition in which you uncontrollably fall asleep during the day. Over the past year, word leaked out that the company was testing the drug for fibro, but FDA regulations forbade them from talking about it. Recently, however, the clinical trials have been published, with excellent results.

Just as my massage therapist advised two decades ago, get the fibro patient to sleep deeply and she’ll start feeling better.

However, when I first learned about the Xyrem dose schedule, my response was “You’ve got to be kidding. No one will do that.” I was wrong. Despite the strange dose schedule, which follows, patients are willing to put up with it because they do feel better.

1. You’ve got to get completely ready for bed, emptying your bladder, turning off the TV and lights, and getting into bed before taking Xyrem (it works fast).
2. Measure out two doses of Xyrem (it’s a liquid). Slug down the first and turn out the light.
3. You’ll have previously set an alarm clock to wake you in 2 to 3 hours.
4. Wake up, take the second dose, and go back to sleep. (Yes, it’s a re-enactment of the old hospital joke where the nurse wakes you up to give you a sleeping pill). Because the Xyrem is metabolized so quickly, you need the second dose for a full night’s sleep.
5. When you awaken 5 hours later, you know you’ve slept well.

Work with your doctor to make dose adjustments, which are required during the first month.

After about 3 to 4 weeks of sleeping deeply like this, fibro patients sense improved energy and less pain. Side effects are for the most part minor. Some patients report nausea and headache, probably from having such deep sleep. Xyrem can be used with other meds, although naturally any previously prescribed sleep meds become unnecessary and would be discontinued.

Leave a Comment

  1. lorie hannah says:

    i suffer from fibromalatia phariatic arthritus and phoriasis

  2. ken says:

    full steam ahead

  3. Linny says:

    You’re right – I wouldn’t do that! First of all, if I am woken up, I can never get back to sleep because the pain comes rushing back and sleep is then impossible! I take half a sleeping pill and get 5 hours. I don’t see the benefit of this. And I never take new medication in a full dose, only 1/4 or 1/2. If a bad reaction happens, a full dose just makes the time until it wears off longer – a small amount is easier to manage. Sounds awful! Probably tastes bad too!

  4. Magela says:

    How you bay this from Canada .
    I have severe pain for more the 10!years.
    I use cymbalta-lirica- porcacet and oxyneo 20 mg .
    Plus sleeping pills .
    I hope something better help people with fibromyalgia .
    I suffer so much!
    Thank you

  5. Deborah Myers says:

    oh my goodness, can it be true, I had such high hopes for Lyrica, too. “When you wish upon a star…”

  6. Carla says:

    I’ve been on Xyrem since 2005. It is my wonder drug! Without it I am bedridden. This is an old article because Xyrem was shot down by the FDA and not because it didn’t work. It works miracles. Studies were shown and people testified. The FDA turned it down because they were afraid of more GHB getting out on the streets but not about our lives. I’m sure many lives would have been saved if they had approved this for us. They felt there were too many with fibromyalgia so we get to suffer. They approved Xyrem for narcolepsy since the population is much smaller.

    My insurance company has started messing with my medications it is only a matter of time before I lose my Xyrem. I can’t imagine living the rest of my life in bed! If someone could find something like this without GHB that would be such a blessing!

  7. Heather says:

    I have used Xyrem and lyrica for more than 5 years. My pain and exhaustion did not disappear, but they got good enough to function almost normally. I highly recommend them. I’m not diagnosed with Celiac Disease but, becoming Gluton free also helped.

  8. Rosemary Lowry says:

    flare ups: always stress related
    Lyrica reactions not good!!
    Massage for Fibro patients not recommended
    I’ve had this condition for many years diagnosed
    by an alternative medicine doctor before my family
    doctor had even heard of it. If doctors haven’t been taught in Medical School, they don’t believe it. Now even Mayo teaches it. Age 84 and better.

  9. Rosemary Lee says:

    This is the first time I’ve been to your blog. Like you, I always listen to the side effects and wait for “death.” I’m not real fond of a lot of drugs that are currently prescribed for Fibromyalgia for that reason. The weight gain of Lyrica, and the fact that it made me very squirrely, was enough to put me off. I’m now interested in Savella. I didn’t realize the fact about the weight gain. I have thyroid issues so I don’t want anything to add insult to injury. I enjoy your writing! Thanks!
    Rosemary Lee
    Seeking Equilibrium

  10. sal_wer says:

    There is a drug now in 2b phase. It approaches fibromalgia by improving sleep quality. It is owned by Tonix pharma and may be finally approved next year.

  11. Robyn mogul says:

    I’m interested About new medications and studies

  12. IDALYS says:

    Finally some hope,about 2008 I read and researched SAVELLA AND TO MY RHEUMATOLOGIST SURPRISE I TOLD HER ABOUT THIS NEW MED.and at THE TIME SHE QUICKLY STARTED ME ON IT BUT FOR ME IT TRIGGERED MY IBS W/constipation so we had to stop it SINCE my constipation can become very difficult to control now I take lyrica but hatE how though it works it makes me VERY hungry within 8-12 hrs.of taking it and at 227lbs.this is the last thing I NEED I’M TRULY DESPERATE TO FIND SOMETHING THAT WORKS VERY WELL IVE HAD THIS CURSE ALL MY LIFE BUT WAS FINALLY DIAGNOSED IN 06,OCT.NOW I’M 50AND OFTEN FEEL AS IF I WAS dying WITH the PAIN and in N.Y. SOME HOSPITAL F O NOT CARE OR TAKE THIS CONDITION SERIOUSLY SO WHAT CAN I DO

  13. Dr E says:

    All the new meds that came out for fibro during the past four years (Savella, Cymbalta, Lyrica and Xyrem) have turned out to be very disappointing because of the side effects (many of which you described in your letter).
    My current regimen is a simple one (and I discuss this in my book “Healing Fibromyalgia.” These are: (1) Amrix 15 mg in the evening, a time release muscle relaxant, (2) combined with any of several time release pain meds (Tramadol-ER, Nucynta ER, Opana-ER, Oxycontin). Because for some people the effect of the pain meds declines after three months, changing from one to another works well. Frequently increasing the dose is a bad idea because it leads to drug dependence and addiction. Keep pain med doses on the low side

  14. Maureen says:

    This sucks! I knew it was coming but N at such a jolt. I’ve been under close supervision for the last 2 years and I’m being dropped from 10 MG of oxy to Tylenol with codeine. I was on narcotics for 5 yrs for one broken bone to bulging disks. THE AFTER THE FDA CA ME DOWN ON MY DR, FOR FEAR OF HIS LICENCE (understand that part,)But I’m scared, am I going to go through some bad withdrawals He didn’t have time to explain. I’m tired and so disappointed. Nows not a good time. Don’t get me wrong I get it, but not now around Christmas. REALLY!

  15. john schoon says:

    fibro and headaches for 45 yrs. 80 yrs old. sure could use some help.tried almost everthing.

    80 yrs old .headaches and fibro for 45 yrs.all i hear is buckel up. go home and live with it. sure could use some help. willing to be a quiney pig. thanks for being there.

  16. Nancey says:

    I have migraines (since a kid), hypothyroid, asthma, fibromyalgia, lumbar disc issues, and myasthenia gravis. I am on Cymbalta, Lyrica, tramadol, levothyroxine, baclofen, singulair, and mestinon. My MG is mostly in remission, thank God, and I take herbal anti-inflammatories for pain. Because of serotonin syndrome I have to be careful with Imitrex for migraines. The big problem is sleeping. As noted here, when I sleep well I feel pretty good, comparatively. I can find NOTHING, even Ambien, which helps me sleep. This would be a Godsend for me. Of course, I’m 65, and I think my PC Doc and my insurance (am on disability) just want me to die. Well, not planning on it! My primary care doctor is more interested in my cholesterol than my fibro. Need a good doc east of Atl that can help.

  17. Dr. R says:

    To Nancy. You might try looking for a functional medicine doctor at this website; The Institute for Functional Medicine. Good luck. https://www.functionalmedicine.org/practitioner_search.aspx?id=117

  18. Claudia Webb Elmore says:

    HOW CAN I GET THIS DRUG? I am desperate!

  19. Dr E says:

    Hi Claudia
    Which drug are you talking about? Between my article and the comments that follow, several are mentioned.

  20. Patricia Harris says:

    Thank you for this information. I was diagnosed 2003 and was on savella 2010 for 9mos. Had to quit when constipation became a big problem, but it did work for the pain. I am not on meds now, advil when needed try now to over do it, 3-4 days a week but when a flair up comes use it 2x a day. I do take 10ml of ambien but often feel tired and in pain when I wake (like I have been fighting all night) I think it’s just the amnesia
    makes me for get I have not been sleeping well. How can I try xyrem, how much will it cost, and what type Dr.
    Thank you for your help. Pat Harris

  21. Dr. R says:

    To Pat.
    Probably best to start with your primary care physician. Cost will depend upon your insurance coverage…

  22. Laurie says:

    I’ve been on Xyrem for 2.5 years for narcolepsy. I had terrible chronic all-over body pain before starting and it’s gone. The schedule is very worth it. I actually divide the 9g into 3 doses/night with my doc’s approval, because my sleep was so fragmented, it only keeps me asleep for about 2 hours. But once I take a dose, I’m back out pretty quickly. My insurance shells out over $10,000/month for this which should be illegal as it costs pennies to make. I was reaching it’s use for fibromyalgia for a friend when I stumbled on this blog. I hope the FDA will eventually approve it for fibro. For me it was a God-send!

  23. Regina Brewington says:

    I would like to have information about anything new about Fibromylagia .

  24. cheryl says:

    As any fibro patient, always desperately searching for answers.

  25. Victoria says:

    Fibro patient 14 years suffering

  26. Liz Ott says:

    Lyrica and Cymbalta did absolutely nothing for me. Just because a drug is “approved” doesn’t mean it’s actually effective.I started with Savella about 3 yrs ago & it’s been great!!!! There is one problem that I learned the hard way. If you drink an adult beverage, the combination will result in severe nausea and vomiting. Otherwise I highly recommend it. I have been with a pain management specialist for quite some time and we’ve learned that you have to find the right cocktail of meds to work together. A little of this and some of that. Small adjustments to tweak the levels for the individual person. My husband has severe nerve pain from surgical nerve damage. His wonder drug is Gabapentin. Everyone has to figure out what works best for them.

  27. Tammy G says:

    I was in a study with Zyrem. Took the drug for about 4 or 5yrs. Had dangerous & very crazy side effects. One if many was sleep eating, I decided to go off the med. when I got up to eat, sitting in kitchen on my bar stool I feel asleep, feel forward & flat on my tile floor, busting my noise. I decided I was done with this crazy drug

  28. mary senterfitt says:

    I have fibromyalgia, advanced tmj, degenerative disc disease the fibromyalgia has taken over my life I am a Mayo patient but my primary dr is stuck on what I have been using for 3 years I am very interested in the Xyrem I am in so much pain that I don’t know what to do please help

  29. Dr E says:

    Hi Mary
    Xyrem still remains an excellent med for fibro (unlike Savella, Lyrica and Cymbalta which have been very disappointing). The only problem is that very few doctors are willing to prescribe it and even fewer insurance companies are willing to pay for it. As of this month, Xyrem is $4,000 a month. That is not a misprint. Most of the patients who had been using Xyrem were told by their insurers it would no longer be covered. That said, it’s not totally impossible to get Xyrem covered but you and your doctor can expect to jump through a lot of hoops

  30. Ashley says:

    I am 29 years old and I have suffered from insomnia pretty much my entire life. I’ve been to numerous doctors and am currently on a cocktail of Ambien (it stopped working years ago for me) xanex, and 18 (not exaggerating!) supplements a night to fall asleep.. This keeps me asleep for a few hours and then I naturally wake around 2-4am for the rest of the day. I am completely miserable and I don’t feel like there’s light at the end of the tunnel at this point.

    Is it hard to find a doctor in Chicago that would switch me from the cocktail I’m on now to GHB? Is this something that is addictive or life threatening in any way?

    Thank you!

  31. Dr E says:

    Hi Ashley
    If you’re in the Chgo area, just schedule with WholeHealth Chicago and we can try to get the Xyrem. It actually is a safe medication unless misused

  32. A T Thein Dr. says:


  33. Judith Lay says:

    I live in Australia & the thing Doctors give here are anti depressants which I cannot take. Love to hear of anything the lack of sleep makes life miserable.

  34. Dr E says:

    Hi Judith
    Tramadol for pain and cyclobenzaprine as a muscle relaxant are both available in Australia. Taking Ambien (zolpidem) with the cyclobenzaprine should give you a decent night’s sleep
    Rx’s from your doctor are needed for all three

  35. Shannon says:

    I find this very interesting indeed. An old and dear friend sent me the link to this article. I wondered about taking this while also taking Nucynta CR and IR for breakthrough pain, but I noted a comment by the doctor about taking it with additional pain relief medication. I will ask my doctor about this and refer him to this article. My sleep is sooo very erratic, I have a backwards circadian clock to boot. I cannot remember having a refreshing, deep sleep. I just cannot even fathom it anymore. Thank you so much for writing this. I wish it was common knowledge.

    There are so many of us who suffer brutally, with no support system. We must be our own advocates and do the research ourselves, or suffer the consequences. IF we can even find a doctor that will take us on, uttering the words “chronic pain patient” seems to be some horrible, dirty words. Doctor’s offices would immediately tell me, “No, we are not taking new patients!” And promptly hang up. Took me 3 years to find another doctor when mine moved away! 3 years of needlessly suffering without pain medication beyond a lot of Aleve (900mg + per day).

  36. loretta s says:

    would like another doctor’s opinion…i am almost 57 and have suffered with fibro for approx. 1/2 my life…was diagnosed in ’95…and have been on a multitude of medications and combos of meds. i’d try anything and get ideas from other fm sufferers!! the last 8ish years i have have been on a regimen of somas (10 daily) & norcos (6 daily), also gabapentin, lexapro. i have been able to do a job that is very physical…i have always had sleep problems and over the years have tried many different meds…i now have a doctor that is telling me i cannot take that many somas & norcos because i could die…REALLY???! i’m functional & happy! at 1 point i was bedridden for 3 months…i DO NOT WANT TO GO THERE AGAIN!!! i currently have NO insurance..i have had the same pharmacist for 15+ yrs and do not doctor shop! i think i’m going to be completely hopeless…any thoughts?! thanx

  37. Dr E says:

    Hi Loretta
    Your combination isn’t going to “kill” you but all those pills can simply be inconvenient. You probably could get by on three Somas and three Flexerils (a different muscle relaxant) and for pain, use a time release pain med oral morphine called MSContin which is dosed every 12 hours and gives you continuous pain relief. The flexeril and MS contin are both comparatively inexpensive and would allow you to reduce your total number of both Soma and Norco

  38. Regina Brewington says:

    I am very interested in these 2 new drugs for Fibromylagia. Will you keep me posted? TY Regina Brewington

  39. Dr E says:

    Hi Regina
    Since I wrote about these in 2009, there have been some changes. First, Savella has turned out to be disappointing–not as effective as originally thought and a high discontinuance rate among patients because of side effects. Second, although Xyrem does work for fibro, the company was never able to clear the hurdles for FDA approval specifically for fibro. Without FDA approval, insurance companies simply will not cover it. In response to fewer potential customers, the manufacturer had to raise the price to (ready for this) $3,500 a month! (over $100 a day!)
    While not using either of these meds, I have had better success with Amrix, a time release muscle relaxant, combined with TramadolER, a time release pain med.
    I discuss these in my book “Healing Fibromyalgia.”

  40. loretta s says:

    thank you dr e…flexeril doesn’t do anything, nor does skelaxin…like i said, i’ve tried everything & combos over the last 20+ years…just wanted to hear that these doses won’t kill me! which i already knew! i will try and keep up with your blog & maybe learn something i don’t already know about my body & fm…good luck to those who suffer…
    thanx again for answering so quickly!

  41. Kathleen Sowers says:

    I need this drug!

  42. Joy says:

    Have any of you tried Ketamine infusion therapy.

  43. Mary Hansley says:

    My name is Mary and was diagnosed with fibro about 10 years ago. With all the hullaba with this diagnosis I did not believe this is what I have. Now, 10 years later the medication I was taking for pain just up and stopped working (sorry, can’t remember the name of the drug). Now my new MD (the old MD retired who gave me the drug) told me that I needed to be taken off this drug because of heart issues. Have been on Paxil for many years at 40 mg daily so now the MD had me decrease to 20 mg/day which I did for two weeks and now I’m on it every other day. As I sit here and type this comment the pain in my feet, ankles, legs, entire body is really very painful. I see my MD on 12/28/15 and hope she will give me something like Lyrica (does that work)to help me. The only way of course she would give me Lyrica is to be taken off the Paxil. I do have more health issues but will discuss later.

  44. Mike says:

    My wife has been on Butran patches for about 5 years now. They start at 5mg and go up to 20mg. They have seemed to be the only thing that works for her. They are like a nicotine patch as they release a narcotic into your system as needed. So if u do alot of hard work it works faster and the patch runs out. She changes hers once a week and near the end sometimes has to change a day early or takes a tramadol to help get her to the next day. I dont know if anyone else has tried these but if not they sure have helped my wife. Check with your doctor about this option.

  45. Nancy Smith says:

    I could never use that. We have frequent power outs here and no alarm clock would wake me up reliably.

  46. linda says:

    How and where can it be purchased

  47. Dr E says:

    Hi Linda
    Both Savell and Xyrem are prescription only. Your doctor simply writes an rx for Savella and your pharmacist fills it.
    Xyrem is trickier. You need to find a doctor trained with Xyrem and he orders it directly from the drug company. They in turn mail it to you. Insurance companies hate to pay for it because of price, almost $6,000 a month (!!) so they will ask a lot of questions about your need for it. You’ll need to have had a sleep study since it only approved for chronic daytime sleepiness. It never got FDA approval for fibro and your insurance company uses that as an excuse to not pay for it

  48. June Gates says:

    This is great news for those of us who have suffered from fibromyalgia. Could you please send me as much Information to share with my family doctor. It really makes sence to take Savella and Xyrem in the treatment of fibromyalgia.

  49. Dr. R says:

    June. Take a look at Dr. Edelberg’s book, “Healing Fibromyalgia”. There is a section in the book for your doctor.

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