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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.

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  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.

  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

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