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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. Dr E says:

    Hi Sue
    The Savella, Lyrica, Cymbalta group has been found vastly disappointing and now Lyrica is being linked with birth defects.
    Basically all the facts you make in your e mail are correct including the one on overdoses. I agree that carefully taken opioids should not be classed with heroin overdoses. In my book Healing Fibro, I discuss the bad behavious of male physicians toward women in pain. If you simply have no access to methadone and hydrocodone, you might ask about time release tramadol combined with tme release cyclobenzaprine

  2. Sue jones says:

    Please help me I have fibro so badly I have been taking flu piton for 6months I feel a bit better but can’t even clean my house I’m on so many tablets but I never get a good nights sleep the cremation sounds so good but how do I go about getting it and what about all my other medication

  3. Marcy Ensminger says:

    Does this mess with a person that takes meds for bipolar disorder and board line personally disorder and depression

  4. Dr E says:

    Hi Marcy
    Savella can’t be taken with other psych meds unless cleared by your psychiatrist.
    Xyrem has become so expensive ($4,500 a month!!!) that no insurance companies are covering it

  5. Janet Rose says:

    R these meds expensive n would Humana plus pay for it?

  6. cliffmaurer says:

    Cost of medications is always variable based on your pharmacy benefit. We recommend patients call their insurance company with questions like this. Your pharmacy may also be able to help determine cost.

    Best,
    Dr M

  7. Aelxa Hill says:

    I was put on Savella back in 2009 and it did help with the Fibromyalgia pain, however…half of my hair fell out over just one week of taking Savella. This happened to approximately 25% of the women in the practice who were put on Savella. I stopped the Savella but my hair did not all grow back. You can now see my scalp on top of my head, and the diameter of the hair shafts of the hair that grew back is half the thickness that it was previously. Definitely NOT worth the pain reduction I got. I have no idea what happened to any of the men,but then most people with Fibromyalgia are women. I went to a different pain management physician and he uses a device that goes by the name Hakomed. This device was invented in Germany and has been used in Europe for decades. In a year I have gone from taking six Nucynta 75mg , six Methadone 10mg,and six Tramadol 50mg each day just to get the pain down from a 9, down to a 6.
    Now I am only taking half of a 75mg Nucynta four times a day. Hopefully I will be able to get off pain medication completely. They call the therapy by the name Horizontal Therapy.Each session is 45 minutes long, they put large pads that look like the ones used with TENS units, but the electrical signal put out is completely different.
    At one point, I had bilateral carpal tunnel syndrome. The electrical nerve conduction test that my neurologist did showed moderate on the left hand and severe reduction on the right hand. The extreme cold pain in my right hand was unbelievable, and I had to have immediate surgery to save my hand is what the neurologist told me. My appointment with my pain specialist was on the same day, and when I told him what the neurologist said, the pain doctor insisted I try the Hakomed machine. He had wanted me to try it for the Fibromyalgia pain a year earlier, but I refused as TENS had not helped me at all and I thought of the Hakomed as just another TENS unit. After one 45 minute Hakomed treatment the pain in the left hand was gone and the pain in the right hand was at a 2. It took only a few treatments to have the carpal tunnel to totally go away. Every few months it started to come back, and all it takes is another few treatments to send it away again.
    I wish that it was available for at home treatments, but you have to be a doctor to get the machine. They also have to have the knowledge to use the machine properly, it took a few treatments to find which program would work best on my Fibromyalgia pain. There is no one size fits all, but when they find what works for you it really works to reduce pain.

  8. lucas says:

    Aiden Lucas
    I was diagnosed with fibromyalgia for 3 years, and it was very painful some days. I was taken methocarbamol to relieve the pain. Sometimes it helps and other days it doesn’t. it was killing me for 3 years, doctor said there was no cure. So I tried to live with it and it wasn’t easy.My childhood friend introduced me to Dr George (Good health herbs home),Dr George fibromyalgia herbal remedy cured me within 6 weeks of usage ,am fibromyalgia free now 100%.for more information visit www goodhealthherbshome com

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