Fibromyalgia Patients Take Drug ‘Off-Label’ to Help Them Sleep

Fibromyalgia Patients Take Drug ‘Off-Label’ to Help Them Sleep

Getting a good night’s sleep is one of the many problems faced by people with fibromyalgia.

They may be fatigued and worn out from dealing with chronic pain – but many find that sleeping soundly through the night is nearly impossible.

“I have had several, months-long stints of horrible insomnia,” says Benia Zouras, who often woke up at 2 am and was unable to fall asleep again for several hours. Like many other fibromyalgia patients, she tried Lyrica, Cymbalta, Savella, and opioid pain medicines; and found they didn’t work or had unwelcome side effects.

512px-Tension-headache“Oh my goodness, I was a wreck!  I zombied my way through so many work days,” Zouras says of her sleepless nights.  “I hope that never happens again!”

It hasn’t happened again, thanks to a generic drug that she started taking off-label over a year ago.

Cyclobenzaprine is a muscle relaxant, not a sleep aid, and is not approved by the Food and Drug Administration as a treatment for fibromyalgia. But many fibromyalgia patents have learned through sympathetic doctors and word of mouth that the drug can help them get that elusive good night’s sleep.

“Since starting on the cyclobenzaprine, I’ve been getting pretty good sleep reliably, with very few exceptions,” says Zouras, who also suffers from muscle spasms caused by chronic myofascial pain.

“Although it does not relieve me of my spasms or prevent pain entirely, it is a tool that I believe helps, and even if it only helps me sleep, that is still valuable in my treatment plan.”

Others have taken note of the relief fibromyalgia patients are getting from cyclobenzaprine, which is often sold under the brand name Flexeril. Tonix Pharmaceuticals (NASDAQ: TNXP), a drug development company based in New York City, has created a new formulation of cyclobenzaprine that it claims is superior to the generic version.

The drug, which for now is being called TNX-102, is a low dose, rapid release version of cyclobenzaprine that is designed to be taken at bedtime.

“The branded drug that we’re doing is a very significant improvement over what the generic product can do. The generic dose is too high for a bedtime medicine and it’s not approved for chronic use,” says Seth Lederman, MD, a rheumatologist who is the CEO and co-founder of Tonix.

“I have direct experience taking care of fibromyalgia patients. The only reason I got involved in this and have devoted the past five years to it full time is that what I think we’re bringing to patients is a very important new treatment option.”

In a small Phase II clinical study, TNX-102 not only helped fibromyalgia patients sleep through the night, it improved their symptoms of pain, tenderness, fatigue, and depression throughout the day.

Tonix recently began a second Phase II study involving 120 fibromyalgia patients, but results are not expected until late 2014. Even if the results are good, a Phase III study will then be necessary to satisfy the FDA’s long approval process for new drugs.

Lederman is hopeful TNX-102 will win approval from the FDA in 2017 – not as a sleep aid – but as a front line treatment for both fibromyalgia and post-traumatic stress disorder (PTSD).

Why should fibromyalgia patients wait that long – when a generic version of the drug is already available?

Dr. Seth Lederman

Dr. Seth Lederman

“It’s really challenging for patients to use the generic. I think that what we’re bringing is a very significant improvement,” Lederman told National Pain Report.

“If someone is going to use cyclobenzaprine off-label to get the effect that we’re getting, they really have to go through an elaborate scheme with the patient to tell the patient to cut the tablet in half and take it two hours before bedtime. That’s a very difficult treatment regimen for someone to incorporate into their daily lives.”

It’s a regimen that Benia Zouras is more than happy to have. She takes two 10 mg tablets of cyclobenzaprine nightly – a very high dose compared to TNX-102. Other than drowsiness, Zouras has no other side effects and has stopped taking all other medications.

“As I told my doctor, I prefer to minimize the number of medications I put into my body, especially if there is little or no improvement in symptoms, so I was happy with this approach of trying one drug to do two things.  I was even happier when I was able to confirm that it actually did help me sleep and helped with muscle spasms,” says Zouras, who writes about fibromyalgia on her blog.

“In addition to taking this medication, I strive to eat healthy and stay active and at least stretch my muscles daily to try to prevent problems with them.  I still live in pain, but making these decisions about my health do help me to feel like I have some control over my life, which makes a big difference in tolerating the lifestyle changes I bear to live with my health conditions.”

The potential market for TNX-102 is huge. According to the National Institutes of Health, about five million Americans suffer from fibromyalgia – although some estimate the number could be two or three times higher.

Post-traumatic stress disorder affects another 77 million Americans, many of whom suffer from insomnia, anxiety, depression and other symptoms similar to fibromyalgia.

Authored by: Pat Anson, Editor

There are 10 comments for this article
  1. Brad at 9:27 am

    I deal with alternative or complimentary energy medicine , and have found that when we look at, what makes a healthy body we seem to get a lot further than trying to heal a sick one! If more doctors would come from this perspective, more people would live much happier lives.
    I see very few drugs heal or cure anything and most have complimentary side effects that usually require more drugs ! I have seen some near miraculous recoveries just by adding more water into daily consumption this also helps with sleep , a glass of water before bed ! How simple is that and so much overlooked !
    We also introduce magnets into everyday life , after all are we not people of the earth, and the earth is after all a giant magnet .

  2. susan at 10:22 am

    i would much rather take an old drug say over 50 years old than a new one. At least most of the knowelege re the drug has been known for ions…and the sence of betrayal of ones physician pushing us on a drug that will add 50lbs to our waist line which makes pain 10x worse than it was before… as far as tolerance goes? i’ll deal with that when the time comes. Im not using it for psychological means..so have no guilt. Get rid of guilt and shame in dealing with pain management.

  3. Steve at 10:49 pm

    almost all insurance does cover cyclobenzaprine off label, over half of all prescriptions are off label. only expensive drugs aren’t covered off label, like Xyrem or Actiq

    anyone who purchases the new product is an idiot.

    if i want 1mg of cyclobenzaprine, i take five 10mg pills and dissolve them in 50ml of water, then extract 1ml with an oral syringe. if i want 2mg, i extract. 2ml. I know a lot of people who do this with naltrexone 50mg instead of idiotically paying for compounded naltrexone 2.5mg

  4. Janice Reynolds RN, BC, OCN, CHPN at 7:17 am

    Like any and all medication everyone responds differently. As a pain management nurse I have never been found of this medication however my daughter has Fibromyalgia and it works very well for her. Taking something off-label isn’t always not covered by insurance as well as the generic being more affordable. I would caution about the route of sublingual as unless the drug is lipophilic (which I don’t believe it is, it is not absorbed by the mucosa and the medicine is actually going the oral route anyway.

  5. Bill at 1:14 pm

    Correct, this is just a “mini-dose” of a drug that has been around for decades. One can split the generic pill to get the same effect. The claims of a “re-formulation” or “under the tongue absorption” seem more like minor tweaking to gain a patent, FDA approval, and then insurance reimbursement. One would like to see a large group, comparative blind-study trial comparing the new “miracle method” vs. a split dose of the generic by someone without financial interests in either method.

  6. Benia Zouras at 7:47 am

    As with any medication, the effects will vary from person to person. This is a plan that works fairly well for me, in addition to my other lifestyle changes and treatments. It’s no cure, but it helps me significantly enough to want to let others know about it, in case it might help others. Thank you, Pat, for giving me that opportunity.

  7. Lisa Whited at 9:34 pm

    This did not work for me and I take 10 mg twice daily

  8. Stephen S. Rodrigues, MD at 7:44 pm

    I’ve been using cyclobenzaprine generic for 2 decades and I have found that if it is going to work the cheapest is the best. I’ve even advise 1/4 of a pill. It has a “triple whammy” effect, sleepiness , muscle relaxing and helps the restorative stages of sleep. I think stages 2 and 5. Other companies have being trying to reformulate this old tried and true, but nothing yet.

    Gee, I still use tricyclics to help restore sleep.

    Add in magnesium glycinate and Epsom salt soaks and you will completely address all elements of a good nights sleep.

  9. Mary Miller at 6:31 pm

    I have taken Flexeril off & on for many yr.s, the article makes it sound like a miracle drug….the side effects are….you feel like a zombie the next!morning! ! ! I even tried to just take 1/2 a pill but still too foggy to function…..