Sleep Improvement for Fibromyalgia Sufferers Possible, Study Shows

Sleep Improvement for Fibromyalgia Sufferers Possible, Study Shows

A new drug being tested in clinical trials to treat fibromyalgia, called Tonmya, is showing promise for sleep improvement and pain reduction.

Tonmya is being evaluated in the 500-patient Phase 3 AFFIRM study in fibromyalgia. The primary outcome measure for this study is a pain responder analysis, which basically means patients report a minimum of a 30% reduction in pain from their baseline after undergoing treatments for 12 weeks.

The drug is taken at night daily, and researchers are seeing that patients are seeing improvements in sleep.

“Our new analyses of the BESTFIT data show that those patients who reported the greatest improvement in sleep quality were the most likely to experience pain relief,” said Seth Lederman, M.D., Tonix’s chairman and CEO. “We also observed that the group treated with Tonmya was approximately twice as likely as placebo-treated patients to be in the top third of reported sleep quality improvement. Among all patients in BESTFIT who ranked highest in reported sleep quality improvement, twice as many Tonmya-treated patients experienced at least a 30% improvement in their pain as compared to those treated with placebo.”

Of the 172 evaluated, 88 patients were treated with Tonmya, and 84 were treated with a placebo. They found that 67% of those taking Tonmya were in the top tier of those reporting better sleep, and had at least 30% reduction in pain compared to the baseline.

In other analyses, the relationships between reported sleep quality and several standard measures of fibromyalgia were evaluated. According to each of the three different assessments of sleep quality, improvement in sleep quality was found to significantly correlate with improvement in pain as well as broader measures of fibromyalgia symptoms and impact.

Data from the study, which is being conducted by Tonix Pharmaceuticals, were presented this month at the 2015 American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Francisco, CA.

Tonix Pharmaceuticals says “These findings may support the hypothesis that improving sleep quality facilitates pain improvement over time, and is consistent with the growing recognition of a reciprocal relationship between sleep and chronic, widespread pain. Nonrestorative sleep has been linked to altered processes in the brain that are thought to be responsible for certain fibromyalgia symptoms.”

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Authored by: Staff

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My gosh if it is like flexerill please stop marketing it like it is a new promise to those of us who suffer so much! I can’t take even a quarter of a 10 milligram of flexerill and I am loopy for the rest of the day. I am allergic to opioids, and a host of other medications. I don’t believe there will be one pill for everyone, I think it is going to be different for everyone. But at least stop taking old meds and modify them like they have promise.

I already take Flexeril so if its the same thing Stop ripping people off! Need something besides what they already have out there without all of the terrible side effects which cause people more missery!

sandy konstantinidis

I have no problem falling asleep……it’s staying asleep and going into REM that I need. I am fatigued 24/7!

Michael S. Bell

Any news of this kind may be good news, and one hopes so. However, chances are the medication will end up being FAR too expensive for most sufferers to afford. On wishes that would not be so.

Bill Cohen

The pharmaceutical firm utilizes a specific method of sublingual delivery. They might also be “packaging” the drug differently (some new method of coating). The action of some drugs in the body may or may not be altered if the “delivery” or rate of absorption or place of absorption is changed. It may be possible, because the drug doesn’t pass through the stomach if it is delivered between your tongue and your gums. I think the jury is still out, although I’m of one mind with the skeptics above.


I read up about the drug and even though it’s cyclobenzaprine, it’s a new formulation.
It’s supposed to be able to be absorbed more readily under the tongue, so works within 15 minutes, rather than trying to time your cyclobenzaprine ingestion to match you bed time in an hour. and you can have lower doses, so you’re not so drowsy. Will keep an eye on it. Would be good if they tested the new formulation against the old, to really see if it’s better.

Janet Komanchuk

Thanks Krissy!

Kristine (Krissy)

Janet, you can go to Tonix Pharm. website. I have followed their public reports for awhile but I don’t know anything about the trials. If John S is right and it’s similar to Flexiril, that’s one of the oldest muscle relaxers used for Fibro. So basically I don’t know a thing! 🙂 But Google it and subscribe to some alerts. Maybe you’ll get some answers.

Jackie T.

New drug my ass! It’s cyclobenzaprine (Flexeril). I’ve been on it for years! It does help with sleep. Don’t tell me it’s a new drug when it’s the same ol’ shit…..please. Don’t insult my intelligence.

It’s Cyclobenzaprine the same chemical used in Flexarill


Why change the name – it’s Flexarill a muscle relaxor and its been used for years.

Getting rid of Opiates will open up a multi billion dollar market.

Please don’t piss down my back and tell me it’s raining.


John S

Diane Succio

Well I sleep an average of 2 hours daily from pain. I hope this works and doesn’t cost my kids college fund to get it.

Janet Komanchuk

Restorative sleep helps the body to heal. Sleep deprivation intensified all of my other fibromyalgia symptoms including pain. Is there any information on the side effects of Tonmya?