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A New Drug that Treats BOTH Insomnia and Pain?

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Sleep and Pain

Sleep is an essential component of life. Unfortunately, for many of us with fibromyalgia and other chronic illnesses such as ME/CFS, sleep can be extremely problematic. Throw in the common experience of pain with insomnia, and you have a recipe for disaster. If you don’t get enough sleep, then the pain is worse.  But if the pain is worse, then you can’t sleep. 

Most people with fibromyalgia have an associated sleep disorder that makes it difficult for them to get the deep, restorative sleep they need. As a result, they do not wake up feeling rested or refreshed. Unfortunately, there are no medications indicated for fibromyalgia that work by improving sleep.  So, many people take sleep aids, either prescription or over the counter.  Equally disturbing, however, is the fact that sleep aids may increase fatigue and brain fog the next day. Mix sleep aids with pain medication, and you have another potential disaster recipe.

Wouldn’t it be great if someone could develop a medication that addressed BOTH sleep and pain?

That medication may be close to approval. Tonmya, one of the four drugs we reported on earlier this year that are likely to be approved for fibromyalgia in the coming years, is a very low dose, sublingual form of flexeril which has proven in clinical trials to provide great improvement not only in sleep quality but also in pain relief. 

Restorative Sleep

Restorative sleep is one of the most important stages of sleep; it’s also one of the most elusive stages for fibromyalgia patients. Restorative sleep is when tissue growth and repair occurs, energy is restored, and hormones are released.  A former study on Tonmya indicated increased restorative sleep (through EEG analysis).  Cort Johnson reports that this increase in restorative sleep was in turn “associated with reductions in pain, fatigue and depression. In a good sign for those in really severe pain, the most recent studies tied together pain levels and sleep quality; those FM patients in the most pain received the most improvements in sleep quality.”

“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,” Seth Lederman, MD, Tonix 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."

Tonmya is derived from flexeril (cyclobenzaprine). Cyclobenzaprine is a drug originally approved by the Food and Drug Administration for short term treatment of acute muscle spasm and is currently one of the most widely prescribed off-label medications for FM. Low dose cyclobenzaprine given before bedtime has shown to reduce the pain suffered by FM patients and to improve the quality of sleep.

Because flexeril is converted into a metabolite called norcyclobenzaprine when given as an oral pill on a constant daily regimen, it can lose its effectiveness over time. Tonmya differs from flexeril in that it is delivered sublingually (under the tongue), which reduces that build up and the subsequent decrease in usefulness. 

Tonix, the developer of Tonmya, has already completed Phase I and II clinical trials and is recruiting participants for the final Phase III trials, the last step before drug approval.

If you're interested in being in the trial, contact Jennifer Underwood at (267) 536-3560 or

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