Treatment & Research News

Tonmya – Novel Fibromyalgia Treatment but Will it Deliver?

All fibromyalgia medications are “dirty” because they soil up your body with unwanted symptoms. Yet, a new drug is expected to be FDA approved soon and its mode of action is relatively clean. Tonmya (sublingual cyclobenzaprine) treats fibromyalgia pain, sleep, and fatigue without causing weight gain, dizziness, nausea, dry mouth, sexual dysfunction, foggy brain, and other side effects.

Tonmya’s active ingredient is cyclobenzaprine, a tricyclic drug that has been on the market for 50 years. Oral doses of 10 mg are commonly prescribed for relaxing muscles and aiding with sleep (it’s sedating). But this new drug is not an oral pill that’s swallowed. Tonmya is a sublingual formulation with direct action on the brain to target fibromyalgia sleep and pain. In addition, the dose is only 5.6 mg.

Improving Sleep

With fibromyalgia, you don’t just hurt all over, you have a non-restorative sleep pattern that shows up on an electroencephalogram (EEG). Basically, awake like “alpha” brain waves disrupt your sleep (alpha-EEG) and leave you feeling like roadkill each morning. Fifteen years ago, researchers showed that low doses of oral cyclobenzaprine (3-4 mg) at bedtime reduced the alpha-EEG and mildly improved fibromyalgia pain.¹ But despite the low dose, significant side effects occurred (headache, dry mouth, constipation, dizziness).

The above study prompted Tonix Pharmaceuticals to develop and test Tonmya. But they couldn’t just reformulate cyclobenzaprine as a low dose oral pill. A new delivery system was needed to cut the side effects while boosting the drug’s efficacy. Tonix initially tested a 2.8 mg sublingual formula, but it was not potent enough. However, their 5.6 mg sublingual dose shows promise.

Swallowed Vs Sublingual

Ideally, fibromyalgia patients need a drug that goes straight to the brain to provide symptom relief. That’s the strategy behind Tonmya’s mode of action. It’s quickly absorbed through the mucosa to work fast and maximize the amount of drug reaching the brain.

The swallowed “pill” formula is absorbed through your gut to enter the bloodstream (takes more than two hours). Almost immediately, a large portion is converted to norcyclobenzaprine in the liver. Over time, all the drug is switched to this metabolite and eventually excreted. Unfortunately, norcyclobenzaprine builds up in the blood and causes side effects.

If you take a medication to aid with sleep, blood levels need to peak rapidly and fizzle out by morning. The concentration of swallowed cyclobenzaprine peaks four hours after ingestion and its metabolite remains active for 18 hours. Taking a smaller dose minimizes the metabolite’s daytime side effects (drowsiness, dry mouth, dizziness and fatigue). However, the lower dose may provide diminishing returns on sleep.

Cyclobenzaprine works by blocking the serotonin type 2A receptor. Unlike most serotonin receptors, activating this one leads to more pain while blocking it relieves pain. It also reduces the alpha-EEG sleep disturbance. In addition, the drug inhibits histamine (causing sedation) and acetylcholine (causing dry mouth and nausea). Cyclobenzaprine mildly increases norepinephrine, which contributes to fibromyalgia headaches.

The sublingual formula doesn’t produce gastrointestinal side effects such as nausea or constipation. It also limits the drug’s impact on histamine, acetylcholine and norepinephrine, so the side effects are less. And according to Tonix, the amount of norcyclobenzaprine in the bloodstream is reduced by 40 percent.

Symptom Benefits

The clinical trial data on Tonmya shows it relieved several fibromyalgia symptoms during the 14-week study.² Based on 457 patients (half taking a placebo), the sublingual reduces pain, sleep disruption, fatigue, cognitive impairments (fibrofog), and sexual dysfunction. But not everyone responded to Tonmya, so what are the odds it will help you? And how long do you have to take the drug to determine if it works? The answer to the latter question is two weeks.

About one out of five fibromyalgia patients will notice a 30 percent drop in pain while taking Tonmya. The odds drop to one out of ten for a 50 percent reduction in pain. Your improvement odds for the other symptoms are hazy due to the way the data is presented. However, the differences between the drug and placebo group are highly significant for all symptoms. Sadly, not enough men were enrolled in the study to know how they respond to Tonmya.

Side Effects

The common side effects of swallowed cyclobenzaprine are plenty (see above), but what about Tonmya? Most problems occurred in the mouth such as numbness (24%), product abnormal taste (12%), tingling (7%), and tongue discomfort (7%). The systemic effects of headaches and daytime sleepiness only occurred in 2%.

Given the high incidence of oral cavity symptoms, did this unblind the participants? In other words, did the oral cavity side effects lead fibromyalgia patients to suspect they were taking Tonmya and report greater symptom benefits? No. The drug improvements were the same for those who noticed oral symptoms and those who didn’t.

Unlike pregabalin, Tonmya doesn’t cause weight gain or daytime fatigue. Nor does the drug cause sleep disruption, cardiovascular symptoms (blood pressure elevations), or gastrointestinal issues (nausea and constipation). The latter are common side effects associated with duloxetine and Savella. Then again, more Tonmya side effects could crop up after thousands of fibromyalgia patients try it.

Availability?

The FDA put Tonmya on the fast track and the drug could potentially be approved for the treatment of fibromyalgia in August 2025. Of course, there are no guarantees. If approved, Tonix says they can make the drug available within three months. And if you are wondering about the cost, expect it to be pricy.

When pregabalin, duloxetine, and Savella were first FDA-approved, most insurance companies baulked at coverage. Many outright denied paying for the drugs. Others put these medications into the most expensive tiers (brackets) in their formularies. But if Tonmya is truly as good as it sounds for treating fibromyalgia, the insurance industry will soften up. After all, the other treatment options (both drug and nondrug) currently cost them a bundle.

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Tonmya Treats Fibromyalgia References

Moldofsky H, et al. J Rheumatol 38(12):2653-63, 2011. Free Report
Lederman S, et al. Pain Med doi: 10.1093/pm/pnaf089. Online ahead of print. July 8, 2025. Free Report