What is Tonmya?
Tonmya is the brand name for TNX-102 SL, a low-dose sublingual (under-the-tongue) formulation of cyclobenzaprine HCl.
- It is being developed by Tonix Pharmaceuticals (NASDAQ: TNXP).
- It is not yet FDA-approved but is in late-stage clinical trials for fibromyalgia, a chronic pain condition.
- Tonmya is designed to help improve sleep quality, reduce pain sensitivity, and relieve other fibromyalgia symptoms.
👉 In short: Tonmya is a potential new treatment option for fibromyalgia patients who do not get enough relief from current medicines like Lyrica (pregabalin) and Savella (milnacipran).
Table of Contents
Tonmya Uses
The main use of Tonmya is:
- Treatment of Fibromyalgia – Fibromyalgia is a long-term condition that causes widespread body pain, fatigue, poor sleep, and cognitive issues (“fibro fog”). Tonmya aims to improve sleep quality, which in turn helps reduce pain and fatigue.
Other potential research areas for Tonmya:
- PTSD (Post-Traumatic Stress Disorder) – Earlier studies were done, but now focus is on fibromyalgia.
- Sleep disorders linked to chronic pain.
Currently, the drug is not available on the market.
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How Does Tonmya Work?
Tonmya works by targeting sleep quality in fibromyalgia patients.
- Cyclobenzaprine, the active ingredient, is a muscle relaxant that affects serotonin and norepinephrine pathways.
- Taken under the tongue at bedtime, it improves deep sleep cycles (slow-wave sleep).
- Better sleep reduces central pain sensitivity, which is the root cause of fibromyalgia pain.
Is Tonmya FDA Approved?
- As of 2025, Tonmya is not FDA approved yet.
- Tonix Pharmaceuticals has completed several Phase 3 clinical trials.
- If results remain positive, FDA approval may come in the next few years.
👉 Patients often ask: When will Tonmya be available?
Answer: Availability depends on final trial results and FDA review. It could reach the market in the next 2–3 years, but no official date is confirmed.
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Tonmya Dosage
Tonmya is still under study, but in clinical trials:
- Recommended dose: 5.6 mg or 2.8 mg sublingual tablet (placed under the tongue) at bedtime.
- The dose helps improve sleep and reduce pain sensitivity.
- Do not swallow immediately – let the tablet dissolve under the tongue.
👉 Since it’s not approved yet, you should not self-medicate. Dosage may change once FDA approval is granted.
Side Effects of Tonmya
Like any medicine, Tonmya may cause side effects. The most common ones in clinical studies are:
- Dry mouth
- Drowsiness
- Dizziness
- Headache
- Abnormal dreams
- Nausea
Less common but possible:
- Low blood pressure
- Fatigue
- Nervousness
👉 Compared to older fibromyalgia medicines, Tonmya is designed to be low dose with fewer side effects.
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Warnings Before Taking Tonmya
Before taking Tonmya, patients should consider:
- Pregnancy & Breastfeeding – Safety not fully studied.
- Liver problems – Since cyclobenzaprine is processed by the liver, caution is needed.
- Alcohol – Avoid alcohol; it increases drowsiness.
- Driving/Operating machinery – Can cause sleepiness or dizziness.
- Drug interactions – Tonmya may interact with antidepressants, sedatives, and some painkillers.
Drug Interactions
Tonmya may interact with:
- Antidepressants (SSRIs, SNRIs, MAOIs) – risk of serotonin syndrome.
- Alcohol & sedatives – may increase drowsiness.
- Painkillers like opioids – increased risk of CNS depression.
- Other muscle relaxants – may cause excess relaxation and dizziness.
👉 Always inform your doctor about all medicines and supplements you are taking.
Alternatives to Tonmya
Since Tonmya is not yet available, doctors usually prescribe:
- Lyrica (pregabalin) – Reduces nerve pain and improves sleep.
- Savella (milnacipran) – Works on serotonin and norepinephrine balance.
- Cymbalta (duloxetine) – Antidepressant also used for fibromyalgia pain.
- Lifestyle management – Exercise, stress reduction, and good sleep habits.
Tonmya may become an alternative or additional option once approved.
Tonix Pharmaceuticals & Tonmya (TNXP Stock)
- Tonix Pharmaceuticals (NASDAQ: TNXP) is the company developing Tonmya.
- Many investors track TNXP stock because Tonmya could be a breakthrough treatment for fibromyalgia.
- Positive trial results often increase Tonix stock value.
👉 If you follow pharma stocks, keep an eye on Tonix Pharmaceuticals stock updates.
Tonmya vs Lyrica vs Savella
| Feature | Tonmya (TNX-102 SL) | Lyrica | Savella |
|---|---|---|---|
| Approval Status | Not FDA approved yet | FDA approved | FDA approved |
| Main Action | Improves sleep, reduces pain sensitivity | Reduces nerve pain | Balances serotonin & norepinephrine |
| Common Side Effects | Dry mouth, drowsiness, dizziness | Weight gain, swelling | Nausea, sweating |
| Dosage | Sublingual at bedtime | Oral capsules | Oral tablets |
FAQs
Q1. What is Tonmya used for?
Ans: Tonmya is being developed to treat fibromyalgia, a chronic pain condition.
Q2. Is Tonmya FDA approved?
Ans: No, not yet. It is still in clinical trials.
Q3. When will Tonmya be available?
Ans: Possibly in the next 2–3 years, depending on FDA approval.
Q4. What are the side effects of Tonmya?
Ans: Common side effects include dry mouth, drowsiness, dizziness, and headache.
Q5. Is Tonmya better than Lyrica or Savella?
Ans: Tonmya focuses on improving sleep quality, which indirectly reduces pain. It may be more suitable for patients whose main issue is poor sleep.
Q6. Can I buy Tonmya now?
Ans: No, Tonmya is not available in pharmacies yet.
