Thursday

Tonmya for Fibromyalgia: What You Need to Know

 FAQ for the Fibromyalgia Community

🟣 What is Tonmya?

Tonmya is a new FDA-approved medication for adults with fibromyalgia. It’s a non-opioid, once-daily tablet that dissolves under the tongue at bedtime, designed to reduce pain and improve sleep.

🟣 How does Tonmya work?

Tonmya targets pain and nonrestorative sleep, two core symptoms of fibromyalgia. It’s absorbed quickly through the mouth’s mucosa, bypassing the liver’s first-pass metabolism. This helps reduce side effects and allows the medication to act faster.

🟣 What makes Tonmya different from other treatments?

  • First new FDA-approved fibromyalgia drug in over 15 years

  • Sublingual delivery (under the tongue) for faster absorption

  • Lower risk of long-lasting metabolites that can cause side effects

  • Designed to improve sleep quality, which is often disrupted in fibromyalgia

🟣 How effective is it?

In clinical trials with over 1,400 participants:

  • Tonmya significantly reduced daily pain scores compared to placebo

  • Many patients saw a ≥30% improvement in pain after 3 months

  • Improvements were seen as early as week one

🟣 What are the common side effects?

Reported side effects include:

  • Mouth numbness or tingling

  • Dry mouth

  • Drowsiness

  • Fatigue

  • Canker sores These were generally mild and occurred in a small percentage of participants.

🟣 Is Tonmya safe for everyone?

Tonmya is not recommended for:

  • People allergic to cyclobenzaprine

  • Those taking MAO inhibitors or within 14 days of stopping them

  • People who are pregnant or planning pregnancy, due to potential risks shown in animal studies

🟣 When will Tonmya be available?

Tonmya is expected to be commercially available in the U.S. by late 2025.

🟣 Can I ask my doctor about it now?

Yes. While it’s not yet on pharmacy shelves, you can start the conversation with your healthcare provider. They can help you track availability and assess whether Tonmya might be a good fit for your treatment plan.

Read more in-depth information about Tonmya on this blog.

  1. Drugs.com
  2. AFSA
  3. TONIX pdf


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