After more than 15 years without new treatment options, the FDA has just approved Tonmya for adults living with fibromyalgia. It’s designed to be taken at bedtime and acts by targeting the nonrestorative sleep that often fuels widespread pain and fatigue in fibro.
🧪 In two major trials (RELIEF and RESILIENT), Tonmya helped significantly reduce pain compared to placebo. Patients in the studies were adults aged 18–65 who met the official fibromyalgia criteria and had pain scores of 4 or higher at baseline.
💤 One unique feature? Tonmya works differently from other treatments by targeting sleep-related pathways believed to play a key role in fibromyalgia symptoms.
🚫 Of course, like many meds, Tonmya isn’t perfect. Some people in the trials reported side effects like dry mouth, fatigue, tingling or pain in the mouth, and drowsiness. It also comes with precautions and is not recommended for people with certain heart conditions, thyroid disorders, or liver issues. It's also worth noting that FDA approval in the US does not guarantee approval in the UK. It will need to pass regulatory approval again before it can be prescribed by the NHS. The active ingredient, cyclobenzaprine, was previously available in the UK, but is not currently licensed. It has previously been used to treat fibromyalgia.
🗣️ So let’s open it up to you:
Have you heard of Tonmya before? Would you be willing to try it?
What are your thoughts on targeting sleep quality as a way to treat fibromyalgia pain?
How do you feel about a new medication finally being approved after so long?
The approval was supported by data from 3 double-blind, placebo-controlled trials that included a total of 1474 patients who met the 2016 ACR criteria for diagnosis of fibromyalgia.
Somya.P
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Somya.P
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Last activity on 24/09/2025 at 19:46
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Hello everyone,
After more than 15 years without new treatment options, the FDA has just approved Tonmya for adults living with fibromyalgia. It’s designed to be taken at bedtime and acts by targeting the nonrestorative sleep that often fuels widespread pain and fatigue in fibro.
🧪 In two major trials (RELIEF and RESILIENT), Tonmya helped significantly reduce pain compared to placebo. Patients in the studies were adults aged 18–65 who met the official fibromyalgia criteria and had pain scores of 4 or higher at baseline.
💤 One unique feature? Tonmya works differently from other treatments by targeting sleep-related pathways believed to play a key role in fibromyalgia symptoms.
🚫 Of course, like many meds, Tonmya isn’t perfect. Some people in the trials reported side effects like dry mouth, fatigue, tingling or pain in the mouth, and drowsiness. It also comes with precautions and is not recommended for people with certain heart conditions, thyroid disorders, or liver issues. It's also worth noting that FDA approval in the US does not guarantee approval in the UK. It will need to pass regulatory approval again before it can be prescribed by the NHS. The active ingredient, cyclobenzaprine, was previously available in the UK, but is not currently licensed. It has previously been used to treat fibromyalgia.
🗣️ So let’s open it up to you:
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Looking forward to hearing your thoughts 🧡
Take care,
Somya from the Carenity team 🌼
FDA Greenlights Tonmya for Fibromyalgia Treatment
The approval was supported by data from 3 double-blind, placebo-controlled trials that included a total of 1474 patients who met the 2016 ACR criteria for diagnosis of fibromyalgia.