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

Trial results of new treatment for Fibromyalgia targeting non-restorative sleep

Here I explain new data that was presented at the American College of Rheumatology (ACR) 2021 Convergence showing that a sublingual tablet may reduce central sensitization in people with fibromyalgia who have non-restorative sleep. 

According to the Institute for ChronicPain central sensitization is a condition of the nervous system that is associated with the development and maintenance of chronic pain. When central sensitization occurs, the nervous system goes through a process called wind-up and gets regulated in a persistent state of high reactivity.

Tramadol for Fibromyalgia: My Brutally Honest Research: What Taking & Quitting Tramadol for Fibromyalgia Was Really Like.

Tramadol helped with my pain, but it cost me something much more valuable: my connection with my family. This post is about my personal research into what taking and quitting this drug for Fibromyalgia was really like.

Hi! 

this is all about my experiences with tramadol, both on it and coming off it. You can watch my video on this topic or read the transcript below it. Don't forget to read some of the comments where you will get a wider understanding of tramadol for fibromyalgia from many people.

TRANSCRIPT:

• • My Tramadol Journey: The First Year

  • 
    Tramadol is a centrally acting analgesic which is prescribed for 
  moderately severe pain.  It works in the brain to change both the perception of pain and the response to pain. It is not an opiod but it has some opiate like characteristics. 

When I started taking this medication it was explained to me that it needed to be taken at a regular time once a day and that I would probably have nausea at first for about a week and to make sure to take it with food. I did as prescribed and sure enough I had nausea for one week and then it subsided. 

I used Tramadol regularly for a long time and it did relieve the pain and helped me to lose a little weight but it also helped me to lose interest in life.  The main reason I lost weight was that I had no interest in food or in cooking or in looking after myself. I became like a drug addict but did not realise it. 

The Emotional Wake-Up Call That Made Me Quit

One day after about a year my daughter said she felt like she had lost her mother - she cried and said I was behind a cloud and she could not get to me. This made me realise that I was just sitting on the lounge all day doing nothing and I decided to stop taking Tramadol. 

Why I Went Cold Turkey (and Why You Must Not)

At this point I made a very foolish mistake and decided to go cold turkey. OMG I experienced 7 days of extremely bad withdrawal symptoms the worst of which was the muscle pains and irritability. There was also watering eyes and a runny nose like a bad flu, nausea and sweating and shaking all over. These are all known symptoms if you suddenly stop using this medication but obviously, because of the drug itself, I was not thinking right when I made the decision to just stop taking it without consulting my doctor. He would have told me to come off it slowly in increments. 

In retrospect I could see that the Tramadol was causing major drowsiness in me. When it was completely out of my system I realised that many of the symptoms I had started taking it for had gone - that is the nature of Fibromyalgia, I think, it changes all the time.

Also I feel it is essential to remind you that when taking any medication, especially long term, that you should be made aware of the possible side effects. 

"When choosing between equally effective analgesics, relative safety is important. In the case of tramadol, adverse effects are common and sometimes serious. Tramadol binds weakly to opioid receptors, so at normal doses constipation and respiratory depression occur less frequently than with opioids. However, these effects can, and do, occur at higher doses. Tramadol is metabolised in the liver and excreted by the kidneys, so doses should be adjusted in patients with impaired liver or kidney function, and in the elderly." ~ NPSMEDICINEWISE

 

Understanding Tramadol: Side Effects and Safety Warnings

Side effects associated with use of Tramadol, according to RxList, include the following:

• constipation
• nausea
• dizziness
• vertigo
• headache
• drowsiness
• vomiting
• agitation
• anxiety
• mood swings
• euphoria
• hallucinations
• nervousness
• muscle spasms or stiffness
• indigestion
• weakness
• itching
• diarrhea
• dry mouth
• sweating
• feeling unwell (malaise)
• menopausal symptoms
• rash
• urinary frequency
• urinary retention
• dilation of blood vessels 
• visual disturbances
• abnormal gait
• amnesia
• cognitive dysfunction
• depression

For a complete list please visit RxList

If your medical doctor is using this medicine to treat your pain, your doctor or chemist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Tramadol Include:

• Alvimopan
• Procarbazine
• Rasagiline
• Selegiline

You might also be interested in reading my experiences with Cyclobenzaprine for Fibromyalgia and all the natural treatments I have tried.

There are many interesting comments below that show people's differing experiences with tramadol for fibro. I hope you have time to read some of them. 

Cyclobenzaprine for fibromyalgia

My muscles feel like they are being clenched all the time, especially the muscles in my upper arms, buttocks, thighs and calves. This is a feeling that rarely ever goes away except when I am in warm water at a temperature of 33 to 35 degrees or I am having a massage. 

There are around 650 muscles in the human body! This is a lot of muscles. We may be able to name a few of them such as quadriceps and biceps. But unless we are a medical styudent there are muscles that we have not even heard the names of. 

My muscles sometimes go into spasms like cramps and this is especially bad and immobolizing when the larger muscles are involved. One day I stood up but could not move for about 15 minutes due to pain in my buttocks. This has happened 3 times now. It was quite frightening the first time but now I understand what is happening, at least.

 My muscles are in pain, even as I sit here on a comfortable lounge writing this. My wrists and forearms ache from typing and my legs are just in constant pain. I also get restless leg syndrome quite often where my legs are so irritated I cannot get to sleep. The best way I can describe it is that they feel electrified.

I am explaining all this because I have just heard about a medication used in Fibromyalgia for relaxing the muscles called Cyclobenzaprine. It's brand name is Flexeril and I don't understand why it has never been recommended to me by a doctor as it seems to cover these muscle symptoms. As a matter of fact I have never been prescribed any of the muscle relaxants:

• Cyclobenzaprine (Flexeril)
• Methocarbamol (Robaxin)
• Diazepam (Valium)
• Carisoprodol (Soma)

So on first investigation Cyclobenzaprine gets a good rap:

Cyclobenzaprine has also shown effectiveness in the treatment of fibromyalgia symptoms, with a report of 4.8 patients needing treatment for each (1) patient reporting pain reduction (but no change in fatigue or tender points). Conclusion: Cyclobenzaprine-treated patients were 3 times as likely to report overall improvement and to report moderate reductions in individual symptoms, particularly sleep. Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis

On further investigation many people suffer side effects from Cyclobenzaprine which can range from headache and a tired feeling to dizziness, drowsiness, trouble concentrating, blurred vision, dry mouth or throat, altered sense of taste, nausea, upset stomach and constipation. In elderly patients it can cause confusion, delirium, and cognitive impairment according to the Duke Clinical Research Institute. (PDF)

I would love to hear from you if you have taken any of these muscle relaxants to help your muscle pain or for any other reasons.

Neurontin and Lyrica for Fibromyalgia

In the past, when I first was diagnosed with Fibro, I took many different medications to try and reduce my symptoms of pain and fatigue and numbness and tingling.  Neurontin and Lyrica were just 2 of the treatments that my rheumatologist prescribed at different times. 

I have put them together, in this post, because I now know, that they are both anticonvulsant drugs or anti-seizure drugs. Neurontin is also called gabapentin and Lyrica is also called pregabalin. 

Neurontin (gabapentin) was made to treat epilepsy but is now used to treat fibromyalgia and other types of chronic pain. It is used to treat neuropathic pain which I had in the form of the tingling and numbness in my fingers, hands, toes and feet. 

It is not possible to know whether Neurontin will help you or not before you start taking it. Apparently it helps 4 out of 10 people reduce their pain by half according to a clinical trial run on 5633 people with Fibromyalgia. There are a few side effects and I experienced one of them which was dizziness. 

Now dizziness may seem very slight to some people, as a side effect, but it made life very difficult, especially driving.  I also experienced nausea, even when taking the tablet with food. The good news was that the tingling and numbness did stop initially, which was very exciting after living with it for many years but after 2 weeks it came back again. The suggestion was to increase the dose but this also increased the dizziness and the nausea. By this stage I had gained weight and felt that my fibro fog was more constant.  In the end I chose to stop taking it because the side effects seemed to outweigh the benefits.

Gabapentin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• tiredness or weakness
• dizziness
• headache
• uncontrollable shaking of a part of your body
• double or blurred vision
• unsteadiness
• anxiety
• memory problems
• strange or unusual thoughts
• unwanted eye movements
• nausea
• vomiting
• heartburn
• diarrhea
• dry mouth
• constipation
• increased appetite
• weight gain
• swelling of the hands, feet, ankles, or lower legs
• back or joint pain
• fever
• runny nose, sneezing, cough, sore throat, or flu-like symptoms
• ear pain
• red, itchy eyes (sometimes with swelling or discharge)

Both Neurontin and Lyrica are antiepileptic medications and overall they are quite similar but have a few differences: absorption of Neurontin happens in the small intestines and absorption of Lyrica happens in the small intestine and in the ascending colon as well and is more quickly absorbed.  

Lyrica (pregabalin) is also a drug that targets nerve pain and I remember on the first night I took it having no pain and an extremely good sleep. This was exceptional as I had been in pain every day for years and also having difficulties falling asleep and staying asleep. Little did I know that the daytime drowsiness would not go away and the lack of pain only last 3 days. They were 3 days of bliss though and I remember going around the house saying "the absence of pain is bliss." Sadly the dose had to increase, the drowsiness did not subside and I started to get blurry vision all of which meant Lyrica was no longer my best friend. Once again I decided to stop a medication after consulting my specialist.

Pregabalin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• dizziness
• headache
• dry mouth
• nausea
• vomiting
• constipation
• gas
• bloating
• ''high'' or elevated mood
• speech problems
• difficulty concentrating or paying attention
• confusion
• difficulty remembering or forgetfulness
• anxiety
• lack of coordination
• loss of balance or unsteadiness
• uncontrollable shaking or jerking of a part of the body
• muscle twitching
• weakness
• increased appetite
• weight gain
• back pain

SOURCES: MedlinePlus for side effects

YOU May also be interested in these articles:
Duloxetine in patients with Fibro 
Opoids and Fibromyalgia

Fibromyalgia medications list

Medications used for Fibromyalgia

Medications used for Fibromyalgia

There is no best or safest treatment for fibromyalgia.

It is hard to predict what will be helpful for each person.

In some people, a combination of medicines, may be more effective.

Here is a list of the types of medications most often used to treat fibromyalgia:

1. Analgesics: commonly called pain killers. They include aspirin, acetaminophen, ibuprofen, nonsteroidal anti-inflammatories (NSAIDs), corticosteroid anti-inflammatories like prednisone and dexamethasone, opioids such as codeine, oxycodone, morphine and fentanyl and tramadol, a narcotic-like opiate agonist.
2. Anti-anxiety Medications
3. Antidepressants including including amitriptyline, fluoxetine and duloxetine.
4. Anti-convulsants including gabapentin (Neurontin) and pregabalin (Lyrica)
5. Sleep Modifiers
6. Muscle Relaxants such as cyclobenzaprine.

In some people, a combination of medicines, may be more effective.

Medication is just one of options to treat fibromyalgia and many people find some relief from alternative treatments like massage, Ayurvedic Treatment, movement therapies (such as Pilates, the Feldenkrais method and yoga) homeopathy and acupuncture.

You may be interested in More indepth information on medications.

Duloxetine in Patients With Fibromyalgia

This article is about Duloxetine, which is most commonly called Cymbalta, for people with fibromyalgia. It includes information on research into how you know if it may be effective for you and some commonly asked questions about this drug. 

RESEARCH

"Early improvements in pain during the first two weeks of treatment with duloxetine were highly predictive of response or nonresponse after three months of treatment." according to the researchers.

What does this mean??

It means there are signs when you first start taking this drug that show if it is going to help your fibromyalgia or not. This is from a study published in the October 2011 issue of the Journal of Pain: the official journal of the American Pain Society.

Duloxetine, also known as Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela, is a long-acting capsule used to treat depression or generalized anxiety disorder or the pain of diabetic neuropathy or fibromyalgia, or ongoing bone or muscle pain.

Duloxetine is meant to be better than many other medications for the treatment of fibromyalgia as it does not contain as many substances that can cause adverse reactions. Its effectiveness in pain relief is believed to be due to its changing of the nociception system. (pain reception).

Clinical trials have confirmed it gives pain relief, reduces fatigue, and improves physical and mental function. In 2014 researchers, Lunn MPT, Hughes RAC, Wiffen PJ, studied all the published scientific literature on duloxetine and found eight separate trials that tested the effect of duloxetine on painful diabetic neuropathy and six on the pain of fibromyalgia. they concluded that 'The usual dose of duloxetine is 60 mg. At this dose, there was moderate quality evidence that duloxetine reduced pain in both painful diabetic peripheral neuropathy and fibromyalgia.'

GENERAL INFORMATION ABOUT DULOXETINE
Duloxetine comes as a delayed-release capsule which means it releases the medication in the intestine. This is so it is absorbed better.  When duloxetine is used to treat generalized anxiety disorder, the pain of diabetic neuropathy, fibromyalgia, or ongoing bone or muscle pain, it is usually taken once a day with or without food. 

Is duloxetine FDA approved for fibromyalgia?

In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain and the treatment of major depressive disorder and generalized anxiety disorder, all in adults age 18 years and older. (LILLY)

Can duloxetine help with fibromyalgia pain?

In clinical trials, Cymbalta significantly and quickly improved pain. More than half of the patients with fibromyalgia said they felt much better within one week. Pain relief may be greater in patients who also have existing depression, although those without depression also have a significant improvement in symptoms. (WebMD)

What are the most common side effects when taking duloxetine (Cymbalta)?

Constipation, dry mouth, and nausea are the most common side effects.
Does duloxetine interact with other medications?
Blood thinners and non-steroidal anti-inflammatory drugs and some migraine medications are just some of the drugs that interact badly with duloxetine. Make sure your doctor and pharmacist know what other drugs, vitamins, and herbs you are taking. As examples, St John's wort and some cough medicines can cause problems. More information on drug interactions can be found here.

Can duloxetine help young patients with Fibromyalgia?

One study has found that duloxetine was not effective in teenagers with fibromyalgia. You can read the report here on this site.
 SOURCES:

PubMed
MedlinePlus

Cochrane

Lilly

WebMD

Have you taken this drug and do you agree with this report? 

Did this medication - Duloxetine - help you?

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SOURCES:
PubMed
MedlinePlus

Have you taken this drug and do you agree with this report? Did this medication - Duloxetine - help you?

An effective treatment for fibromyalgia?

Dr. R. Paul St. Amand is the Assistant Clinical Professor Medicine, Endocrinology Department at UCLA, USA and he is continuing his treatment for fibromyalgia called the Guaifenesin Protocol.

He says Fibromyalgia, or "Fibrositis" as it was then called, was first described in 1843 as a type of rheumatism "with painful hard places."

I have never heard this description of the "painful hard places" before but definitely have them in my neck, shoulders and right thigh.

So what is this treatment and what is guaifenesin?
It is a uricosuric, which means it increases the excretion of uric acid from the blood serum into the urine. It is believed to cure fibromyalgia by removing excess phosphate from the body.

The Guaifenesin Protocol
"We begin patients with 300 milligrams of long acting guaifenesin twice a day for one week. Feeling distinctly worse suggests adequate dosage and patients remain on that amount. This suffices for only 20 percent of patients; if symptoms do not worsen, we increase to 600 mg. twice daily. Reversal begins for 80 percent of patients at one of these two levels leaving 20 percent who will need more. "

This is from Dr Amand's website - it sounds a bit complex to, so if I am going to try it I will need a doctor who knows about this treatment and also to be really believing that is going to work.

Our treatment is not for those lacking courage. It calls for patient skills and, hopefully, physician assistance. Remember, reversal of the disease reproduces past symptoms and may cause new or long-forgotten ones to re-surface. The intensity of these early cycles often causes concern during the initial weeks of treatment. Such symptoms are not guaifenesin side effects.

Book to read: What Your Doctor May Not Tell You About Fibromyalgia: The Revolutionary Treatment That Can Reverse the Disease by R. Paul St. Amand, M.D. and Claudia Craig Marek, published by Warner Books.

Below is a Body Map with a Symptom Checklist which you can download...

Get this Printable Body Map with Symptom Checklist from Dr Amand's site.

Read my updated post on The Guaifenesin Protocol for fibromyalgia

I am not recommending this or any other treatment or product - I am writing about it to inform you of a possible treatment to check out. I am an Amazon affiliate not an affiliate of Dr Amand. As an Amazon affiliate I earn from qualifying purchases, at no extra cost to you and thank you.