Here is and excerpt from my upcoming 6th edition Treating and Beating Fibromyalgia (October 2026) and a short video about new fibromyalgia drug Tonmya  

You Can’t Drug Your Way Out of Fibromyalgia

Not to be controversial but the reality is most over the counter and almost all prescription drugs, merely mask symptoms. Drugs almost rarely deal with the underlying causes or reasons why these problems exist. And they often create new health problems from their side effects. This is like trying to mop the wet kitchen floor, repeatedly every time it rains, while ignoring the leaky roof! Fix the cause (hole in the roof) and the symptoms (wet kitchen floor) disappear, for good.

Drugs can be helpful, even lifesaving, but too many, too long, can create additional health problems.

Thank goodness we have that option when needed. However, it’s better to fix the leaky roof than continue mopping the wet floor every time it rains. Correcting underlying causes is always preferable when possible.

Treating Symptoms Not Causes Often Leads to More Symptoms

Americans filled 4.3 billion prescriptions and doled out nearly $800 billion on medicine in 2024, according to new data from the IMS Institute for Healthcare Informatics. Ninety-eight billion was spent out of pocket. This is a twenty five percent increase from five years ago. 

As reported in the Journal of the American Medical Association, over 113,000 Americans die each year from the negative effects of prescription medications. Not to point fingers, because drugs are an essential part of modern health care, but they should be judiciously prescribed and taken with eyes wide open.

Treating high blood pressure with lifelong drug therapy is great for drug companies but often a disaster for the patient, in part due to their side effects. The good news is that high blood pressure is usually not a disease, but a symptom of something else like excess weight and a sedentary lifestyle. This means that you can often “cure” it by eating healthy, losing weight and exercising daily.

The same is true for most type 2 diabetes cases. High blood sugar is a symptom, not a disease, and can usually be lowered with a healthy diet, losing weight and exercise rather than medications.

It’s important to realize that your drug or drugs may be causing or contributing to some or all your symptoms.

Ambien, for example, can cause brain fog, diffuse achy muscle pain, lethargy, fatigue, anxiety, depression, restless leg syndrome, balance issues, poor memory, mood disorders and even flu-like symptoms.

Sounds like FMS, doesn’t it?

Moreover, they deplete essential nutrients that the body needs to properly function, but it can take weeks, months, or even years for the drug to fully deplete the nutrient and for you to see the side effects surface.

I spend a great deal of time with my new patients reviewing and discussing their current drugs—how they interact with each other, and the potential side effects. I often find that by asking the right questions, I can help the patient realize that her symptoms began or worsened soon after the drug treatment began, and we can course-correct.

The newest FDA approved drug for fibromyalgia is known as Tonmya.

What About Tonmya

The first “new” drug specifically for fibromyalgia in fifteen years, Tonix Pharmaceuticals’ product Tonmya (previously TNX‑102 SL) is a sublingual form of the muscle relaxant cyclobenzaprine which has been available for years.

Cyclobenzaprine is a muscle relaxant chemically similar to the antidepressant Elavil. It is quite sedating and does promote deep, restorative sleep; however, it also is associated with early-morning hangover, daytime fatigue, and depression.

A Drugs.com review notes that the sublingual formulation “offers advantages over traditional oral formulations by enabling rapid absorption into the bloodstream, bypassing the liver for improved metabolism.

Tonmya was evaluated in two phase‑III trials (RELIEF and RESILIENT). In the RELIEF trial (503 participants with fibromyalgia), patients started with 2.8 mg nightly and titrated to 5.6 mg; the reduction in average daily pain at week 14 was −1.9 on a 10‑point scale versus −1.5 with placebo – a statistically significant but clinically modest difference of 0.4 points.

Evidence for cyclobenzaprine in fibromyalgia is weak: a comprehensive review concluded that most patients do not benefit and that any perceived relief results largely from sedation with a high rate of adverse events. The phase‑III trial of Tonmya produced a difference of only 0.4 points on a 10‑point pain scale, similar to placebo‑controlled trials of low‑dose oral cyclobenzaprine.

Low‑dose oral cyclobenzaprine (2–5 mg at bedtime) is inexpensive, widely available and already minimizes sedation; there is no compelling evidence that a 2.8 mg sublingual tablet offers superior efficacy or safety.

Without insurance regular cyclobenzaprine costs $55 for thirty 10 mg tablets.

The cash retail price for a monthly supply of Tonmya (typically 60 tablets for a 30-day supply) ranges from $1,800 to $2,250.

Reducing pain by .4 points on a 10point scale isn’t worth the all the hype and cost and is sure to be another disappointment in the fibromyalgia community.

Neurontin (gabapentin) and Lyrica (pregabalin) are two anticonvulsant and analgesic medications originally prescribed for the treatment of epilepsy. Neurontin was originally licensed in the United States and Canada in December 1993 for use as an adjuvant medication to treat seizures and epilepsy. Lyrica on the other hand, is a much newer drug that received approval for use in the treatment of epilepsy, diabetic neuropathic pain, and post herpetic neuralgia in 2005. It is a much more powerful version of gabapentin.

In June 2007, Lyrica was approved as a treatment for fibromyalgia. The mechanism of action of these two drugs is still partially unknown to medical science, but they’re thought to be able to reduce the production of some neurotransmitters in the brain that are deemed responsible for pain and convulsions.

According to the US Food and Drug Administration (FDA), these antiepileptic drugs (AEDs) do in fact “increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.”

Another serious side effect of antiepileptic drugs was revealed by researchers from Stanford University School of Medicine. They found that AEDs reduces our brain’s natural ability to form of new brain synapses, also known as “neuroplasticity.” As our brain’s ability to grow and evolve prevents all age-related cognitive decline, taking such drugs can pose a significant risk to our mental faculties moving forward.

Brain fog or “fibro fog” is already a major concern for most fibromyalgia patients. These drugs may only make matters worse.

Lyrica and Fibromyalgia

Lyrica (known generically as pregabalin) was one of the first prescription medication approved to treat fibromyalgia.

Lyrica affects the perception of pain by binding to receptors in the brain and spinal cord to reduce activity in the central nervous system.

While Lyrica is actually very similar to Neurontin (the two compounds share similar mechanisms of action), it supposedly requires lower doses to be as effective. Unfortunately, they are both associated with all the same unpleasant side effects.

Some have said that Lyrica does not work well enough to have warranted its FDA approval.

Multiple randomized trials and Cochrane reviews show that 300 mg to 450 mg daily reduces pain. Roughly 1 in 10 patients achieve substantial relief (cutting pain in half) compared to placebo, while 2 to 3 out of 10 experience moderate improvements.

According to The New York Times, patients in clinical trials taking Lyrica reported that their pain fell on average about two points on a ten-point scale, compared with one point for patients taking a placebo. Not a big effect, to say the least. About 30 percent of patients did report that their pain decreased by at least half, compared with 15 percent taking placebos. While a 50 percent reduction in pain is impressive, remember that it occurred in only three out of ten patients who took Lyrica. And half of those could have been under the placebo effect.

In 2004, Lyrica was reviewed by the FDA as a remedy for diabetic nerve pain. The reviewers recommended against approving the drug, citing its side effects including weight gain, swelling, dizziness and sleepiness. According to the New York Times, in twelve-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time.

The FDA ignored the advice of Lyrica reviewers and approved it anyway. In June 2007, Pfizer, the maker of Lyrica, then asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, to which the agency also agreed.

In 2018 Pfizer spent over $450 million dollars promoting Lyrica. That same year, The New York Times reported that the worldwide sales of Lyrica reached $4.9 billion. 

The following outlines some of the “common” side effects of Lyrica and Neurontin:

• Weight gain – some gain as much as forty pounds the first year!

• Blurred vision

• Body tremors

• Possible insomnia – complicating an already major problem of fibromyalgia

• Gastrointestinal difficulties, such as diarrhea and constipation, and other IBS-like symptoms, which leads some to believe they have IBS.

• Mild to severe headaches

• Nausea

• Swelling in hands

• Dry mouth

• Swelling in ankles

• Dizziness

• Drowsiness

• Possible fainting

• Diffuse achy muscle pain

• Brain Fog- a common complaint for many with fibro

• Anxiety

• Depression

• Fatigue

• Balance issues

I find that few of my patients on these meds are benefitting from their use. They have serious side effects and should not be taken unless it is the last resort!

Most patients can slowly wean off these medications with their doctor’s help, with no problems.

Still, for those who can’t get their pain under control any other way, Lyrica is certainly an option. The important thing is to be aware of the potential risks. Here are excerpts from just a couple of emails I have received from people who tried Lyrica and reported to me about it.

Lisa T.

“When Lyrica was approved, I was the first in my doctor’s practice, at the door, ready to try it. Unfortunately, the drug tried me. One 25-miligram dose and…I couldn’t think, my vision was severely blurred, my speech slurred to the point my husband determined I’d had a stroke.

I couldn’t walk…after notifying the doctor, he assured my husband. I have absolutely NO memory of anything thirty minutes after taking that pill…I looked my daughter directly in the face from about twelve inches away and had no idea who she was. According to [my husband and daughter], I had absolutely no effect [emotions] and didn’t say a word… They took me home, put me to bed, and I stayed there for two days, barely eating and sleeping between waking in horrible pain… So it only made me worse, but I’m grateful it does help a few of us, and I’m grateful most of all for the commercials that validate that we’re out here, we’re normal people, and we are in pain.”

Maria R.

“The drug helped me sleep deeply, although I was never really refreshed by my sleep. Even on this low dose, my pain did not improve but slowly worsened over the year. I developed incredible muscle stiffness; the muscles in my back often felt like they were set in concrete. I could not bend forward an inch upon getting up in the morning. Eventually, I felt that perhaps what I thought were worsening fibromyalgia symptoms were Lyrica side effects. I decided to give myself a birthday present and stop taking Lyrica. This was a terrible mistake. In my enthusiasm, I neglected to ask my physician how to discontinue Lyrica. I just stopped. Not good. First 24 hours, nothing. Just a normal day except that I got out of bed and could instantly touch my toes again. I was delighted! During the second 24 hours, I began to feel uneasy and “flu like.” On the third night after discontinuing the drug, I felt like I had walked off a cliff. I experienced high agitation and anxiety—was totally unable to rest or sleep. My heart pounded as if it would leap from my body. My chest was tight, and I felt unable to breathe. I hurt from head to toe, experienced awful tingling in my legs, arms, and hands. The itching was terrible, especially around my neck and shoulders. I was nauseated and completely unable to eat. These symptoms continued for two weeks. I made one trip to the ER, sure that I must be having a heart attack. I was terrified. The ER doctor was confident that it was Lyrica, saying that it was a hard drug to withdraw from. I’ll vouch for that! I would never encourage anyone to take this medication. I am almost two months past this awful episode in my life, but I am still struggling with the aftermath.”

Based on my experience of treating hundreds of patients taking Lyrica, I believe it to be worthless for 90 percent of my patients. Most of my patients taking it can’t stay on it due to side effects. The others who attempt to stay on the drug usually find that the drug, once weaned off, is never missed—it did nothing! You should know I’ve had numerous patients wean off the drug and realize that their pain had improved. Yes, one of the many potential side effects associated with Lyrica is chronic pain.

Cymbalta and Savella

The second and third drugs approved for fibromyalgia Cymbalta (duloxetine) and Savella (milnacipran), are antidepressants.

A study evaluating these two drugs for fibromyalgia, shows that these drugs may be more harmful than helpful. Among fibromyalgia patients taking either of the two commonly prescribed drugs to reduce pain, 22 percent reported substantial improvement while 21 percent had to quit the regimen due to unpleasant side effects, according to a review in The Cochrane Library.

The authors reviewed ten high-quality studies following more than 6,000 adults who received duloxetine (Cymbalta), milnacipran (Savella), or a placebo for up to six months.

“This is a very important study,” said Fred Wolfe, MD, of the National Data Bank for Rheumatic Diseases. “There’s an enormous amount of advertising suggesting that these drugs really help, whereas the research data show that the improvement is really minimal.”

Treatment with drugs alone “should be discouraged,” the reviewers added. Instead, they recommend a multifaceted treatment approach including medications for those who find them helpful, exercises to improve mobility, and psychological counseling to improve coping skills.

I applaud the authors’ recommendations; however, “psychological counseling” should never be interpreted to mean that the patient is lazy, crazy, or a hypochondriac. Nothing could be further from the truth, and I’d suggest this recommendation does more harm than good. Similarly, exercise for a fibro patient, especially those with severe symptoms, only causes flares, more pain, and fatigue until the underlying causes are addressed.

Learning to cope with chronic pain or becoming more limber have their place, but they offer little in the way of correcting fibromyalgia at its core.

Savella and Cymbalta may be helpful, certainly safer than Lyrica, but again, no one suffers from an antidepressant deficiency.

The approval of Savella was based on two clinical trials involving 2,084 fibromyalgia patients (1,460 on Savella and 624 on placebo). About 25 percent of people taking Savella had a positive response, considerably better than the 13 percent who had a positive response to a placebo. However, while the makers of Savella will be sure to tout this, they won’t tell you that the drug failed to help 1,095 of the 1,460 participants in the study.

There are no studies directly comparing Savella to Cymbalta, although it’s likely that because of their similar mechanisms of action, they would be similar in effectiveness. Both drugs are antidepressants known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). They are supposed to help a person use her own serotonin and norepinephrine more effectively by blocking the brain’s normal removal of these chemicals from its synapses.

Common side effects of prescription antidepressants may include anxiety, depression, headache, muscle pain, chest pain, nervousness, sleeplessness, drowsiness, weakness, changes in sex drive, tremors, dry mouth, irritated stomach, loss of appetite, dizziness, nausea, rash, itching, weight gain, diarrhea, impotence, hair loss, dry skin, chest pain, bronchitis, abnormal heartbeat, twitching, anemia, low blood sugar, and low thyroid.

All antidepressants are partially or wholly broken down in the liver, and this can create liver dysfunction in patients with a sluggish liver. Common in chronically ill patients.

Harvard Medical School’s Dr. Joseph Glenmullen has reported on the many dreadful side effects associated with conventional antidepressant medications.

His report included neurological disorders, sexual dysfunction (in up to 60 percent of users), debilitating withdrawal symptoms (including hallucinations, electric shock–like sensations, dizziness, nausea, and anxiety), and decreased effectiveness in about 35 percent of long-term users.

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