The introduction is also posted on Spotify as a podcast by “Gerry at The Health Equation”

You can search Spotify for “Gerry at The Health Equation”

Or use the link below

https://podcasters.spotify.com/pod/show/gerrygaj

Below is the specific link

Gerry Gajadharsingh writes:

“Chronic Fatigue Syndrome (CFS) Is often associated with fibromyalgia, and with a lot of similarities to so-called long Covid syndrome, it is a complex condition.

Fibromyalgia is what researchers call a nociplastic pain condition — the nervous system becomes hypersensitive, leading to widespread pain, poor sleep, fatigue, and brain fog. Until now, treatment options have been limited, and many patients cycle through multiple medications without lasting relief.

The research below focuses on a new drug Tonmya (cyclobenzaprine hydrochloride sublingual tablets), which when released in the USA, is estimated to cost approximately £200 per month. There is no “Gold standard” medication for CFS although it’s common to see a combination of Pregabalin (membrane stabiliser/anticonvulsant) and Duloxitine (SNRI serotonin-noradrenaline reuptake inhibitor, anti-depressant) used, as well as drugs such as amitriptyline (tri cyclic antidepressant).

The challenge with something like CFS/ fibromyalgia, is that patients want validation for their symptoms and an explanation/mechanism for their condition, with conventional mention to date, struggling to find evidence of overt pathology, and therefore struggles to offer appropriate and successful treatment.

Chronic pain costs Europe an estimated €12 billion annually—but the deeper cost is human.

Too many patients fall through the cracks when the link between stress and pain is overlooked in early care. Despite strong evidence supporting a biopsychosocial approach, structural models still dominate initial consultations.

We must shift the narrative:
✔️ Pain does not always equal harm
✔️ The nervous system can learn pain
✔️ Chronic stress is a powerful amplifier
✔️ Movement is often safe—and essential

It’s time to embrace an integrated model that honours both the science and the human experience of pain.

The interesting thing about this particular new drug, is that the positive impact on pain only causes a 30% reduction in pain, which doesn’t sound like much, but may well be helpful as part of a more integrated approach to help deal with this chronic and complex condition.

As with many complex conditions, the mechanism behind symptoms is often multifactorial and treatment needs to be directed at these multiple factors rather than just continuing to hope that one magical medication will suddenly take away all the symptoms of CFS.”

For the first time in over 15 years, the FDA has approved a new medication for fibromyalgia, a chronic pain syndrome that affects more than 10 million Americans, most of them women. The newly approved treatment is Tonmya (cyclobenzaprine hydrochloride sublingual tablets), developed by Tonix Pharmaceuticals.

Unlike traditional painkillers, Tonmya is a non-opioid, under-the-tongue medication designed to be taken once daily at bedtime. Its main target is nonrestorative sleep — poor-quality sleep that leaves patients fatigued and foggy the next day, and which plays a key role in worsening fibromyalgia symptoms.

What the Research Shows

Tonmya has been studied in three large, phase 3 clinical trials — RELIEF, RESILIENT, and RALLY — involving nearly 1,500 people with fibromyalgia.

  • In the two pivotal trials (RELIEF and RESILIENT), patients taking Tonmya had greater reductions in daily pain scores compared to those taking placebo at 14 weeks.
  • A higher percentage of patients achieved a clinically meaningful improvement in pain (at least 30% reduction) after 3 months on the medication.
  • Benefits went beyond pain relief — improvements were also seen in sleep, fatigue, and daily functioning, which are core challenges in fibromyalgia.
  • The third trial (RALLY) also suggested a benefit, though the results did not reach statistical significance.

Across all studies, most people were able to tolerate the medication well. Around 8 in 10 patients in both the Tonmya and placebo groups finished the trials. The most common side effects were mild and included oral discomfort, dry mouth, canker sores, fatigue, and drowsiness. Importantly, no serious safety concerns were identified.

What Do the Results Mean in Plain Language?

Here’s a simplified breakdown of the findings:

  • Both groups improved, but people taking Tonmya had slightly more pain relief.
  • On average, those on Tonmya reported their pain dropped by 1.8 points on a 0–10 scale, compared with 1.2 points on placebo.
  • That’s about an extra half-point of pain relief, which is a real difference but not a dramatic one.
  • The medication also improved sleep quality, energy, and daily functioning — benefits that may matter just as much as pain relief.

In short: Tonmya isn’t a cure and won’t take pain away completely. But for some people, it may offer a modest boost in pain control plus meaningful improvements in sleep and wellbeing.

A Patient-Friendly Takeaway

“This new bedtime treatment helped people with fibromyalgia feel a little less pain, sleep better, and cope better day to day. Most people tolerated it without major problems. The pain relief alone is fairly modest, but when combined with better sleep and less fatigue, it may make life a bit more manageable.”

Why This Matters

The approval of Tonmya marks the first new FDA-approved fibromyalgia therapy in more than a decade, offering patients and clinicians another tool in managing this complex condition.

Tonmya is expected to become available in the fourth quarter of 2025.