Personally, I always thought of Fexeril as a fairly “crappy” med.  One time we were at our FL beach condo and I had stressed or pulled a muscle and I went to a local “doc in a box” and he gave me #15 of Flexeril 10 mg, could not persuade him to give me a “better muscle relaxant”. Out of desperation, I had it filled. I took the first dose, and after one hr +/- I got up from the futon I was lying on and took a couple of steps and passed out and hit my head on our (hard)  ceramic flooring.  I was dealing with what is called orthostatic hypotension – when a pt changes positions – standing up from a seated or prone position, and the medication they are taking hinders the pt’s cardiovascular system to adjust the pt’s blood pressure to increase to maintain the pt’s “normal” blood pressure.   Needless to say, the other 14 tablets GOT TOSSED!

Tonmya (cyclobenzaprine HCl) is available as a sublingual tablet in a strength of 2.8mg. The usual dosing regimen for adults with fibromyalgia is:

Initial dose (Days 1–14): 2.8mg (1 sublingual tablet) once daily at bedtime.

Maintenance dose (Day 15 and onward): 5.6mg (2 sublingual tablets) once daily at bedtime, which is the maximum recommended dose.

For geriatric patients or those with mild hepatic impairment, the recommended and maximum dose is 2.8mg once daily at bedtime.

Estimate price for Tonmya 60 tabs/month $150-$200. Since Fibromyalgia is a CHRONIC CONDITION – Insurance/PBM will be ecstatic paying out $1,800-$2,400/month. Since this tab is designed to be placed under the tongue and not in a similar dose to any generic Cyclobenzaprine, I would expect a lot of Prior Authorization BS!

Generic Cyclobenzaprine 10 mg : max dose of 40mg 3xd price via www.single-care.com $7 to $25 for 120 doses, $84 to $300/yr.

FDA Approves First-in-Class Drug for Fibromyalgia

https://www.medscape.com/viewarticle/fda-approves-first-class-drug-fibromyalgia-2025a1000ltm

The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, nonopioid treatment for adults with fibromyalgia, a chronic pain syndrome that affects more than 10 million Americans, roughly 80% of whom are women.

The medication, taken once-daily at bedtime, targets nonrestorative sleep, a root cause of pain, fatigue, and brain fog in fibromyalgia. It’s the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. Tonmya (formerly TNX-102 SL) is expected to be available in the fourth quarter of this year.

In two double-blind, randomized, placebo-controlled, phase 3 trials (RELIEF and RESILIENT) of nearly 1000 patients with fibromyalgia, sublingual cyclobenzaprine significantly reduced daily pain scores compared to placebo at 14 weeks (the primary endpoint).

In addition, a greater percentage of patients using the medication daily at bedtime experienced a clinically meaningful (≥ 30%) improvement in their pain after 3 months, compared to placebo.

Results of the RESILIENT trial were published online on July 8 in Pain Medicine.

A third phase 3 trial (RALLY) of more than 500 patients with fibromyalgia demonstrated greater but nonsignificant treatment effect with sublingual cyclobenzaprine compared to placebo.

Across all three trials, the medication was generally well tolerated with no serious side effects. The most common adverse events were local administration-site reactions including oral discomfort, dry mouth, and canker sores, as well as fatigue and drowsiness.

 

Filed under: General Problems