Description

What is Tonmya?

Tonmya is a new non-opioid prescription treatment for fibromyalgia use to help reduce pain, improve sleep quality, and relieve fatigue. Tonmya is taken once daily at bedtime and has been shown to decrease fibromyalgia pain as early as the first week of treatment, with continues improvements over time.

<p><p>Also , Tonmya (cyclobenzaprine HCl) is a sublingual tablet that dissolves under the tongue, delivering rapid and long-lasting pain relief with an acceptable safety profile.

More so,  Tonmya’s FDA approval was granted on August 15, 2025, as a first-line treatment for adults with fibromyalgia. FDA approval was base on results from clinical trials RELIEF (NCT04172831), RESILIENT (NCT05273749), which demonstrated significant reductions in pain and improvements in sleep at 14 weeks. Substantial pain reduction was achieve as early as week one and continue to improve throughout the RESILIENT study.

Moreso , Tonmya is thought to work by its potent binding and antagonist activities at four different post-synaptic neuroreceptor . Subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. The sublingual formulation of cyclobenzaprine offers advantages over traditional oral formulations by enabling rapid absorption into the bloodstream and bypassing first-pass hepatic metabolism. This reduces the formation of norcyclobenzaprine, a long half-life active metabolite, which may improve tolerability.

Tonmya side effects

Common Tonmya side effects

<p>The most common Tonmya side effects are oral pain, fatigue and dry mouth . numbness in the mouth (oral hypoesthesia), oral discomfort, abnormal product taste, drowsiness, canker sores, mouth tingling, pricking, or burning.

Serious side effects

Tonmya may have serious side effects, including:

<strong>Serious allergic reaction: Tell your health care provider right away if you experience symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of the face or tongue, or itching.

Embryofetal Toxicity. If Tonmya is use two weeks before conception and through the first trimester of pregnancy, it may cause neural tube defects, base on animal data. Females of reproductive potential should be advise of the potential risk . Also advise to use effective contraception during treatment and for two weeks after the final dose.

Serotonin Syndrome:

Potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when use in combination with other drugs . Such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.

Tricyclic Antidepressant-like Adverse Reactions:

Tricyclic Antidepressant (TCAs) have been reported to produce arrhythmias . Also, sinus tachycardia and prolongation of the conduction time leading to myocardial infarction and stroke. Patient should stop taking Tonmya and notify their health care provider right away if they experience symptoms of arrhythmias or tachycardia.
TCAs lower the seizure threshold and are associated with serious CNS reactions. If clinically significant CNS symptoms develop, consider discontinuation of Tonmya.

<strong>Atropine-like Adverse Reactions: This medicine should be use with caution in patients with a history of urinary retention, angle-closure glaucoma, increases intraocular pressure, and in patients taking anticholinergic medications.