Tonmya

Generic name: cyclobenzaprine  [ sye-kloe-BEN-za-preen ]
Dosage form: sublingual tablet (2.8 mg)
Drug class: Skeletal muscle relaxants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 16, 2025.

What is Tonmya?

Tonmya is a new non-opioid prescription treatment for fibromyalgia used 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 continued improvements over time. 

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

Tonmya's FDA approval was granted on August 15, 2025, as a first-line treatment for adults with fibromyalgia. FDA approval was based 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 achieved as early as week one and continued to improve throughout the RESILIENT study. 

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

The most common Tonmya side effects are oral pain, fatigue, 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:

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 used two weeks before conception and through the first trimester of pregnancy, it may cause neural tube defects, based on animal data. Females of reproductive potential should be advised of the potential risk and advised 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 used 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, sinus tachycardia, 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.

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

CNS Depression and Risk of Operating a Motor Vehicle or Hazardous Machinery: Patients using this medicine should not operate a motor vehicle or other dangerous machinery until they are reasonably certain that Tonmya will not affect their ability to engage in such activities.

Oral Mucosal Adverse Reactions:  This medicine may cause severe oral side effects. Patients should moisten the mouth with sips of water before administration of Tonmya to reduce the risk of oral sensory changes (hypoesthesia). Patients should report severe oral side effects to their health care provider.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Warning

Tonmya may enhance the impairment effects of alcohol. These effects may also be seen if Tonmya is taken with other CNS depressants.

Patients should not operate a motor vehicle or other dangerous machinery until they are reasonably certain that Tonmya therapy will not adversely affect their ability to engage in such activities.

Before taking this medicine

You should not take Tonmya if you are:

• Allergic to the active ingredient cyclobenzaprine or any inactive ingredients
• Taking medicines called monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation
• During the acute recovery phase of myocardial infarction (heart attack) and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
• Hyperthyroidism (overactive thyroid)

Before taking Tonmya, tell your doctor if you have: 

• Liver impairment as it is not recommended for patients with moderate or severe liver impairment

Pregnancy

Tonmya may cause neural tube defects when used two weeks before conception and through the first trimester of pregnancy. Because neural tube development occurs early in pregnancy, often before pregnancy is recognized, females of reproductive potential should be made aware of the potential risk to the fetus and should avoid use of Tonmya two weeks prior to conception and through the first trimester of pregnancy. Females of reproductive potential should be advised to use effective contraception during Tonmya treatment and for two weeks after the final dose. You may be required to do a pregnancy test before starting this medicine to confirm that you are not pregnant.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed while using Tonmya. It is not known whether this cyclobenzaprine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

How should I take Tonmya?

Tonmya is a sublingual tablet taken once daily at bedtime. The tablet or tablets should be placed under the tongue and allowed to dissolve.

Tonmya instructions

• Administer after brushing teeth and finishing other oral care, and ensure a moist mouth/sublingual area
• by drinking a few sips of water before administration.
• Place the sublingual tablet(s) under the tongue until dissolved.
• Do not swallow whole, cut, crush, or chew the tablet.
• Do not eat or drink for at least 15 minutes after the tablet(s) have completely dissolved.
• You should try and avoid any hot, cold, or acidic beverages until the morning.
• Avoid talking for at least 5 minutes after administration of the tablet(s).

Tonmya dosing information

The recommended starting dose of Tonmya is 1 sublingual tablet once daily at bedtime for the first 2 weeks, followed by 2 sublingual tablets once daily at bedtime thereafter.

Recommended Tonmya Dosage

• Initial dose (Days 1–14): 2.8 mg (1 sublingual tablet) once daily at bedtime.
• Maintenance dose (Day 15 and onward): 5.6 mg (2 sublingual tablets) once daily at bedtime.
• Maximum recommended dose: 5.6 mg once daily.
• Dose modification: the recommended maximum dose in geriatric patients and patients with mild hepatic impairment is 2.8 mg  (1 sublingual tablet) once daily at bedtime.
• Tonmya is not recommended in patients with moderate or severe hepatic impairment.

Tonmya sublingual tablets: 2.8 mg of cyclobenzaprine hydrochloride

What happens if I miss a dose?

If you miss a dose, take the next dose at the regularly scheduled time the following evening. Patients should not take two doses to make up for a missed dose.

What other drugs will affect this medicine?

Other drugs may interact with Tonmya, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines, especially if you take

• MAO Inhibitors: Life-threatening interactions may occur 
• Other serotonergic Drugs such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors as serotonin syndrome has been reported with these medicines. Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). 
• CNS Depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced 
• Tramadol: Seizure risk may be enhanced
• Guanethidine: Antihypertensive effect may be blocked.

Not all possible interactions are listed in this medication guide.

Storage

• Store at room temperature (20°C to 25°C [68°F to 77°F]). 
• Store and dispense in original container and protect from moisture. 
• Remove the polyester coil on first use and discard. 
• Keep the desiccant canister in the bottle for the entire period of use. 

Ingredients

Active ingredient: cyclobenzaprine hydrochloride

Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone (Type A), D&C Yellow No.10, dibasic potassium phosphate, mannitol, and sodium stearyl fumarate. 

Company

Tonyma Tonix Medicines, Inc. 26 Main Street – Suite 101, Chatham, NJ 07928 

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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