Tonmya

Tonmya is a new non-opioid prescription treatment for fibromyalgia used to help reduce pain, improve sleep quality, and relieve fatigue in adults.

Tonmya is taken once daily at bedtime, as a small tablet that dissolves under the tongue.

Tonmya has been shown to improve fibromyalgia pain as early as the first week of treatment, with continued improvement of pain relief, better sleep, and less fatigue, over time.

Tonmya is the only brand of cyclobenzaprine HCl FDA-approved for fibromyalgia. Other cyclobenzaprine products (like Flexeril or Amrix and their generics) are not FDA-approved for fibromyalgia; they are only approved for short-term treatment of acute muscle spasm.

Tonmya is FDA-approved for the treatment of fibromyalgia in adults. It was granted on August 15, 2025, after positive results from clinical trials RELIEF (NCT04172831), RESILIENT (NCT05273749).

Tonmya’s clinical trials 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 acting on several receptors in the brain and nervous system that help regulate pain, sleep, and mood (including serotonin, adrenergic, histamine, and muscarinic receptors).

Because Tonmya is absorbed under the tongue, it bypasses much of the usual processing in the liver that happens with standard swallowed tablets. This reduces the formation of a long-lasting active breakdown product called norcyclobenzaprine, which may help improve tolerability.

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 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.

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

Tell your health care provider if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. You should not take this medicine if you are planning to become pregnant or during the first trimester (first 12 weeks) of pregnancy.Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Tonmya.
• Use effective birth control (contraception) during treatment with this medicine and for 2 weeks after the final dose.
• Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you are pregnant during treatment with Tonmya.
• If you are exposed to this medicine during pregnancy, contact Tonix Medicine, Inc., at 1-888-869-7633 (1-888-TNXPMED).

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed while using Tonmya. This medicine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

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.

Tonmya may harm an unborn baby: 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 who are able to become pregnant should be made aware of the potential risk 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 side effects: Tricyclic Antidepressants (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 side effects: 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.

Sleepiness, slowed thinking, and physical response times. Do not drive, operate machinery, or do other dangerous activities until you know how this medicine affects you.

Oral side effects: 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.

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

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.

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.

HCPs and patients often use the Tonmya Prescribing Information for more detailed information about this medicine. The Prescribing Information contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information is sometimes called the Tonmya Package Insert or the FDA label.

• 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.

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.

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