Tonmya™ HCP Homepage

ABOUT Tonmya™

Unique sublingual formulation designed for rapid absorption with bedtime dosing1-3

Formulation

A sublingual formulation of low-dose cyclobenzaprine, uniquely designed for rapid absorption1-3

Steady State TONMYA Concentrations After 20 Days of Dosing2*

Graph of cyclobenzaprine and metabolite levels over 24 hoursGraph of cyclobenzaprine and metabolite levels over 24 hours

*Steady‑state pharmacokinetics of a 5.6‑mg dose of TONMYA (2 x 2.8 mg) sublingual tablets were assessed at Day 20 in a single‑center, comparative pharmacokinetic, open‑label, randomized, multiple‑dose, 2‑arm study in 56 healthy adults.2

NET, norepinephrine transporter.

Sublingual delivery avoids first‑pass hepatic metabolism to reduce metabolite (norcyclobenzaprine) accumulation2,3

  • Non‑sublingual cyclobenzaprine undergoes extensive first‑pass hepatic metabolism, converting ~50% to norcyclobenzaprine—a metabolite linked to wake‑promoting activity via NET inhibition2,3
  • In patients with fibromyalgia, disrupted sleep has been shown to predict future pain and fatigue5-8

Cyclobenzaprine levels peak at approximately 5 hours then taper by morning—aligned with the body's natural rhythms2,4

The sublingual route enables fast absorption, detectable in plasma within minutes2

TONMYA has a half‑life of
~36 hours1

Mechanism of Action

TONMYA offers simultaneous modulation of multiple CNS targets in one agent1-3

Diagram of receptor antagonism showing 5-HT₂A, α₁-adrenergic, H₁-histaminergic, and M₁-muscarinic receptorsDiagram of receptor antagonism showing 5-HT₂A, α₁-adrenergic, H₁-histaminergic, and M₁-muscarinic receptors

Cyclobenzaprine: more active at the key receptors involved in sleep quality
Norcyclobenzaprine: more active on the norepinephrine transporter

NET, norepinephrine transporter; SERT, serotonin transporter.

The mechanism of action of cyclobenzaprine for the treatment of fibromyalgia in adults is unknown.

In in vitro pharmacology studies, cyclobenzaprine demonstrated functional antagonism of 5‑HT2A, α1‑adrenergic, H1‑histaminergic, and M1‑muscarinic acetylcholine receptors.

Dosing & Administration

Taken once nightly at bedtime, TONMYA is a treatment designed to fit routinely into daily life, offering a non‑opioid, non‑addictive option1

The recommended dosage of TONMYA is as follows1:

Starting Dose

Administer a 2.8 mg dose (1 tablet) under the tongue once daily at bedtime.

Target Dose

Administer a 5.6 mg dose (2 tablets; the maximum recommended dosage) under the tongue once daily at bedtime.

Tonmya™ (cyclobenzaprine HCI) sublingual tablets 2.8mg bottle

Not actual size.

  • In geriatric patients and patients with mild hepatic impairment, a 2.8 mg dose (1 tablet; the maximum recommended dosage) administered under the tongue once daily at bedtime is recommended. The use of TONMYA is not recommended in patients with moderate or severe hepatic impairment.
  • TONMYA is contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life‑threatening condition. Caution should be used with concomitant use of TONMYA with alcohol, barbiturates, other CNS depressants, anticholinergics, guanethidine or other similar acting drugs.
  • Pregnancy testing is recommended in females of reproductive potential prior to initiating treatment with TONMYA. Females should avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Advise females of reproductive potential to use effective contraception during TONMYA treatment and for two weeks following the final dose.

How to administer TONMYA1

  • TONMYA should be placed under the tongue until dissolved (should not be swallowed whole, cut, crushed, or chewed).

  • TONMYA should be administered after teeth brushing and other oral care has been completed. Ensure a moist mouth/sublingual area by drinking a few sips of water prior to administration.

  • Avoid eating or drinking for at least 15 minutes after the tablet is completely dissolved and preferably avoid any hot, cold, or acidic beverages until morning.

  • Avoid talking for at least 5 minutes after administration.

For fibromyalgia tomorrow, TONMYA tonight

TONMYA was FDA-approved based on two clinical trials that evaluated adults with fibromyalgia over 14 weeks.

INDICATION

TONMYA is indicated for the treatment of fibromyalgia in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TONMYA is contraindicated:

  • In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
  • With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
  • During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
  • In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS

  • Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
  • Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life‑threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
  • Tricyclic antidepressant‑like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
  • Atropine‑like effects: Use with caution in patients with a history of urinary retention, angle‑closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
  • CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
  • Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA‑treated patients compared to placebo‑treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

  • MAO inhibitors: Life‑threatening interactions may occur.
  • Other serotonergic drugs: Serotonin syndrome has been reported.
  • CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
  • Tramadol: Seizure risk may be enhanced.
  • Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA‑associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse‑event reporting line at 1‑888‑869‑7633 (1‑888‑TNXPMED).
  • Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
  • Pediatric use: The safety and effectiveness of TONMYA have not been established.
  • Geriatric patients: Of the total number of TONMYA‑treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
  • Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA‑associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1‑888‑869‑7633, or the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

References: 1. TONMYA™ (cyclobenzaprine HCI) [prescribing information]. Chatham, NJ: Tonix Medicines, Inc.; 2025. 2. Data on File, Tonix Medicines, Inc. 3. Lederman S, Arnold LM, Vaughn B, Engels JM, Kelley M, Sullivan GM. Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. Pain Medicine, 2025: pnaf089, doi:10.1093/pm/pnaf089 4. Markov D. Neurobiologic Mechanisms of Sleep and Wakefulness. FOCUS. 2014;XII(1):9-15. 5. Nicassio PM, Moxham EG, Schuman CE, Gevirtz RN. The contribution of pain, reported sleep quality, and depressive symptoms to fatigue in fibromyalgia. Pain. 2002;100(3):271-279. doi:10.1016/S0304-3959(02)00300-7 6. Ranum RM, Toussaint LL, Whipple MO, Vincent A. Predictive Bidirectional Relations Between Pain, Fatigue, and Dyscognition in Fibromyalgia. Mayo Clin Proc Innov Qual Outcomes. 2022;6(2):143-147. doi:10.1016/j.mayocpiqo.2021.12.007 7. Bigatti SM, Hernandez AM, Cronan TA, Rand KL. Sleep disturbances in fibromyalgia syndrome: Relationship to pain and depression. Arthritis Care Res. 2008;59(7):961-967. doi:10.1002/art.23828 8. Cetingok S, Seker O, Cetingok H. The relationship between fibromyalgia and depression, anxiety, anxiety sensitivity, fear avoidance beliefs, and quality of life in female patients. Medicine (Baltimore). 2022;101(39):e30868. doi:10.1097/MD.0000000000030868