About Tonmya™
For fibromyalgia tomorrow,
TONMYA tonight
What is TONMYA?
TONMYA is the first and only sublingual (under‑the‑tongue) medication for the treatment of fibromyalgia in adults. It's designed specifically to help the core symptoms of fibromyalgia: widespread pain, disturbed sleep, and fatigue.
TONMYA is not approved as a treatment for sleep disorders or fatigue.
Unique formulation
TONMYA dissolves under the tongue and is designed to release a low dose of cyclobenzaprine, which gets absorbed directly into the bloodstream.
Fits into your routine
TONMYA is taken once nightly before bed, so it fits into your bedtime routine.
Symptom improvement that lasts
TONMYA continued to work over the course of a 14‑week study.
Results with TONMYA
TONMYA improved the core symptoms of fibromyalgia
In two 14‑week clinical trials, people taking TONMYA experienced:
Significant improvements
in widespread pain
These results were used for the
FDA approval of TONMYA
In one clinical trial, people taking TONMYA experienced:
Improved sleep quality
Less fatigue
However, a second trial did not show these results.
In a 14-week clinical trial, people taking TONMYA responded to a questionnaire and reported less difficulty in certain activities, including:
Walking continuously
for 20 minutes
Lifting and carrying a
bag of groceries
Preparing a homemade
dinner
A second trial did not show these results.
No conclusions can be drawn related to improvements in quality of life.
How to Take TONMYA
The next step in your bedtime routine
TONMYA should be taken once daily at bedtime, around the same time each evening.
Before taking TONMYA:
Complete your oral care
Finish brushing and flossing your teeth, and using mouthwash.
Drink some water
Take a few sips of water to make sure your mouth and the area under your tongue are moistened.
How to take TONMYA:
Place one or two* TONMYA tablets under your tongue. Avoid talking for at least five minutes, until the tablets are fully dissolved.
Avoid eating or drinking for at least 15 minutes until the tablet has completely dissolved. Don't drink any hot, cold, or acidic beverages until you wake up the next morning.
Get into bed and prepare for sleep.
*Most patients will take one tablet for the first 14 days and then increase to two tablets. Dosage varies per person based on age or pre-existing liver conditions. Your healthcare provider will tell you how many tablets to take and may change your dose if needed.
What if I miss a dose?
If you missed a TONMYA bedtime dose, take TONMYA the next evening. Do not take a missed dose during the day. Do not take two doses to make up for a missed dose.
If you are able to get pregnant, your healthcare provider should do a pregnancy test before you start treatment with TONMYA. You should not take TONMYA if you are planning to become pregnant or during the first trimester (first 12 weeks) of pregnancy. Use effective birth control (contraception) during treatment with TONMYA and for two weeks after the final dose.
You should not drink alcohol until you know how TONMYA affects you. Taking TONMYA with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times, and cause symptoms such as sleepiness. Do not drive, operate machinery, or do other dangerous activities until you know how TONMYA affects you.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Not just another cyclobenzaprine
TONMYA has a unique formulation that dissolves under the tongue. TONMYA is designed to get absorbed through your mouth instead of your stomach, so it gets into your system faster than a standard, swallowed pill.
How TONMYA works
Because TONMYA is designed to dissolve under your tongue, it gets absorbed quickly into your bloodstream and doesn't get broken down in your liver.
Side effects of tonmya
Side effects of TONMYA were
generally manageable
The most common side effects reported with TONMYA in clinical trials were mouth numbness, mouth discomfort, abnormal taste, feeling sleepy, tingling in the mouth, mouth pain, fatigue, dry mouth, and canker sores.
Changes in blood pressure and weight were similar to those in people not taking TONMYA, and there were no reports of any sexual health issues or trouble thinking clearly.
Mouth-related side effects were usually mild or moderate and went away within about an hour. One-third of these mouth-related side effects lasted longer than an hour, some of which were present the next morning.
Start TONMYA with
the right support
WHAT IS TONMYA?
TONMYA is a prescription medicine used in adults for the treatment of fibromyalgia. It is not known if TONMYA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHO SHOULD NOT TAKE TONMYA?
Do not take TONMYA if you:
- are allergic to cyclobenzaprine or any of the ingredients in TONMYA. Get medical help right away if you have symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of your face or tongue, or itching
- are taking an antidepressant medicine called a monoamine oxidase (MAO) inhibitor or if it has been 14 days or less since you stopped taking an MAO inhibitor
- have had a recent heart attack, heart rhythm problems (arrhythmias), or heart failure
- have an overactive thyroid (hyperthyroidism)
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE USING TONMYA?
Tell your healthcare provider if you:
- have a history of seizures
- have trouble emptying your bladder (urinary retention)
- have a history of eye problems, including glaucoma
- have liver problems
- are pregnant or plan to become pregnant. TONMYA may harm your unborn baby. You should not take TONMYA if you are planning to become pregnant or during the first trimester (first 12 weeks) of pregnancy
- 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 TONMYA 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 TONMYA during pregnancy, contact Tonix Medicine, Inc., at 1‑888‑869‑7633 (1‑888‑TNXPMED)
- are breastfeeding or plan to breastfeed. TONMYA may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TONMYA
Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:
- a medicine to treat depression, mood, anxiety, psychotic, or thought disorders
- a pain medicine called tramadol or meperidine
- bupropion
- verapamil
- anticholinergic medicines
- barbiturates or other medicines that depress your central nervous system (CNS depressants)
- a blood pressure medicine called guanethidine
HOW SHOULD I TAKE TONMYA?
- Take TONMYA exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much TONMYA to take.
- Your healthcare provider may change your TONMYA dose if needed.
- Take TONMYA 1 time a day at bedtime, around the same time each evening.
- Take TONMYA after brushing your teeth and other oral care is completed.
- Your mouth and the area under your tongue (sublingual) should be moist when you take TONMYA. Drink a few sips of water before you take TONMYA.
- Place the prescribed number of TONMYA sublingual tablet(s) under your tongue until dissolved.
- Do not swallow whole, cut, crush, or chew TONMYA sublingual tablets.
- Avoid eating or drinking for at least 15 minutes after the TONMYA sublingual tablet is completely dissolved. Avoid any hot, cold, or acidic beverages until the morning.
- Avoid talking for at least 5 minutes after taking TONMYA.
- If you miss a dose of TONMYA, take your next dose the following evening. Do not take a missed dose during the day. Do not take 2 doses to make up for a missed dose.
- If you take too much TONMYA, call your healthcare provider or the Poison Help line at 1‑800‑222‑1222 or go to the nearest hospital emergency room right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF TONMYA?
Serious side effects may include:
- Serotonin syndrome is a serious medical condition that may happen when TONMYA is taken with certain other medicines. Go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of serotonin syndrome:
- confusion, agitation, seeing or hearing things that are not real (hallucinations), coma, or other changes in mental status
- high body temperature (hyperthermia)
- shaking (tremor), coordination problems, or muscle twitching (overactive reflexes)
- fast heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle stiffness or tightness
- TONMYA may cause serious side effects that may lead to heart attack or stroke. Symptoms may include:
- irregular or abnormal heartbeats (arrhythmias)
- fast heartbeat (tachycardia)
- dizziness
- feeling faint or lightheaded
- chest pain or discomfort
- shortness of breath
- TONMYA can cause side effects to the lining inside your mouth, including numbness, tingling, discomfort, pain, irritation, swelling (inflammation), and sores (lesions). These side effects can happen within minutes of taking TONMYA, and most go away within 60 minutes. Drink a few sips of water before taking TONMYA to decrease your chance of getting numbness or reduced feeling in your mouth. Tell your healthcare provider right away if you have:
- trouble eating, drinking, breathing, or swallowing
- side effects that cover a large area in your mouth
- pain in your mouth that makes it difficult to do your normal activities
Call your healthcare provider right away or go to the emergency room if you have any serious side effects.
The most common side effects include: reduced feeling in your mouth, mouth discomfort, abnormal TONMYA taste, feeling sleepy (somnolence), numbness or tingling in your mouth, mouth pain, tiredness, dry mouth, and sores in your mouth (canker sores).
These are not all the possible side effects of TONMYA.
WHAT SHOULD I AVOID WHILE USING TONMYA?
You should not drink alcohol until you know how TONMYA affects you. Taking TONMYA with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times. Do not drive, operate machinery, or do other dangerous activities until you know how TONMYA affects you.
HOW SHOULD I STORE TONMYA?
- Store at room temperature (20°C to 25°C [68°F to 77°F]), but no lower than 15°C (59°F) and no higher than 30°C (86°F).
- Keep the tablets in the original bottle with the desiccant (moisture absorber) canister, and keep the bottle closed to protect from moisture.
- The TONMYA bottle contains a polyester coil to help protect the sublingual tablets during shipping. Remove the polyester coil from the bottle and throw it away after opening the bottle for the first time.
- Keep out of reach of children.
WHAT ARE THE INGREDIENTS IN TONMYA?
Active ingredient: Cyclobenzaprine hydrochloride USP
Inactive ingredients: Colloidal silicon dioxide, corn starch, crospovidone (Type A), D&C Yellow No.10, dibasic potassium phosphate, mannitol, and sodium stearyl fumarate.
Need help or have questions?
If you are exposed to TONMYA during pregnancy, contact Tonix Medicines, Inc. at 1‑888‑869‑7633 (1‑888‑TNXPMED).
Call your healthcare provider for medical advice about side effects. You may report side effects to Tonix Medicines, Inc. at 1‑888‑869‑7633 or to the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch.