Tonmya (cyclobenzaprine) is a medicine for fibromyalgia in adults that works differently from other options. It was approved by the FDA in 2025 and comes as a tablet that you put under the tongue once daily at bedtime. Cyclobenzaprine was originally approved in the USA in 1977 for muscle spasms and related pain.
How Does Tonmya Work in Fibromyalgia?
Fibromyalgia is a long-term (chronic) condition that causes pain. People may feel aches and tenderness throughout their body. Fibromyalgia can also cause symptoms like tiredness and sleep problems.
Tonmya may help people with pain and sleep problems due to fibromyalgia by affecting neurotransmitters.
Is Tonmya Right for Me?
Tonmya may be the right choice for you if you are an adult with fibromyalgia and you want to try something that you just use once a day at bedtime. This medicine may not be a good choice if you need to drive, operate machines, or do other activities that require alertness in the middle of the night.
Your health care provider will examine you, review your medical history, and possibly order blood or imaging tests to make sure Tonmya is right for you.
How Was Tonmya Studied for Fibromyalgia?
Three studies were done to look at the benefits and risks of Tonmya in adults with fibromyalgia. People had to have overall body pain in at least four out of five body areas with symptoms that stayed about the same for at least three months.9
People in all three studies were randomly selected to take either Tonmya (735 people) or a placebo (739 people). The placebo looked like Tonmya but didn’t contain any medicine. Neither the people in the studies nor the doctors knew who took Tonmya or the placebo until the study was over.
The main question these studies wanted to answer was how well Tonmya could reduce fibromyalgia pain. To find out, researchers measured the changes in patients’ pain using an 11-point numeric rating scale (NRS). Each day, patients recorded their pain over the past 24 hours in a diary, rating it from 0 (no pain) to 10 (worst possible pain). The researchers then calculated a weekly average of these daily scores and tracked how the average changed over 14 weeks from the start of the study. To be in the studies, people had to have an average daily pain score of at least 4 on the NRS.
Who was excluded from the studies?
Certain people were not allowed to take part in the studies, including the following:
- People with certain medical problems or mental health conditions that could affect their safety or ability to take part, such as infections, autoimmune conditions, and other pain conditions
- People who were pregnant or nursing
- People who could not stop taking certain medicines, including other forms of cyclobenzaprine
What were the study populations?
- Their ages ranged from 18 to 65, with an average of 49
- About 95% were female and 5% male
- About 86% were White, 9% Black, and 1% Asian
- About 83% were not Hispanic or Latino
How long were the studies?
Patients took Tonmya or the placebo in the form of a tablet placed under the tongue every night at bedtime once daily for about 3.5 months (14 weeks). Patients took one tablet for the first two weeks and then took two tablets thereafter.
What Were the Main Benefits of Tonmya Seen in the Studies?
In two of the three studies, patients using Tonmya rated their pain lower. At the start of the study, average pain scores on the 11-point NRS were about the same in the Tonmya and placebo groups, around 6. Over 14 weeks, most people using Tonmya saw their pain drop by 1.6 to 2.1 points. Most patients using the placebo had smaller drops: 0.9 to 1.7 points.
What Are the Side Effects of Tonmya, and How Can I Prevent or Manage Them?
- Numbness, tingling, unusual taste, discomfort, or pain in the mouth. Take a sip of water to wet your mouth before using Tonmya to lower the risk of these symptoms. Mouth symptoms started a few minutes after using Tonmya, and most went away within an hour. A few patients had more serious mouth symptoms, but most of them went away a few days after stopping Tonmya. Stay away from hot, cold, or acidic drinks until morning because these can irritate your mouth. If your mouth is numb, you may hurt yourself because you will not feel the pain or irritation.
- Feeling tired or sleepy. You will use Tonmya at bedtime, but you may still feel sleepy during the day. Do not drink alcohol or take other medicines that cause sleepiness. Be careful when driving or operating machines that require alertness or concentration until you know how Tonmya affects you. If you need to get out of bed in the middle of the night, do so slowly.
- Dry mouth. Drink plenty of water and avoid drinks with caffeine. You can also try chewing sugar-free gum. Your pharmacist may recommend gels, sprays, or lozenges to help keep your mouth moist.
- Canker sores. Stay away from spicy, acidic, or very hot foods. Your pharmacist may suggest medicines you can put on the sores to help them heal faster and ease the pain.
Contact your health care provider if any of these side effects get worse or do not go away.
These are not all the possible side effects of Tonmya. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can report side effects to the FDA at 800-FDA-1088 or www.fda.gov/medwatch. You can also report side effects to the manufacturer, Tonix Medicines Inc., at 888-869-7633 (888-TNXPMED).
How Do I Know if Tonmya Is Working?
You’ll know Tonmya is working if your pain gradually feels less intense. It can take a few weeks to notice the difference. Your health care provider will keep track of how Tonmya is helping with your pain.
Do not stop using Tonmya or change your dose unless your health care provider tells you to do so.
How Do Other Medicines Interact With Tonmya?
Tell your health care providers and pharmacist about all the other prescription and nonprescription medicines, vitamins, supplements, and herbal products you take before starting Tonmya.
Tonmya works in a way similar to certain antidepressants called tricyclic antidepressants (TCAs), increasing the effect of some brain chemicals like serotonin and norepinephrine and blocking others, such as acetylcholine (anticholinergic effects). Using Tonmya with other medicines that also affect these chemicals can cause serious side effects, including serotonin syndrome.
Serotonin syndrome can be life-threatening. For this reason, Tonmya cannot be used with a group of medicines known as monoamine oxidase inhibitors (MAOI). Examples are phenelzine and selegiline. Do not use Tonmya and tell your health care provider if you take an MAOI or have taken one in the past two weeks.
Certain other medicines, including some for depression and pain, may be used with Tonmya under your health care provider’s supervision. Contact your health care provider right away if you notice any symptoms of serotonin syndrome. Symptoms may include confusion, agitation, unusual thoughts, fast heartbeat, high blood pressure, sweating, fever, stiff muscles, shaking, trouble walking, nausea, vomiting, or diarrhea.
Using Tonmya with certain medicines, including some cold, allergy, or motion sickness medicines, can make side effects like dry mouth worse. The combination of these medicines with Tonmya can also increase the risk of serious problems, especially if you have glaucoma or trouble peeing, such as from benign prostatic hypertrophy. Always tell your pharmacist that you are using Tonmya before using any over-the-counter (OTC) medicines.
Tonmya can make you extra sleepy or dizzy if you also drink alcohol or take certain pain, sleep, or seizure medicines. Stay away from alcohol and let your health care provider know if you feel too sleepy when using Tonmya.
Talk to your health care provider before starting any other prescription and nonprescription medicines, vitamins, supplements, and herbal products while you are on Tonmya. They will decide if you need to stop taking a medicine while you are using Tonmya or if you need to adjust the dose of these medicines. Your pharmacist can tell you which prescription and nonprescription medicines interact with Tonmya.
How Can I Get Tonmya?
You will need a prescription from a health care provider. For any questions about Tonmya, contact your health care provider. You can also contact the manufacturer, Tonix Medicines, at 888- 869-7633 (888-TNXPMED).
