| FIELD OF APPLICATION | DETAILS |
|---|---|
| Generic Name | Metaxalone |
| Active Ingredient | Metaxalone |
| US Brand Names | Skelaxin, Generic formulations |
| Drug Category | Muscle Relaxants |
| Drug Class | Skeletal Muscle Relaxant (Central Nervous System Depressant) |
| Route of Administration | Oral (Tablets) |
| FDA Approval Status | FDA approved in August 1962 Approved |
Metaxalone Overview
Metaxalone is a prescription muscle relaxant used to treat discomfort from sudden, painful muscle conditions like strains, sprains, and severe spasms. Doctors prescribe this oral tablet along with rest and physical therapy to help relax tight muscles and relieve pain.
Key Facts Summary:
What Is Metaxalone and How Does It Work?
Metaxalone is a single active ingredient medicine that helps calm painful muscle spasms.
Mechanism of Action
Interestingly, Metaxalone does not work directly on the muscle fibers themselves. Instead, it works inside the central nervous system (the brain and spinal cord).
When you injure a muscle, your nerves send rapid pain signals to your brain, causing the muscle to tighten up or spasm as a protective reflex. Metaxalone depresses the central nervous system, which means it slows down these rapid signals. This creates an overall calming and sedative effect on the body, which helps the tense muscles relax and decreases your pain.
Is Metaxalone FDA Approved?
Yes, Metaxalone is officially approved by the United States Food and Drug Administration. It is prescribed for short-term use to help manage acute muscle injuries.
What Is Metaxalone Used For?
- Relief of discomfort associated with acute, painful musculoskeletal conditions (such as severe muscle spasms, sprains, or back pain).
- Limitations of Use: It is meant to be used as an add-on therapy alongside rest, physical therapy, and other supportive measures. It is not intended for long-term chronic pain management.
Before Taking Metaxalone: Contraindications and Precautions
Your doctor will review your liver health, kidney function, and blood tests before prescribing this medicine. Certain people with a history of blood disorders should not take this drug.
Who Should Not Take Metaxalone?
- Anyone with a known severe hypersensitivity or allergic reaction to Metaxalone or any of its inactive ingredients.
- Anyone with a known tendency toward drug-induced blood disorders, such as hemolytic anemia.
- Patients with significantly impaired kidney or liver function.
Metaxalone, Pregnancy and Fertility
Discuss pregnancy plans with your doctor. It is not fully known if Metaxalone can harm an unborn baby. It is unknown if Metaxalone passes into human breast milk. Discuss the risks of breastfeeding with your doctor.
Tell Your Doctor Before Taking Metaxalone
- Disclose any history of liver disease or kidney disease.
- Inform your provider if you have a history of anemia or other red blood cell disorders.
- Share if you are taking any other medicines that make you sleepy, including anxiety medications, sleep aids, or strong pain relievers.
- Provide a complete list of all prescription drugs, over-the-counter medicines, and daily supplements you take.
Metaxalone Dosage and Administration
Metaxalone is supplied as an 800 mg oral tablet. It is usually taken several times throughout the day to keep muscles relaxed.
Standard Metaxalone Dosing
- Recommended Dose for Adults and Children over 12: One 800 mg tablet taken by mouth three to four times a day.
- Total Daily Dose: Do not exceed 3200 mg (four tablets) in a 24-hour period.
How Metaxalone Is Administered
- Swallow the tablet whole with a glass of water.
- Food Warning: Taking Metaxalone with a high-fat meal significantly increases how much of the drug your body absorbs. This can make side effects like dizziness and extreme sleepiness much worse. It is best to be consistent with how you take it, and ask your doctor if you should take it on an empty stomach.
Metaxalone Clinical Efficacy and Research
Metaxalone has been shown to effectively reduce muscle spasms and pain in patients recovering from acute musculoskeletal injuries. Because it acts on the central nervous system, much of its benefit comes from its mild sedative properties, which help patients rest and allow the injured muscle to heal. It is most effective when combined with physical therapy and proper rest.
Metaxalone Side Effects and Safety Profile
This medication does not currently carry a Black Box Warning from the FDA. However, as with all potent prescription medications, it is essential to remain aware of the severe warnings and potential risks associated with its use. Strict adherence to prescribing guidelines and routine medical monitoring is still highly recommended.
While Metaxalone helps relax tight muscles, its action on the brain can cause significant drowsiness and rare but serious liver or blood issues.
Common Metaxalone Side Effects
- Drowsiness and sleepiness.
- Dizziness or a feeling of lightheadedness.
- Headache.
- Nausea, vomiting, or an upset stomach.
- Nervousness or irritability.
Serious Metaxalone Adverse Events
- Central Nervous System Depression: Severe drowsiness, dizziness, loss of coordination, and impaired mental alertness.
- Liver Toxicity and Anemia: Drug-induced liver damage, jaundice (yellowing of the skin or eyes), or a dangerous drop in red blood cells (hemolytic anemia).
- Serotonin Syndrome: A rare, life-threatening chemical imbalance in the brain causing confusion, fast heart rate, hyperreflexia, and stiff muscles, especially when combined with certain antidepressants.
- Severe allergic reactions (hives, difficulty breathing, swelling of the face).
Managing Metaxalone Side Effects
If you feel dizzy or sleepy after taking the pill, do not drive, operate heavy machinery, or make important decisions. Taking the medicine at the same time each day can help your body adjust. If you notice yellowing of your eyes, extreme fatigue, or a sudden skin rash, stop taking the medication and contact your doctor immediately.
Metaxalone Drug Interactions and What to Avoid
Because Metaxalone slows down your central nervous system, mixing it with other drugs that do the same thing can be very dangerous.
Metaxalone Drug-Drug Interactions
- Central Nervous System Depressants: Combining this medicine with opioids, benzodiazepines (like Valium or Xanax), or sleep aids significantly increases the risk of severe drowsiness and slowed breathing.
- Antidepressants (SSRIs, SNRIs, MAOIs): Taking Metaxalone with these medicines can increase your risk of developing serotonin syndrome.
Metaxalone, Food and Alcohol
- High-Fat Foods: Taking the tablet with a heavy or high-fat meal can cause your body to absorb too much of the drug at once, leading to severe drowsiness.
- Avoid alcohol completely. Alcohol drastically increases the sedative effects of this medicine, raising your risk for falls, severe dizziness, and dangerous breathing problems.
Metaxalone Missed Dose, Overdose and Storage
Taking the medication exactly as prescribed ensures your muscles stay relaxed without causing extreme sedation.
Missed Dose of Metaxalone
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two tablets at the same time to make up for a missed pill.
Metaxalone Overdose and Emergency
An overdose of Metaxalone can cause severe extreme drowsiness, dangerous breathing problems, and loss of consciousness. If you suspect an overdose, contact a poison control center or seek emergency medical care immediately.
How to Store Metaxalone
- Store the tablets at room temperature between 59°F and 86°F (15°C and 30°C).
- Keep the medicine in its original container, tightly closed, to protect it from moisture.
- Keep safely out of reach of children and pets.
Metaxalone Patient Management and Monitoring
Your doctor will monitor your pain levels and side effects to determine how long you need to stay on the medication.
Tests Before Starting Metaxalone
- Baseline liver function tests, especially for patients with a history of liver issues.
- A review of your medical history to ensure you do not have anemia.
Monitoring During Metaxalone Treatment
- Periodic liver function blood tests if you are taking the medicine for a longer period.
- Complete blood count (CBC) tests to ensure your red blood cell levels remain healthy.
- Monitoring for signs of extreme sleepiness or confusion.
Metaxalone Do’s and Don’ts
- DO rest the injured muscle and follow your physical therapy instructions.
- DO talk to your doctor about how food affects your dose if you experience strong side effects after eating.
- DON’T drive or do anything that requires full attention until you know how the medicine affects you.
- DON’T mix this medicine with alcohol or other sedating drugs.
Frequently Asked Questions
What is this medicine used for?
It is a prescription muscle relaxant used to treat sudden, painful muscle conditions like severe back spasms, sprains, and strains.
How does Metaxalone work?
It works by slowing down the signals in your brain and spinal cord. This produces a calming effect that helps your tense muscles relax.
Does this medicine make you sleepy?
Yes, drowsiness and dizziness are the most common side effects. You should not drive or operate machinery until you know how the drug affects you.
Why does my doctor care about what I eat with this medicine?
Taking Metaxalone with a very heavy or high-fat meal can cause your body to absorb too much of the drug at once. This can make the side effects, like sleepiness and dizziness, much worse.
Can I drink alcohol while taking Metaxalone?
No. You must avoid alcohol. Mixing alcohol with this medication can cause dangerous side effects, including severe drowsiness and trouble breathing.
Is this medicine a painkiller?
It is not a traditional painkiller (like ibuprofen or opioids). However, by relaxing the severe muscle spasms, it greatly reduces the pain associated with the injury.
References
- U.S. FDA prescribing information for Metaxalone tablets
- U.S. FDA Drugs@FDA drug approval overview (Application No. 022503)
- American College of Physicians Guidelines on Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain
Legal Disclaimer
The information provided is for educational and informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider at any hospital or any local clinic before starting or stopping any medication.

























