Is Baclofen a Controlled Substance? Legal Status Explained

What you will learn

• Baclofen is not classified as a controlled substance under the U.S. Controlled Substances Act, but it does require a prescription.
• This muscle relaxer cannot be purchased over the counter and must be obtained through a healthcare provider.
• Baclofen is FDA-approved for treating muscle spasticity related to conditions like multiple sclerosis and spinal cord injuries.
• While baclofen has low abuse potential, it can cause physical dependence and dangerous withdrawal symptoms if stopped abruptly.

Introduction: Quick Answer and Why It Matters

The United States does not classify baclofen as a controlled substance. However, it is a prescription-only medication [1], which means you cannot purchase it over the counter.

Baclofen is a muscle relaxant primarily used to treat muscle spasticity caused by conditions like multiple sclerosis, cerebral palsy, and spinal cord injuries. Understanding its legal status matters if you’re considering this medication, worried about abuse potential, or wondering whether you can buy it without a prescription.

What Is Baclofen?

Baclofen is a prescription muscle relaxant [2] originally developed for epilepsy but later found more effective for managing muscle spasticity [3]. It works as a GABA-B receptor agonist, mimicking a naturally occurring brain chemical that helps calm nerve activity. By activating GABA-B receptors in the spinal cord, baclofen reduces nerve signals that cause muscles to tighten and spasm.

The medication comes in oral tablets (10 mg and 20 mg), oral solution, and for severe cases, an intrathecal pump that delivers medication directly into spinal fluid. Typical dosing starts with 5 mg three times daily, with gradual increases up to a maximum of 80 mg per day.

Baclofen’s Legal and Regulatory Status

A controlled substance is a drug regulated under the U.S. Controlled Substances Act because it has significant potential for abuse or dependence. These drugs are placed into schedules (I through V) based on their medical usefulness and risk level.

Baclofen is not scheduled under the Controlled Substances Act. The DEA and FDA have determined that baclofen has low abuse potential and doesn’t warrant the strict controls applied to scheduled drugs. However, the FDA regulates baclofen as prescription-only due to potential side effects and the need for medical monitoring. Healthcare providers must evaluate each patient’s condition, determine appropriate dosing, and monitor for adverse reactions.

Can You Buy Baclofen Over the Counter?

No, you cannot purchase baclofen over the counter despite not being a controlled substance. It requires a valid prescription from a licensed healthcare provider because it can cause significant side effects including drowsiness, dizziness, confusion, and nausea [3]. More seriously, stopping baclofen abruptly can trigger severe withdrawal symptoms [1], including fever, muscle rigidity, hallucinations, and seizures.

No true muscle relaxants are available over the counter [2]. While you can buy pain relievers like ibuprofen or acetaminophen for muscle pain, these work differently than medications like baclofen that specifically target muscle spasticity. If you’re experiencing muscle spasms, consult a healthcare provider for proper evaluation.

FDA-Approved Uses

The FDA has approved baclofen specifically for treating reversible spasticity [3]. Multiple sclerosis commonly causes muscle spasticity, and baclofen helps reduce painful muscle contractions. Spinal cord injuries often result in spasticity below the injury level, and baclofen can significantly improve quality of life by reducing flexor spasms and associated pain.

Other conditions that may benefit include cerebral palsy, stroke, traumatic brain injury, and certain neurological disorders that cause increased muscle tone. For severe spasticity unresponsive to oral baclofen, doctors may recommend an intrathecal baclofen pump for targeted delivery.

Off-Label Uses and Emerging Research

While FDA-approved only for spasticity, doctors sometimes prescribe baclofen off-label (non-FDA-approved uses) for other conditions. Alcohol use disorder has emerged as a promising research area, with some studies suggesting baclofen may reduce alcohol cravings and anxiety [4]. However, it’s not FDA-approved for this indication.

Other off-label uses include trigeminal neuralgia, gastroesophageal reflux disease, intractable hiccups, and certain pediatric spasticity cases. Off-label use requires careful medical supervision, with healthcare providers weighing potential benefits against risks.

Side Effects and Risks

Common side effects [3] include drowsiness, dizziness, weakness, fatigue, nausea, and headache. These are usually most pronounced when starting medication or increasing doses.

Serious reactions require immediate medical attention: severe drowsiness, hallucinations, mood changes, and seizures (particularly during withdrawal). Even though baclofen isn’t a controlled substance, your body can become physically dependent after regular use. Stopping abruptly can trigger dangerous withdrawal symptoms [1], including high fever, altered mental status, muscle rigidity, and seizures that can be life-threatening.

Combining baclofen with alcohol, benzodiazepines, opioids, or other central nervous system depressants [5] dramatically increases sedation and respiratory depression (inadequate breathing) risks.

Baclofen vs. Other Muscle Relaxants

Baclofen specifically treats spasticity caused by neurological conditions. Tizanidine is another spasticity medication that’s prescription-only but not controlled. Cyclobenzaprine treats acute musculoskeletal pain, also prescription-only and not controlled.

Carisoprodol (Soma) is a Schedule IV controlled substance due to abuse potential. Methocarbamol and metaxalone are prescription muscle relaxants that are not controlled.

Baclofen stands out for its specific effectiveness in neurological spasticity, relatively low abuse potential, and availability in intrathecal form. These characteristics explain why it’s not classified as a controlled substance despite requiring a prescription.

Safe Use and Tapering Guidelines

Using baclofen safely requires following your healthcare provider’s instructions. Dosing typically starts low and increases gradually [3] to minimize side effects. Your doctor will monitor your response and adjust to find the lowest effective dose.

Tapering is essential when discontinuing baclofen, especially after long-term use. Your provider will create a gradual dose reduction schedule over weeks or months to prevent dangerous withdrawal. Never stop abruptly [1] without medical guidance.

Physical therapy, stretching, and heat or cold therapy can enhance baclofen’s effectiveness. At Ascendant, we integrate trauma-informed care with experiential therapies like psychodrama and evidence-based treatments including Eye Movement Desensitization and Reprocessing (EMDR), a type of therapy that helps people heal from trauma; parts work, which views the self as a composite of various “parts” rather than a single whole, and Acceptance and Commitment Therapy to address chronic pain and spasticity comprehensively.

Conclusion and Next Steps

Baclofen is a prescription muscle relaxer that’s not classified as a controlled substance, reflecting its proven effectiveness for treating muscle spasticity with relatively low abuse potential. However, the prescription-only requirement acknowledges important safety considerations including side effects, drug interactions, and withdrawal risks [2].

Key takeaways: baclofen cannot be purchased over the counter, requires medical supervision throughout treatment, and should never be stopped abruptly after regular use. While not scheduled like some medications, baclofen demands respect and careful management.

You need to visit a healthcare provider for personal evaluation when you experience muscle spasticity or when you want to determine if baclofen will work for you. At Ascendant, we recognize that managing chronic conditions involves addressing interconnected physical, emotional, and psychological needs. Our treatment program uses trauma-sensitive methods together with hands-on therapy approaches and research-backed interventions. Our team provides support to help you achieve wellness through our services for medication management and substance misuse treatment.

Amanda is a prolific medical content writer specializing in eating disorders and addiction treatment. She graduated Magna Cum Laude from Purdue University with a B.S. in Social Work. Read more