Is Baclofen a Controlled Substance?

Last Medical Review On: June 23, 2025
Updated On: Jun 23, 2025
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Written by:

Amanda Stevens, B.S.

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Medical Review by:

Dr. Po Chang Hsu MD, MS

Is-Baclofen-a-Controlled-Substance
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    What you will learn
    • Baclofen is not classified as a controlled substance by the DEA.
    • However, this prescription-only muscle relaxant can still cause a high or an overdose at large doses, and is regulated at the state level.
    • Knowing how to manage your baclofen use and recognize key warning signs is key to maintaining safety.

    Baclofen is a muscle relaxant medication with a well-established history of use in various cases of muscle spasticity and pain. Though baclofen may treat some of the same issues, it doesn’t necessarily come with the same risks.

    As the conversation around prescription drug misuse grows louder and more urgent, now is as fitting a time to ask as any: Is baclofen a controlled substance?

    No, Baclofen Is Not a Controlled Substance

    The DEA has not classified baclofen as a controlled substance under the Controlled Substances Act (CSA). This category is typically reserved for potentially addictive drugs with high abuse potential. Baclofen has a lower abuse potential compared to substances classified under the Controlled Substances Act, but dependence, misuse, and withdrawal have been documented, particularly at high doses or with abrupt discontinuation.

    Why do some people claim that baclofen is a controlled substance and/or a narcotic? For one, this prescription muscle relaxant can elicit side effects that sometimes resemble those of opioid drugs.

    Drowsiness is a symptom of baclofen (though high doses are typically required).[1] Anyone who has been under the effects of narcotics, especially for recreational use, will identify this as a commonality between the two.

    Baclofen may be confused with controlled substances due to its CNS effects and misuse potential, but it is not typically used to treat the same conditions as opioids or benzodiazepines. Its prescription-only status is also partially responsible for its misunderstood reputation. To make the distinction between baclofen and narcotics even hazier, this medication also carries some abuse potential.

    Understanding Baclofen’s Abuse Potential

    Baclofen abuse is rare, but the substance can still produce a high and lead to physical dependence. Baclofen acts in the same way that GABA (gamma-aminobutyric acid) does in the body, engaging with the same receptors.[2] When baclofen activates certain types of GABA receptors, it exerts a calming effect on the central nervous system.

    A calmed-down central nervous system means less frequent and intense nerve signals. Baclofen releases the tension in spastic muscles by inhibiting the nerve signals that cause them. Even though baclofen isn’t officially classified as a controlled substance, it can still produce euphoria at very large doses. It still interacts with the central nervous system and can alter your psychological state as a result. [3]

    Not Controlled, but Still Regulated

    Baclofen may not be controlled at the federal level, but there are still several regulatory safeguards in place aimed at legitimizing its use as much as possible. These controls include the prescription requirement, state regulations, and legal penalties for the sale or distribution of the product.

    • Must have a prescription: You will be unable to legally acquire baclofen without a prescription from a licensed healthcare provider.
    • State-level legal provisions: Each state varies, but some are more vigilant in tracking and limiting baclofen prescription.
    • Legal penalties for sale or distribution: Distributing baclofen in any way is still a crime.

    What-Does-Baclofen-Treat

    What Does Baclofen Treat?

    Over 60 years ago, baclofen was first proposed as an epilepsy drug. After standard treatment approaches outpaced it, it lost popularity until it re-emerged in the early 70s as a muscle spasticity drug.

    The FDA has approved Baclofen to treat reversible spasticity in patients with multiple sclerosis and spinal cord injuries.[4] Baclofen is FDA-approved for spasticity related to multiple sclerosis and spinal cord lesions; use in traumatic brain injury is considered off-label.

    The following is an overview of both the FDA-approved and off-label uses of baclofen: [5]

    • Multiple sclerosis: An autoimmune condition in which the body attacks the lining around nerve fibers (myelin sheath). This causes a cascade of potential symptoms, including vision issues, muscle weakness, loss of balance and coordination, and more.
    • Spinal cord injury: Caused either by a traumatic injury or a non-traumatic illness (like degenerative disease of the spine), a spinal cord injury severs communication between the brain and a portion of the body. Many issues, including muscle spasticity, can result.
    • Trigeminal neuralgia: When the trigeminal nerve root is compressed or otherwise disturbed, the area that it innervates, which is much of the face, experiences sudden, stabbing pains. Patients describe the sensation as an “electric shock.”
    • Gastroesophageal reflux disease: Also known as GERD, this is when the stomach acid moves up the esophagus, causing a burning sensation, bitter taste, and other symptoms.
    • Cerebral palsy: This term represents a group of disorders affecting muscle tone, movement, and posture due to brain injuries sustained during development.

    Some studies suggest baclofen may reduce alcohol cravings, particularly in individuals with liver disease, but its efficacy remains debated, and it is not FDA-approved for this use. [6]

    Understanding Baclofen Risks and Precautions

    Baclofen is a typically well-tolerated muscle relaxant. That said, all prescription (and many non-prescription) medications come with risks. Understanding not only the risks themselves, but also which factors raise them is vital for minimizing the potential for adverse effects.

    Common Baclofen Side Effects

    When taken in adherence to prescribed dosage levels, baclofen exerts its effects on the nerves of the spinal cord. While not nearly as severe as with an overdose, side effects are still possible when taking baclofen as prescribed.

    These more common and easily managed side effects include:[7]

    • Intermittent sedation
    • Muscle weakness
    • Confusion
    • Nausea
    • Dizziness

    Side Effects of Baclofen Overdose

    In the event of an overdose, baclofen is less discerning between the nerves of the spinal cord and the brain, greatly increasing its interaction with central nervous system receptors.[8]

    In this case, the depressive effect of baclofen on the central nervous system can cause the following symptoms:

    • Respiratory depression (abnormally slow and shallow breaths)
    • Flaccid paralysis
    • Sudden blood pressure decrease
    • Slowed heart rate
    • Seizures

    Common signs of a baclofen overdose include sleepiness, seizures, hypothermia, coma, vomiting, and respiratory depression.[9]

    Risk Factors and Precautions

    As with any medication or treatment, several factors can increase your chances of experiencing adverse effects when taking baclofen. These include health conditions, the use of certain medications, lifestyle factors, and more.

    People with certain neuropsychiatric disorders, including psychosis and schizophrenia, are at risk for worsening their condition when taking baclofen.[10] This effect has been observed in cases of baclofen injections as well as oral baclofen use.

    Patients with kidney impairment are also advised to proceed with caution when taking baclofen, as the kidneys eliminate baclofen.

    Other factors that may increase your risk of complications or other adverse events include taking baclofen with opioid medications, driving or operating machinery after taking baclofen, a history of seizure disorder, and more.

    Not all of the above precautions automatically disqualify a person from being prescribed baclofen. Evaluating your candidacy for baclofen in person with a healthcare provider is the best way to establish your eligibility safely.

    Battling Baclofen Addiction or Withdrawal Symptoms? Help Is Available

    The risk with baclofen is just as much rooted in its perception as its actual abuse potential. Upon learning that this muscle relaxant is not a controlled substance, people tend to be lulled into a false sense of security.

    If you find yourself experiencing severe withdrawal symptoms or dependence, seeking immediate treatment is just as essential as with any other substance.

    Frequently Asked Questions About Baclofen

    Should I taper off of baclofen?
    How long does baclofen stay in your system after your last dose?
    Can baclofen affect mental health or mood?
    Can baclofen be combined with other medications?
    Sources

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