Is baclofen a controlled substance?

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Last updated: May 12, 2025View editorial policy

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From the Guidelines

Baclofen is not classified as a controlled substance in the United States under the Controlled Substances Act. It is a prescription medication that functions as a muscle relaxant and antispastic agent, primarily used to treat muscle spasticity associated with conditions like multiple sclerosis and spinal cord injuries. While baclofen requires a prescription from a healthcare provider, it does not carry the same regulatory restrictions as controlled substances such as opioids or benzodiazepines. This classification reflects its relatively lower potential for abuse and dependence compared to controlled medications, as noted in studies such as 1. However, patients should still use baclofen only as prescribed, as it can cause side effects including drowsiness, dizziness, and weakness. Abrupt discontinuation of baclofen can lead to withdrawal symptoms, so any dosage changes should be done gradually under medical supervision. Despite not being controlled, healthcare providers still monitor its use carefully due to potential for misuse in some cases.

Some key points to consider when prescribing baclofen include:

  • It is used to treat muscle spasticity resulting in pain, poor skin hygiene, or decreased function, as recommended in guidelines such as 1.
  • The French ANSM has issued a temporary recommendation for the use of baclofen for the treatment of alcohol use disorder, with a maximum dose of 80 mg/day, as mentioned in 1.
  • Baclofen has a different pharmacological profile compared to other muscle relaxants like carisoprodol, which is classified as a controlled substance due to its abuse and addiction potential, as discussed in 1.

Overall, the use of baclofen should be carefully monitored and managed by healthcare providers to minimize potential risks and maximize benefits, particularly in patients with a history of substance abuse or dependence.

From the Research

Baclofen Classification

  • Baclofen is not explicitly classified as a controlled substance in the provided studies 2, 3, 4, 5, 6.
  • However, its potential for abuse and dependence is noted in several studies, particularly in the context of substance use disorders 3, 4.

Abuse Potential

  • A study published in 2023 found that baclofen has intrinsic abuse potential, with cases of non-medical use and misuse reported 3.
  • The most common reason for misuse was euphoria search, and routes of administration included oral, snorting, and sublingual use 3.
  • Another study published in 2020 noted that off-label prescription of baclofen remains unsafe due to the risk of self-poisoning and potential co-ingestants, especially CNS depressants 2.

Regulatory Status

  • There is no explicit mention of baclofen being a controlled substance in the provided studies 2, 3, 4, 5, 6.
  • However, the studies suggest that baclofen should be prescribed with caution and under strict medical supervision due to its potential for abuse and dependence 3, 4.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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