What is baclofen used for?

What is Baclofen Used For?

Baclofen is FDA-approved specifically for alleviating spasticity resulting from multiple sclerosis and spinal cord injuries/diseases—particularly for relief of flexor spasms, pain, clonus, and muscular rigidity—but is NOT indicated for skeletal muscle spasm from rheumatic disorders, stroke, cerebral palsy, or Parkinson's disease. 1

Primary FDA-Approved Indications

Baclofen tablets are indicated for patients with reversible spasticity where treatment will aid in restoring residual function, specifically: 1

• Multiple sclerosis-related spasticity - particularly effective for flexor spasms, concomitant pain, clonus, and muscular rigidity 1
• Spinal cord injuries and other spinal cord diseases - where spasticity interferes with function or causes nursing care difficulties 1

What Baclofen is NOT For

The FDA explicitly states baclofen is not indicated for: 1

• Skeletal muscle spasm from rheumatic disorders 1
• Stroke (efficacy not established) 1
• Cerebral palsy (efficacy not established) 1
• Parkinson's disease (efficacy not established) 1

Mechanism and Routes of Administration

Baclofen is a GABA-B agonist that acts as a centrally-acting muscle relaxant with spinal action, inhibiting spinal synaptic reflexes: 2, 3

• Oral baclofen - typical dosing 30-80 mg/day divided into 3-4 doses, starting at 5-10 mg/day and titrating slowly 2
• Intrathecal baclofen - reserved for severe spasticity unresponsive to maximum oral doses, requiring only 10% of systemic dose for equivalent effect, with >80% of patients showing improvement in muscle tone and >65% improvement in spasms 2, 4, 3

Treatment Algorithm for Spasticity

The American Heart Association recommends a stepwise approach: 2

1. First-line non-pharmacological: Antispastic positioning, range of motion exercises, stretching, splinting, serial casting 2
2. Focal spasticity: Botulinum toxin (preferred over baclofen for focal applications) 2
3. Generalized spasticity: Oral baclofen, tizanidine, or dantrolene 2
4. Severe refractory spasticity: Intrathecal baclofen for patients unresponsive to oral medications 2, 4

Off-Label Uses with Limited Evidence

While baclofen has been studied for other conditions, evidence is sparse or insufficient: 2, 5, 6

• Alcohol use disorder - some effectiveness shown in reducing alcohol craving in patients with liver cirrhosis 5
• Pain management - minimal data supporting use outside spasticity-related conditions, with only 2 trials for low back pain 2
• Cough suppression - may suppress cough through spinal mechanisms but lacks double-blind placebo-controlled studies for pathologic cough 7

Critical Safety Considerations

Abrupt discontinuation is potentially life-threatening, causing withdrawal syndrome with seizures, hallucinations, delirium, fever, tachycardia, and possible death—baclofen must be tapered slowly over weeks if discontinuation is necessary. 2, 8

High-Risk Populations Requiring Caution:

• Elderly patients - more susceptible to adverse effects (sedation, dizziness, confusion), requiring lower starting doses 2
• Renal impairment - mandatory dose reduction starting at 5 mg/day due to renal clearance and potential 2-3 fold increase in half-life 2
• Dementia patients - should avoid baclofen due to significant cognitive and safety concerns; alternative treatments strongly preferred 8
• Respiratory compromise - can cause respiratory depression as CNS toxicity manifestation 2
• Hepatic dysfunction - may be contraindicated due to increased CNS effects 2

Common Adverse Effects:

Sedation, somnolence, excessive weakness, vertigo, psychological disturbances, dizziness, and gastrointestinal symptoms occur in 10-75% of patients, though most are dose-related and reversible. 2, 4

When to Choose Alternatives

Botulinum toxin is preferred over baclofen for focal spasticity (e.g., post-stroke hand contractures, ankle spasticity) as it is more effective and better tolerated for localized applications. 2

Gabapentinoids (pregabalin, gabapentin) are first-line for neuropathic pain rather than baclofen, which has minimal supporting data for pain management outside spasticity. 2

Tizanidine offers equivalent efficacy with better tolerability, particularly less weakness, and may be preferred in patients requiring muscle relaxation without excessive sedation. 2, 4

Perioperative Management

Continue baclofen preoperatively, including the day of surgery, to avoid withdrawal—never abruptly discontinue in long-term users. 2