What is the recommended oral baclofen dosing and titration schedule for an adult with post‑stroke spasticity?

Baclofen Dosing for Post-Stroke Spasticity

For adults with post-stroke spasticity, start oral baclofen at 5-10 mg/day and titrate slowly every 2-5 weeks to a target dose of 30-80 mg/day divided into 3-4 doses. 1, 2

Initial Dosing Strategy

• Begin with 5-10 mg/day as the starting dose to minimize adverse effects including sedation, dizziness, and mental confusion 1
• Divide the total daily dose into 3-4 administrations throughout the day to maintain consistent therapeutic levels 1
• In elderly patients or those with renal impairment, mandatory dose reduction is required - start with the absolute lowest dose of 5 mg/day due to altered pharmacokinetics and potential 2-3 fold increase in drug half-life 1

Titration Schedule

• Increase doses by 5-15% every 24 hours for cerebral-origin spasticity (including stroke) in inpatient settings with daily assessment 3
• For outpatients who cannot return daily, use step dosing with increases every 2-5 weeks to reach the appropriate maximum dose 1
• Allow 4-8 weeks at maximum tolerated dose before declaring treatment failure 1

Target Therapeutic Range

• The typical effective dose range is 30-80 mg/day divided into 3-4 doses 1, 2
• Adverse effects typically appear at doses >60 mg/day, requiring careful monitoring as you approach this threshold 4
• Most patients achieve adequate spasticity control within this range without requiring higher doses 1

Treatment Algorithm Context

First-Line Non-Pharmacological Approaches (Try These First)

• Antispastic positioning, range of motion exercises, stretching, splinting, and serial casting should be initiated before or concurrent with baclofen therapy 1, 2
• These physical modalities have moderate evidence supporting effectiveness and should be maintained regardless of medication choice 2

When to Use Baclofen vs. Alternatives

• Baclofen is appropriate for generalized spasticity causing pain, poor skin hygiene, or decreased function 1, 2
• For focal spasticity (e.g., hand, ankle), botulinum toxin is superior to baclofen and should be used as first-line pharmacological intervention 1
• Alternative oral agents include tizanidine and dantrolene if baclofen is not tolerated 1, 2

Critical Safety Considerations

Monitoring Requirements

• Monitor renal function before initiating therapy, as baclofen is renally cleared and requires dose adjustment in impairment 1
• Assess patients within 24 hours of any dose change to evaluate response and adverse effects 3
• Check for CNS adverse effects including sedation, confusion, and excessive weakness at each visit 1

Oral Antispasmodic Weaning

• Wean oral antispasmodics one drug at a time, beginning with oral baclofen if the patient was on it previously, after ITB therapy begins (this principle applies when transitioning between spasticity medications) 3

Absolute Contraindications and Warnings

• Never abruptly discontinue baclofen in long-term users - taper slowly over weeks to avoid life-threatening withdrawal syndrome including seizures, hallucinations, delirium, fever, and potentially death 1
• Avoid benzodiazepines (e.g., diazepam) during stroke recovery as they have deleterious effects on neurological recovery 1, 2
• Use extreme caution with other CNS depressants due to additive sedation risk 1
• Baclofen may worsen obstructive sleep apnea by promoting upper airway collapse 1

When Oral Baclofen Fails

Intrathecal Baclofen Consideration

• Consider intrathecal baclofen for severe spasticity unresponsive to maximum oral doses (typically after trial of 80 mg/day) 1
• Intrathecal therapy requires only 1/100th of the oral dose for equivalent effect, with average maintenance doses of 268 μg/day for stroke patients 4, 5
• >80% of stroke patients show improvement in muscle tone with intrathecal therapy, and >65% have improvement in spasms 1, 5
• Intrathecal baclofen demonstrates significantly fewer and less severe spasms compared to oral baclofen in long-term comparative studies 6

Common Pitfalls to Avoid

• Do not titrate too rapidly - this is the most common cause of intolerable side effects leading to discontinuation (4-27% discontinuation rate with rapid titration) 4
• Do not use baclofen as first-line for focal spasticity - botulinum toxin is more effective for focal involvement 1
• Do not forget to adjust for renal function - failure to reduce doses in renal impairment leads to CNS toxicity 1
• Do not continue ineffective therapy indefinitely - if no response after 4-8 weeks at maximum tolerated dose, consider alternative treatments 1