Recommended Dosage for Baclofen
The recommended starting dose for baclofen is 5 mg three times daily, with gradual titration up to an optimal dose of 40-80 mg daily, not exceeding the maximum daily dose of 80 mg. 1
Initial Dosing and Titration
The FDA-approved dosing schedule for baclofen follows this titration pattern:
- 5 mg three times daily for 3 days
- 10 mg three times daily for 3 days
- 15 mg three times daily for 3 days
- 20 mg three times daily for 3 days 1
After this initial titration period, additional increases may be necessary, but the total daily dose should not exceed 80 mg daily (20 mg four times daily). The lowest dose compatible with an optimal response is recommended.
Special Considerations for Older Adults
For older adults, lower doses are typically required:
- Starting dose: 5 mg up to three times daily
- Maximum tolerated dose: Rarely tolerate doses greater than 30-40 mg per day 2
- Monitoring needed for: muscle weakness, urinary function, cognitive effects, and sedation
- Important: Avoid abrupt discontinuation due to risk of central nervous system irritability 2
Dosing in Liver Disease
For patients with liver disease:
- The presence of liver disease generally does not affect prescribing of baclofen at doses up to 80 mg/day 2
- However, a more gradual dose increase is recommended in cases of severe liver disease 2
Alternative Formulations
Once-daily formulations may be considered for improved compliance:
- Baclofen sustained release (SR) or gastric retentive system (GRS) can be administered once daily at the same total daily dose as immediate release formulation 3
- These formulations have shown equivalent efficacy to three-times-daily immediate release baclofen with better tolerance and reduced sedation 3
Specific Uses
For Alcohol Abstinence
- Baclofen has been shown effective in maintaining abstinence in patients with alcohol use disorder and liver cirrhosis 2
- Standard dosing applies (up to 80 mg/day) 2
For Spasticity
- The typical effective dose range is 40-80 mg daily 1
- Some patients with severe spasticity may require higher doses under close medical supervision 4
Important Precautions
- Always titrate gradually to minimize side effects
- Monitor for common adverse effects: drowsiness, dizziness, weakness, fatigue
- Abrupt discontinuation must be avoided as it can cause severe withdrawal symptoms including hallucinations, seizures, and rebound spasticity 1
- Blood levels may rise over time in patients with impaired renal function, requiring dose adjustment 4
The goal of baclofen therapy is to find the minimum effective dose that provides symptom relief while minimizing side effects. Regular assessment of efficacy and tolerability is essential for optimal treatment outcomes.