Recommended Baclofen Dosing for Alcohol Abstinence
For alcohol abstinence, baclofen should be administered at a dose of 30-60 mg daily (typically 10 mg three times daily), with careful titration based on individual response and tolerability. 1
Dosing Protocol
Initial Titration
- Start with 5 mg three times daily for 3 days
- Increase to 10 mg three times daily for 3 days
- Increase to 15 mg three times daily for 3 days
- Increase to 20 mg three times daily for 3 days 2
Maintenance Dosing
- Standard effective dose: 30 mg daily (10 mg three times daily) 1
- Maximum recommended dose: 60 mg daily (20 mg three times daily) 1
- Duration of treatment: 12 weeks is the most studied duration 1, 3
Evidence for Efficacy
Baclofen is particularly valuable for alcohol abstinence in patients with alcohol-associated liver disease (ALD), as it:
- Effectively maintains abstinence by reducing alcohol craving 1
- Has demonstrated efficacy in randomized controlled trials specifically in patients with liver cirrhosis 1
- Likely reduces the risk of relapse to any drinking and increases percentage of abstinent days 3
- Shows a dose-response relationship, with 20 mg three times daily showing greater reduction in daily alcohol intake (68%) compared to 10 mg three times daily (53%) 4
Special Considerations for Liver Disease
Baclofen has distinct advantages in patients with liver disease:
- It is the only FDA-approved AUD pharmacotherapy tested in randomized controlled trials specifically in patients with alcoholic cirrhosis 1
- Unlike naltrexone, baclofen does not have hepatotoxicity concerns 1
- Unlike disulfiram, baclofen is considered safe in patients with liver disease 1
Safety Considerations
- Patients with hepatic encephalopathy were excluded from trials, as baclofen may impair mentation 1
- Monitor for CNS side effects, which may be increased in hepatic impairment 5
- Common adverse effects include fatigue, dizziness, somnolence/sedation, dry mouth, paraesthesia, and muscle spasms/rigidity 3
- Abrupt discontinuation can lead to severe withdrawal symptoms; always taper gradually 5
Clinical Pearls
- Patients with alcohol dependence may have blunted sensitivity to baclofen, potentially explaining why higher doses are sometimes required 6
- Some patients may require higher doses (>60 mg/day) for full symptom suppression, though tolerability decreases at higher doses 7, 8
- Baclofen appears to be more effective in heavy drinkers compared to those with lower baseline alcohol consumption 8
- Psychosocial support should be provided alongside pharmacotherapy for optimal outcomes 1
Monitoring
- Assess for clinical response (abstinence, reduced cravings)
- Monitor for adverse effects, particularly sedation and confusion
- Evaluate liver and kidney function periodically
- Ensure patient adherence to medication and abstinence program
This evidence-based approach to baclofen dosing provides a structured protocol for managing alcohol abstinence, particularly in patients with alcohol-associated liver disease where other pharmacotherapies may be contraindicated.