From the Guidelines
Baclofen should be initiated at a dose of 10 mg three times daily for the treatment of alcohol abuse, as this dosage has shown improved rates of total alcohol abstinence and decreased relapse in patients with alcoholic liver disease 1. The dosing of baclofen for alcohol abuse is crucial, and according to the most recent evidence, a 12-week course of baclofen at 10 mg three times daily has resulted in improved outcomes 1.
- Key considerations for baclofen dosing include:
- Starting dose: 10 mg three times daily
- Metabolism: Hepatic, with limited renal excretion
- Mechanism of action: GABA-B receptor agonist
- ALD considerations: Single RCT in patients with ALD showed benefit, but patients with hepatic encephalopathy were excluded due to potential impairment of mentation
- It is essential to monitor patients closely for side effects, such as drowsiness, dizziness, weakness, and nausea, and adjust the dose accordingly 1.
- Baclofen should be used as part of a comprehensive approach, including counseling and support groups, to ensure the best possible outcomes for patients with alcohol abuse 1.
From the Research
Dose of Baclofen for Alcohol Abuse
- The daily dose of baclofen used in studies for alcohol use disorder ranges from 30 mg to 300 mg 2, 3, 4, 5.
- A study found that baclofen 20 mg three times per day had a greater effect in reducing daily alcohol intake compared to 10 mg three times per day, showing a dose-effect relationship 4.
- Another study suggests that tailored doses of baclofen, which can be low or high depending on the individual case, may be effective in treating alcohol use disorder 5.
- The use of high doses of baclofen may be associated with severe adverse effects, but careful monitoring and prescription skills can help prevent these effects 5.
- Baclofen is not approved by the US Food and Drug Administration (FDA) for the treatment of alcohol use disorder, but it has received temporary approval in France 3, 6.
Efficacy of Baclofen
- Moderate-certainty evidence suggests that baclofen probably decreases the risk of relapse and increases the percentage of abstinent days in individuals with alcohol use disorder 2.
- High-certainty evidence found that baclofen increases the percentage of days abstinent, but there was no difference between baclofen and placebo in other primary outcomes such as heavy drinking days and number of drinks per drinking days 2.
- Baclofen may be particularly advantageous in individuals with liver disease due to its limited hepatic metabolism and safe profile in this population 3.
Safety and Adverse Effects
- Baclofen can cause adverse effects such as fatigue, dizziness, somnolence/sedation, dry mouth, paraesthesia, and muscle spasms/rigidity 2.
- High doses of baclofen may be associated with severe adverse effects, but careful monitoring and prescription skills can help prevent these effects 5.
- Baclofen therapy requires careful medical monitoring due to safety considerations, particularly at higher doses and in individuals with comorbid physical and/or psychiatric conditions 3.