Maximum Baclofen Dose
The maximum recommended dose of baclofen is 80 mg per day, as specified by the FDA label and supported by multiple clinical guidelines. 1
Standard Maximum Dosing
The FDA-approved maximum daily dose is 80 mg (20 mg four times daily), typically achieved through gradual titration starting at 5 mg three times daily and increasing every 3 days until optimal effect is reached, usually between 40-80 mg daily 1
The 2018 EASL guidelines for alcohol use disorders specifically cite the French ANSM recommendation not to exceed 80 mg/day when using baclofen for alcohol use disorder treatment 2
Special Population Considerations
Older Adults
Elderly patients rarely tolerate doses greater than 30-40 mg per day due to increased risk of muscle weakness, urinary dysfunction, cognitive effects, and sedation 2
Start at 5 mg up to three times daily in older persons, with careful monitoring for adverse effects 2
Patients with Liver Disease
For muscle cramps in cirrhotic patients, the American Association for the Study of Liver Diseases suggests starting at 10 mg/day with weekly increases of 10 mg/day up to 30 mg/day 2, 3
Exercise particular caution in patients with advanced liver disease or hepatic encephalopathy due to risk of impaired mentation 3, 4
Standard dosing for alcohol use disorders in patients with liver disease ranges from 30-60 mg/day 4
Critical Safety Considerations
Never abruptly discontinue baclofen due to risk of central nervous system irritability and withdrawal symptoms 2, 1
The lowest dose compatible with optimal response should always be used 1
If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug 1
High-Dose Baclofen: Controversial Territory
While some research has explored doses exceeding 300 mg/day for alcohol dependence 5, and older studies confirmed safety of doses above the conventional 80 mg maximum 6, these high doses are not guideline-recommended and carry substantially increased risks. The evidence for high-dose baclofen remains controversial, with the largest study showing no superiority over placebo 2.
Common pitfall: Prescribing doses above 80 mg/day without recognizing this exceeds FDA-approved dosing and guideline recommendations. In older adults, even 40 mg/day may be excessive.