Baclofen Administration Timing
For alcohol use disorders in patients with alcoholic liver disease, baclofen should be administered as 10 mg three times daily (morning, afternoon, and evening), which is the only dosing regimen tested in randomized controlled trials for this specific population. 1
Dosing Schedule for Alcohol Use Disorders
The standard regimen is 10 mg three times daily, totaling 30 mg/day, based on the only RCT conducted in patients with alcoholic cirrhosis. 1 This three-times-daily schedule was shown to improve total alcohol abstinence rates and decrease relapse over 12 weeks of treatment in patients with both compensated and decompensated cirrhosis. 1
- The total daily dose range for alcohol use disorders is 30-60 mg/day, divided into multiple doses throughout the day. 1
- Baclofen is the only AUD pharmacotherapy specifically tested in patients with advanced liver disease, making it uniquely suited for this population. 1, 2
Timing Considerations for Other Indications
For spasticity management (the primary FDA-approved indication), baclofen immediate-release formulations require three times daily dosing due to the drug's pharmacokinetics. 3, 4
- Modified formulations (sustained-release or gastric-retentive systems) allow once-daily dosing, typically administered in the morning, and have been shown to provide equivalent efficacy with better tolerability and reduced sedation compared to three-times-daily immediate-release formulations. 4
- When sedation is problematic with standard dosing, evening administration may be preferable to minimize daytime drowsiness, though this has not been formally studied in alcohol use disorder populations. 1
Critical Safety Considerations
Patients with hepatic encephalopathy should be excluded from baclofen therapy because the drug can significantly impair mentation, a side effect that becomes dangerous in advanced liver disease. 1, 2 The American Association for the Study of Liver Diseases specifically notes this contraindication based on the exclusion criteria used in the pivotal cirrhosis trial. 1
- Baclofen undergoes limited hepatic metabolism with primarily renal excretion, making dose adjustments necessary in renal dysfunction. 1
- Never abruptly discontinue baclofen as withdrawal can cause seizures, psychotic symptoms, and hyperthermia; these symptoms improve with drug reintroduction. 1, 3
- Careful monitoring for muscle weakness, urinary dysfunction, cognitive effects, and sedation is essential, particularly in elderly patients who rarely tolerate doses exceeding 30-40 mg/day. 1