From the FDA Drug Label
The total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.). The maximum daily dose of baclofen (Lioresal) is 80 mg daily.
- The dose can be divided into four equal doses of 20 mg every 6 hours. 1
From the Research
The maximum daily dose of baclofen for ALS patients is typically 80-100 mg per day, divided into multiple doses. Treatment usually starts with a low dose of 5-10 mg three times daily, gradually increasing by 5-10 mg every 3-7 days until optimal symptom control is achieved or side effects become limiting. Some patients may require and tolerate higher doses up to 120 mg daily in severe cases, but this should only be done under close medical supervision, as seen in a study on high dose oral baclofen therapy 2. Baclofen works by activating GABA-B receptors in the spinal cord, reducing the release of excitatory neurotransmitters and thereby decreasing muscle spasticity that commonly affects ALS patients. Side effects to monitor include drowsiness, weakness, dizziness, and confusion, which may be more pronounced in ALS patients due to their underlying neurological condition. Abrupt discontinuation should be avoided as it can cause withdrawal symptoms including hallucinations, seizures, and rebound spasticity. Regular assessment of therapeutic benefit versus side effects is essential to determine the optimal individualized dose.
Key considerations for baclofen dosing in ALS patients include:
- Starting with a low dose and gradually increasing as needed and tolerated
- Monitoring for side effects and adjusting the dose accordingly
- Being aware of the potential for withdrawal symptoms with abrupt discontinuation
- Considering the use of higher doses in severe cases under close medical supervision, as supported by studies such as 2 which confirmed the safety and efficacy of high dose baclofen.
It's also important to note that the pharmacokinetics of high dose baclofen may vary from those described previously, with time-to-peak plasma levels and plasma half-lives potentially being longer than expected, as noted in 2. This highlights the importance of individualized dosing and monitoring in ALS patients.