They were told that, unless they have no unbearable side effects, they must continue to increase the dose of baclofen, with no given limit of dosage, as long as they have episodes of craving for alcohol.
After reaching a dose of 120–150 mg/day, if these doses were ineffective, or not sufficiently effective, patients were asked to actively participate in the dose increase. The treatment was conducted similarly for all patients doses were progressively increased (one additional 10 mg-tablet every 3 days) until a state of indifference toward alcohol (suppression of craving) was reached. This means that, according to this cohort, 17% of alcohol-dependent patients need more than 300 mg/day of baclofen for their treatment (and nearly one in four needs at least 300 mg/day). Among the 100 charts, it appeared that 17 patients have been taking doses of baclofen superior to 300 mg/day at 1 time or another during their treatment (7 other patients reached the dose of 300 mg/day without exceeding it). At the time of the review (July 2014), all the patients except one (see Patient-14 below) were under the care of the author (last visit posterior to May 2014). The charts of the last 100 patients, followed for at least 6 months, were reviewed.
Since 2008, the author has prescribed baclofen to approximately 600 alcohol-dependent patients. The present report is an analysis of the author’s medical charts of patients taking, or having taken, very high doses of baclofen, i.e., more than 300 mg/day for the treatment of their alcohol dependence. Recently, the French Health Safety Agency released a recommendation allowing for the prescription of baclofen to be given up to 300 mg/day, but not beyond, for the treatment of alcohol dependence (French Ministerial decree of June 13, 2014).
Drug summaries recommend not exceeding the daily dose of 75–80 mg (75–80 mg/day) ( 2, 3) although long-term studies have shown that doses exceeding 250 or 300 mg/day are often necessary to produce a state of complete indifference to alcohol ( 4, 5). However, the question of the upper limit of baclofen dosage that may be reached is a matter of discussion. High-dose baclofen has been shown to produce a remarkable state of indifference toward alcohol ( 1).