Baclofen for alcohol dependence: Relationships between baclofen and alcohol dosing and the occurrence of major sedation

The dose-effect relationship of baclofen in alcohol dependence: A 1-year cohort study

“…They did not receive any other anticraving treatment. Detailed materials and methods have been previously reported ( Rolland, Labreuche, et al, ; Rolland, Valin, et al, ) . Noninclusion criteria were other current substance use disorders, except for tobacco dependence, and any current DSM‐IV‐TR Axis I diagnosis (Rolland, Deheul, Danel, Bordet, & Cottencin, ).…”

Moderation of baclofen response by a GABAB receptor polymorphism: results from the BacALD randomized controlled trial

“…Participants with the rs29220 G– genotype also reported a greater frequency of dizziness than CC carriers. These results are interesting, given that increasing doses of baclofen may be associated with a range of adverse events , and its use has been recommended to be limited to specialist settings . However, given the sample size and relatively high prevalence of dizziness in the placebo group, these results should be interpreted cautiously.…”

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence

“…A wide range of side effects of mostly mild intensity were reported by 88% of patients, with no relationship between side effects and treatment response. In another prospective cohort study [146] involving 253 patients treated for up to one year, episodes of major sedation were recorded and the relationship between them investigated using a generalised estimating equation (GEE) model. The rate of sedation episodes increased with levels of alcohol and baclofen daily dose separately, and showed a significant interaction between the two.…”

“…However RCTs typically exclude patients withsignificant physical or psychiatric comorbidity [100] which obscures potential safety concerns in the wider group of patients seen in clinical practice. In patients with alcohol dependence especially, any medication to initiate abstinence or reduce drinking needs to have good evidence for the safety of the drug combined with alcohol, which seems well established for nalmefene [132] but less clearly for baclofen [146]. For medications that aim to promote abstinence from alcohol the safety profile needs to be weighed against the risks to the patient of relapse [112], but the prescriber also needs to take into consideration potential interactions with concomitantly prescribed medications in a patient group with considerable physical and psychiatric comorbidity.…”