Safety and Tolerability of Topical Clonazepam Solution for Management of Oral Dysesthesia

Publication date: Available online 11 May 2017
Source:Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Author(s): Michal Kuten-Shorrer, Nathaniel S. Treister, Shannon Stock, John M. Kelley, Yisi D. Ji, Sook-Bin Woo, Mark A. Lerman, Stefan Palmason, Stephen T. Sonis, Alessandro Villa
ObjectivesTo determine the absolute and relative safety of treatment with two concentrations of topical clonazepam solution (0.1 mg/mL, 0.5 mg/mL) for management of oral dysesthesia.Study designA retrospective chart review of patients diagnosed with oral dysesthesia and managed with topical clonazepam solution (swish and spit) between 2008 and 2015. The relative safety of the two concentrations was evaluated in terms of occurrence of adverse drug reactions (ADRs) and occurrence of change to treatment plan secondary to ADRs.Results162 subjects were included, 84 patients in the 0.1 mg/mL cohort and 78 in the 0.5 mg/mL cohort, evaluated at a median follow-up of 6 weeks. Thirty-eight (23%) patients developed ADRs. The most frequently reported ADR was sedation (62% of ADRs), followed by altered mental status and dizziness (7% each). Dose adjustments were required in nine patients (6%), and treatment discontinuation in thirteen (8%). ADRs were more frequently reported in the 0.5 mg/mL cohort, but no significant difference was found in terms of occurrence of ADRs, change to treatment plan secondary to ADRs, or types of ADRs (p>0.05).ConclusionTreatment with topical clonazepam solution in either 0.5 mg/mL or 0.1 mg/mL appears to be safe and well-tolerated. Future prospective studies are needed.



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