The effect of sublingual atropine sulfate on clozapine-induced hypersalivation: a multicentre, randomised placebo-contro
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REVIEW
The effect of sublingual atropine sulfate on clozapine-induced hypersalivation: a multicentre, randomised placebo-controlled trial Omar Mubaslat 1,2
&
Tim Lambert 3
Received: 18 November 2019 / Accepted: 27 July 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Background Hypersalivation and drooling are commonly reported in clozapine-treated patients. Current management strategies have been evaluated using subjective measures. Many case reports describe the successful use of atropine in the treatment of the condition. Aims To measure the effect and safety of sublingual atropine on nocturnal unstimulated saliva secretion. Secondary aims were to evaluate the patient’s satisfaction with the atropine effect on hypersalivation (or sialorrhea), drooling, and sleep. Method Twenty-one clozapine-treated patients with hypersalivation, or drooling, were randomised to take a single 600-μg dose of sublingual atropine drops or a matching placebo. The saliva secretion was measured over 5 min at baseline and 2 h after the administration of the study medication. Results Sublingual atropine reduced the saliva secretion significantly more than the placebo (mean difference = − 57.21%, 95% CI: − 104.30, − 10.11, P = 0.02). A significant decrease in standing pulse rate was recorded in the participants in the atropine group (− 5.8 (− 9.54, − 2.15), P = 0.002). Subjectively, more patients in the atropine group found their pillow to have less saliva the following morning and found their sleep to be better. Conclusions Sublingual atropine drops significantly reduces nocturnal unstimulated clozapine-induced saliva secretion. More research is required to compare the effect of sublingual atropine with other anticholinergic medications and different dosage forms. Trial registration ACTRN12618000051246 Keywords Clozapine . Atropine . Hypersalivation . Drooling . Antipsychotic . Sialorrhea . Schizophrenia . Adverse Effect . Dysphagia . Saliva
Hypersalivation and drooling are serious adverse effects that are commonly reported in clozapine-treated patients. To date, no medication has been firmly established as the treatment of choice. Hypersalivation, defined here as the excessive production of saliva, is reported in 80% of clozapine-treated patients (Syed et al. 2008) while sialorrhea, another term that is used to describe clozapine effect on saliva secretion, was reported in
* Omar Mubaslat [email protected] 1
Missenden Mental Health Services, Royal Prince Alfred Hospital, Sydney, Australia
2
Department of Pharmacy, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050, Australia
3
Concord Clinical School, The University of Sydney, Sydney, Australia
33 to 48% of clozapine-treated patients (McEvoy et al. 2006; Liang et al. 2010). Sialorrhea is defined in the Stedman’s Medical Dictionary as the excessive flow of saliva without specifying the place of the flow. Hypersalivation increases the risk of the overspill of saliva from the mouth (drooling) with both a significant physical and
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