8 - Managing Sedation, Orthostasis and Tachycardia

Summary

In 2016 the United States Food and Drug Administration (FDA) added the category of falls as subsection 5.9 of the Warnings and Precautions listings for all antipsychotic package inserts. This mandated language reflected the concept that changes in blood pressure or alertness may not meet criteria for orthostatic hypotension or sedation as an adverse event during clinical trials, yet together they increase the risk of falling. Increased fall risk, especially among older patients, is one concern related to sedation and orthostasis when starting clozapine, but the other concern is that a patient will find tiredness or dizziness unacceptable when commencing treatment and refuse to continue with clozapine. Using case register data from the South London and Maudsley National Health Service Foundation Trust, it was found that 45% of 316 new clozapine starts from 2007 to 2011 discontinued clozapine within 2 years of initiation. Moreover, 52% of the discontinuations were due to patient decision, and adverse drug reactions were 2.6 times more likely to be the cause than dislike of laboratory visits.