FREQUENTLY ASKED QUESTIONS
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Your Simtriyo[br-d] questions, answered
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What is the safety profile of Simtriyo in adults?
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Simtriyo established a consistent safety and tolerability profile across multiple adult clinical [br-m] trials.1,2
In pooled, 6-week, placebo-controlled studies, the most common adverse events occurring in ≥5% of adult patients treated with Simtriyo and greater than placebo were headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea. In adult studies of Simtriyo-treated patients, 6% taking 400 mg TDD and 5% taking 200 mg TDD discontinued treatment because of an adverse event, compared to 1% of placebo-treated patients. Compared to 1% of placebo-treated patients, 2% of Simtriyo-treated patients experienced anxiety.1
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Have studies assessed the effect of Simtriyo on sleep or cardiovascular health in adults?
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Simtriyo has class-related warnings for cardiovascular effects. In clinical trials, tachycardia was reported in 2% of adults compared with 1% of patients taking placebo, and there was no clinically meaningful effect on the QT interval.1 Insomnia incidence was 5% for patients taking 200 mg TDD and 7% for patients taking 400 mg TDD vs 4% for placebo.1,2
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Has the safety of Simtriyo for adult patients been studied over the long term?
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In a 52-week open-label extension study, Simtriyo demonstrated a safety and tolerability profile consistent with short-term studies, with no new safety findings and a low overall incidence of serious adverse events.3 The most common treatment-emergent adverse events were insomnia, nausea, diarrhea, and headache.3
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