0357 Pimavanserin 34mg at Bedtime for Insomnia in Veterans with Post-traumatic Stress Disorder: Open-label Case Series

Abstract Introduction There is a critical need for effective and feasible interventions to address insomnia associated with post-traumatic stress disorder (PTSD). Several lines of evidence suggest that pimavanserin, 5-HT2A inverse agonist approved by the FDA treatment Parkinson's disease psychosis, may benefit PTSD-related sleep disturbances. We conducted pilot, open-label study pimavanserin 34mg at bedtime PTSD-associated preliminarily assess feasibility this intervention tolerability our protocol (NCT04188392). Methods Adult, male female Veterans chronic PTSD received fixed dose, open label pimavansern 6 weeks. Subjects completed 7 days actigraphy monitoring two consecutive in-lab polysomnograms (PSGs) pre-treatment. Safety adherence were assessed in-person weeks 3 otherwise weekly via telephone. Actigraphy closeout PSG repeated week 6. Primary outcomes recruitment retention rates, defined as total number subjects recruited into (goal n=6) completion rates 75%), respectively. Results A (mean age 35.3 [S.D. 6.3] years, 2 [33.3%] female, (33.3%] black or African American, Hispanic, 4 [66.7%] comorbid depression) over 5.8 months. One subject was found have mild OSA (AHI 5.6). Insomnia Severity Index (ISI) scores in severe range subjects. All (100%) treatment. no serious adverse events medication discontinuations due events. Preliminary analyses revealed greater tend toward improvement on subjective measures compared objective measures. Conclusion This case series provides preliminary protocol. larger, randomized controlled trial needed detect meaningful clinical difference severity following pimavanserin. Support (if any) Michael E. DeBakey VA Medical Center Seed & Bridge Award; Alzheimer's Neurodegenerative Diseases, Baylor College Medicine