34 research outputs found
Supplementary Material for: Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study
<p><b><i>Background/Aims:</i></b> Hypersomnia is common in dementia with
Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability
of armodafinil for hypersomnia associated with DLB. <b><i>Methods:</i></b>
We performed a 12-week pilot trial of armodafinil therapy (125-250 mg
orally daily) in DLB outpatients with hypersomnia. The patients
underwent neurologic examinations, a neuropsychological battery,
laboratory testing, electrocardiography, and polysomnography. Efficacy
was assessed at 2, 4, 8, and 12 weeks. Safety assessment included
laboratory examinations, QTc interval, and heart rate. Tolerability was
assessed by analysis of adverse events. Data were analyzed using the
last-observation-carried-forward method. <b><i>Results:</i></b> Of 20
participants, 17 completed the protocol. The median age was 72 years,
most of the participants were men (80%), and most had spouses as
caregivers. The Epworth Sleepiness Scale (<i>p</i> < 0.001), Maintenance of Wakefulness Test (<i>p</i> = 0.003), and Clinical Global Impression of Change (<i>p</i> < 0.001) scores improved at week 12. The Neuropsychiatric Inventory total score (<i>p</i> = 0.003), visual hallucinations (<i>p</i> = 0.003), and agitation (<i>p</i> = 0.02) improved at week 4. Caregiver overall quality of life improved at week 12 (<i>p</i> = 0.004). No adverse events occurred. <b><i>Conclusion:</i></b>
These pilot data suggest improvements in hypersomnia and wakefulness
and reasonable safety and tolerability of armodafinil therapy in
hypersomnolent patients with DLB. Our findings inform the use of
pharmacologic strategies for managing hypersomnolence in these patients.</p