Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study

Abstract

Background/aims: Hypersomnia is common in dementia with Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability of armodafinil for hypersomnia associated with DLB.

Methods: 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.

Results: 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 (p < 0.001), Maintenance of Wakefulness Test (p = 0.003), and Clinical Global Impression of Change (p < 0.001) scores improved at week 12. The Neuropsychiatric Inventory total score (p = 0.003), visual hallucinations (p = 0.003), and agitation (p = 0.02) improved at week 4. Caregiver overall quality of life improved at week 12 (p = 0.004). No adverse events occurred.

Conclusion: 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.

Keywords: Caregivers; Excessive sleepiness; Lewy bodies; Quality of life; Treatment; Wake-promoting agents.

Figure 1

CONSORT Flow Diagram.

Figure 2

Changes in Daytime Hypersomnolence With Armodafinil. Box plots summarize group scores on the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) at baseline and week 12 of armodafinil treatment; individual patient scores are also shown (n=20). ISL indicates initial sleep latency.

Figure 3

Changes in Neuropsychiatric Inventory (NPI) Scores With Armodafinil. Box plots summarize group scores on the NPI total, apathy, visual hallucinations, and agitation scales at baseline and week 12 of armodafinil treatment; individual patient scores are also shown (n=20).