Testing Lemborexant as a Sleep Aid for Adults with Early-Onset Dementia and Insomnia in an Individual Trial

What this Trial Is About

Insomnia, a common and chronic condition, causes distress not only to patients but also to their caregivers and healthcare providers. Traditional sleeping aids like benzodiazepines and sedatives may cause side effects such as drowsiness, dizziness, cognitive impairment, and rebound insomnia, which are especially problematic in older, frail adults. This trial focuses on adults with early-onset dementia who experience insomnia, evaluating a newer medication called lemborexant, which may have fewer adverse effects than traditional sleeping aids. The trial uses an N-of-1 design over 8 weeks, where participants alternate between lemborexant and placebo in a specific sequence ABBABAAB, with doses of 5 mg and 10 mg of lemborexant during the active treatment weeks. Medications are provided in weekly packs with capsules masked to look the same for active and placebo treatments. There is no washout period between treatments. Participants will also use a reporting tool to record their sleep and any side effects. Participants and their caregivers will be contacted weekly by phone to report treatment effects and any adverse reactions. Daily measures include total sleep time, time to fall asleep, wake time after sleep onset, number of awakenings, and sleep quality. Quality of life for both patients and caregivers will be assessed weekly. Safety monitoring includes tracking adverse drug reactions and willingness to discontinue treatment due to side effects. The total study duration per participant is 8 weeks.

Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial