Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
Status:
Recruiting
Trial end date:
2028-12-11
Target enrollment:
Participant gender:
Summary
Insomnia is a highly common, chronic disorder that is distressful for the patient but also
for caregivers and can give rise to a heavy burden on the healthcare team. Sleeping aids like
benzodiazepines and other sedatives (e.g., zolpidem, zopiclone) have been widely used to help
treat insomnia. However, sleeping aids are also known to cause adverse drug reactions such as
drowsiness and dizziness, that increases the risk of falls, driving impairment, visual
impairment, cognitive impairment, and upon discontinuation may cause paradoxical rebound
insomnia, delirium, and nightmares all of which exacerbate the initial insomnia. All of the
negative aspects of sleeping aid use are exaggerated for older, frail adults.
Some patients experience an early (young-age) onset dementia with a substantial component of
insomnia. Due to the many risks associated with traditional sleeping aids they are often
inappropriate in adults living with cognitive impairment and/or frailty. Lemborexant comes
from a new class of medications for insomnia. Lemborexant is a dual orexin receptor
antagonist that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to
their receptors orexin 1 receptor (OX1R) and orexin 2 receptor (OX2R), which is thought to
suppress wake drive. Unlike other traditional sleeping aids, lemborexant has not shown to be
significantly associated with driving impairment, rebound insomnia, or dependence/withdrawal
symptoms. Also, in clinical trials it only rarely causes the types of adverse events
associated with benzodiazepines and other traditional sedatives and is less often associated
with discontinuations due to adverse events.
While lemborexant is available on the Canadian market it is unclear how this medication will
be tolerated by patients living with an early onset dementia. Understanding the effectiveness
and tolerability of lemborexant will be helpful in an N of 1 trial to understand the details
of effect and effectiveness in individual patients.