Insomnia is highly prevalent in the older adult population. The pharmacolgical management of
chronic insomnia includes benzodiazepines and Z-drugs (zolpidem, zopiclone). Although these
drugs are indicated for insomnia, they are not without side effects. These drugs are
associated with cognitive impairment, rebound insomnia, falls and addiction. Mirtazapine has
a hypnotic and sedative effect related to the blocking of histamine-1 receptors. No clinical
trials has evaluated the efficacy and safety of mirtazapine for insomnia in the older
population.
The goal of the study is to assess the efficacy and safety of mirtazapine compared to a
placebo in older adults with chronic insomnia.
This prospective double-blind placebo controlled trial will be conducted in adults 65 years
and older with chronic insomnia. The treatment group will receive mirtazapine 7.5 mg at
bedtime for 28 days and the control group will receive a matching placebo for 28 days. The
sample size for the pilot study will be 60 subjects, 30 subjects in the treatment group and
30 subjects in the control group. The efficacy of mirtazapine will be measured using the
Insomnia Severity Index and the Pittsburgh Sleep Quality Index. Safety will be monitored
during the study