How were the trials designed?

The efficacy and safety of QUVIVIQ were assessed in adult and elderly patients who met DSM-5 criteria for insomnia disorder in two multicenter, randomized, double-blind, placebo-controlled studies. 

In Study 1, patients were randomly chosen to get either QUVIVIQ 25 mg, QUVIVIQ 50 mg, or placebo once nightly for 3 months. In Study 2, patients were randomly chosen to get either QUVIVIQ 10 mg, QUVIVIQ 25 mg, or placebo once nightly for 3 months. (The 10 mg dose is not an approved dose.) All the patients who got the same treatment (for example, all the patients who got the placebo pill) is called a treatment group.

In both studies, how well the drug worked was tested by comparing how much the sleep of the average patient in each treatment group changed from baseline (before getting treatment in the study) to Month 1 and Month 3. Sleep was checked by polysomnography (PSG) in a sleep laboratory at baseline, after 1 month of treatment and after 3 months of treatment. Polysomnography uses recordings of a person’s brain waves, oxygen levels, heartbeat, breathing, and eye and leg movements. An expert reads these recordings to see when they were awake or asleep. It was used to measure how long it took patients to fall asleep (called “Latency to Persistent Sleep”) and how much time they spent awake after first falling asleep (called “Wake After Sleep Onset”). To support the evidence from polysomnography, every morning, at home, patients also reported in a sleep diary how long they felt they slept the night before (called “subjective Total Sleep Time”).