Evolving Expectations for Insomnia Treatments
Updated: Oct 18, 2019
Most of us have experienced insomnia - that terrible feeling when all you want to do is sleep but you lie awake. The occasional bout of insomnia may be caused by factors including stress, grief, and poor sleep hygiene. For example, many people work on their laptops in bed. Experts say doing this is counter to sleep hygiene, which are basically habits or practices that are necessary to have good nighttime sleep quality.
Chronic insomnia is typically not resolved with sleep hygiene and other non-pharmacologic approaches. It is defined as trouble initiating or maintaining sleep associated with daytime consequences, such as grogginess. When we worked on the launch of eszopiclone (Lunesta), there was excitement about there being a therapeutic option beyond zolpidem (Ambien) to help patients stay asleep. Since then, there have not been many developments in the treatment landscape for chronic insomnia. Many physicians have continued to prescribe therapies that are not indicated for the treatment of insomnia including Desyrel (trazodone). In 2014, suvorexant (Belsomra) was approved by the Food and Drug Administration (FDA). It was the first insomnia treatment with a novel mechanism of action as a dual orexin receptor antagonist (DORA). However, a higher more efficacious dose was not approved by FDA due to safety concerns, including next-day somnolence and effects on driving.
Lemborexant (Dayvigo) is a DORA expected to be approved by the FDA in 2020. Lemborexant has a favorable pharmacokinetic profile so it could help patients stay asleep and, of particular interest, it may ensure next day wakefulness. An impressive body of data includes a head-to-head trial with zolpidem and a next-day on-road driving performance study (https://www.eisai.com/news/2018/news201845.html). These studies support lemborexant’s lack of residual effects to help patients wake well. Since part of the definition of chronic insomnia includes daytime consequences, it is about time that these factors are taken into consideration when gauging the efficacy and safety of an insomnia treatment.