Researchers recently reviewed the evidence on this novel sleep aid’s performance in patients over the age of 65.

By Rose Rimler

Belsomra (suvorexant) is a novel insomnia drug manufactured by Merck that got some bad press shortly after its rollout in 2015. But according to a literature review presented at the American Association of Geriatric Psychiatry conference in March, the drug may be a good tool for treating insomnia in older patients. The researchers, led by Shilpa Srinivasan, MD, from the University of South Carolina, found seven studies that tested the drug in patients over the age of 65, including three randomized controlled trials. This small batch of data found the drug effective and safe in such patients, with no increased risk of falling or respiratory suppression reported, although some found themselves too sleepy to drive.

Falls are a risk for older patients on sleep aids. A review from Cardiff University found that patients over the age of 65 were more than twice as likely to fracture a hip shortly after taking benzodiazepines and z-drugs compared with patients not on such medications. Both benzodiazepines (Ativan, Valium, etc.) and z-drugs (Ambien, Lunesta, etc.) act on GABA receptors, which are plentiful and widely distributed throughout the brain. Belsomra, on the other hand, acts on receptors for a different neurotransmitter called orexin. Since there are many fewer orexin receptors in the brain, the drug’s effect is more specific and might therefore have fewer side effects. (Interestingly, a lack of orexin is thought to cause some types of narcolepsy.)

Although some Belsomra users did report somnolence, or sleepiness, that in and of itself doesn’t necessarily increase the risk of falling, says Joe Herring, MD, PhD, a neuroscientist at Merck who oversaw the drug’s development.

“Falls are really considered to be a relatively independent entity of just sleepiness. Drugs that actually impact balance would be more likely to cause instability that could result in falls and we don’t have an impact on balance,” he says. “And we also looked at our pooled phase 3 data both for elderly and non-elderly and we saw no increase in falls in our clinical trial experience.”

The FDA approved Belsomra in 2014 and the drug hit the market the following year. It was met with an icy media reception. Consumer Reports urged its readers to “skip” Belsomra, pointing out that patients in clinical trials taking FDA-approved doses gained just 6 minutes in sleep onset and 16 minutes in total sleep time. The Huffington Post and Health News Review criticized Merck’s ad campaign. And after Belsomra had been on the market for a little under a year, Consumer Reports reported on real-world patient side effects that had been filed with the FDA.

In its initial assessment of Belsomra, Consumer Reports encouraged its readers to stay away from sleeping pills all together. “Studies have also found that improving your sleep habits, such as relaxation training, setting and sticking to consistent bedtimes and wake-up times, regular exercise, quitting smoking, cutting back on caffeine and alcohol in the afternoon and evening, keeping your bedroom quiet and dark, and not watching TV or using computers in bed can help relieve insomnia.”

Steven Thau, MD, a New York-based physician who is not involved in Belsomra research, tells his patients something similar. “I am not a pill pusher by design,” he says. “I use the analogy that if I give you a fish you’ll eat for a meal, if I teach you to fish you’ll eat for a lifetime. If I give you a pill you’ll sleep for a night, if I teach you how to sleep you’ll sleep for the rest of your life.”

But he says there are certainly people who can benefit from sleep aids, and he has found Belsomra to work well in his older patients. “I prescribe it often….The things that are concerning for patients with other sleep agents, like feeling hungover, waking up confused or altered, I haven’t seen that with Belsomra. People wake up feeling pretty stable on their feet, without cognitive impairment.”

Ben Carter, PhD, co-author of the Cardiff study on hip fracture and sleep aids, sees Belsomra as a potential avenue for safer sleeping aids in older patients, but advises caution.

“[T]he research to date has been largely carried out on specific patient populations, most of which are not reflective of typical sufferers, so the research to date may not offer generalizability to the population as a whole,” he writes in an email. He encourages further research.

Merck is currently collaborating on clinical trials testing Belsomra’s effect on insomnia in patients with Alzheimer’s disease, Parkinson disease, multiple sclerosis, trauma-related insomnia, and more.

Rose Rimler is associate editor of Sleep Review.