An older man is seen in three stages of deep sleep. Behind him is the shape of a pill packet, with a crescent moon sitting in one of the circular pockets.

FDA Approves Belsomra® (suvorexant) to Treat Insomnia in People with Alzheimer’s

The US Food and Drug Administration (FDA) has approved an update for the use of the insomnia medication Belsomra® (suvorexant) C-IV. Belsomra originally received FDA approval for the general treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This update to the prescribing information adds the use of Belsomra for the treatment of insomnia in people with mild-to-moderate Alzheimer's disease (AD).1,2

Suvorexant is marketed as Belsomra®. It is manufactured by Merck, known as MSD outside the United States and Canada. The FDA granted this additional approval following a dedicated study of this insomnia medication in people with mild-to-moderate Alzheimer's disease.1

There are 5.8 million Americans diagnosed with Alzheimer's in the United States.3 There are 3 main stages of Alzheimer’s. Each one has different symptoms that signal the progression of the disease. One of the common symptoms is the disruption of sleep cycles. Sleep problems can change by stage.1

Sleep disturbance associated with Alzheimer’s

One of the signs of the mid-stage of AD is sleep difficulties or disturbances. Until now, lifestyle, a non-drug treatment, has been recommended as a way to reduce daytime sleepiness and napping. It is designed to reset a person’s internal clock and improve sleep routines.

Around 25 percent of people with mild-to-moderate Alzheimer’s dementia experience poor sleep and sleep rhythm disruptions. This number rises to 50 percent for those with severe dementia.2
Suvorexant offers people with Alzheimer’s a new approach for treating insomnia and other sleep problems. The FDA approval highlights the importance of targeted research on effectiveness in specific populations.1

Things to know about Belsomra

Belsomra received FDA approval in 2014 for the treatment of insomnia in the general population. Insomnia is a condition that describes difficulties with falling or staying asleep. Belsomra was the first in a new class of drugs targeting the brain chemical orexin. It is found in a specific area of the brain involved in regulating the sleep cycle.1

Drug trial findings

Merck conducted clinical trials specifically for the treatment of sleep disturbances in the Alzheimer’s population. The results of the Phase 3 targeted clinical study were published in Alzheimer’s & Dementia, the journal launched by the Alzheimer's Association. The four-week sleep study compared Belsomra to placebo. The results showed significant improvement in total sleep time and wake after sleep onset measures.1

Many insomnia drugs can lead to an increase in confusion and falls in people with cognitive impairment. The Belsomra study found that there were limited side effects for people with Alzheimer’s disease. The rate of falls in the group receiving Belsomra was 2 percent, while it was 0 percent in the placebo group. Also, 4.2 percent in the group receiving the medication experienced sleepiness the next day compared with 1.4 percent of those who got the placebo.2

There were 285 participants enrolled in the randomized double-blind study. The trials were placebo-controlled. They evaluated the drug on a similar number of men and women, 50-90 years of age.1-2

Dosing information

Belsomra contains suvorexant, a Schedule IV controlled substance.1 It is a first-in-class oral orexin receptor antagonist. Belsomra affects the central nervous system and the effects can last for up to several days after use.1

Proper dosing may require adjustments. Belsomra can have potentially additive effects if prescribed along with other other central nervous system (CNS) medications. The lowest possible amount should be prescribed.

People who take higher doses should use caution and avoid next-day driving and other activities that require full mental alertness.1

What are the possible side effects?

The most common side effects of Belsomra include the potential for:1

  • Impaired daytime wakefulness
  • Impaired driving skills
  • Increased risk of falling asleep while driving
  • Depression if used along with CNS depressants

If you take Belsomra, you should not drink alcohol or take CNS depressants because of the additive effects. Taking Belsomra may result in an increased risk of falling asleep while driving. Belsomra should not be taken by people with narcolepsy (daytime drowsiness and sudden attacks of sleep).1

This is not an exhaustive list of all potential side effects of Belsomra. Talk to your healthcare provider or pharmacist for further information.

The FDA approved updated prescribing information for this new use of Belsomra.

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