New Sleep Aid Belsomra Now Approved

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Belsomra (suvorexant) was approved by the FDA in August for patients with insomnia, including trouble falling and staying asleep.

When will Belsomra be available?
Belsomra is expected to be available in late 2014 or early 2015.

What type of medication is Belsomra?
Belsomra is the first drug in a new class of medications recently approved by the FDA known as orexin receptor antagonists. Many other current insomnia meds, including Ambien (zolpidem) are GABA agonists.

How does it work?
Belsomra inhibits the effect of orexin. Orexin is a chemical in the brain that plays a part in keeping you awake.

Want more information? Check out this article!

How is Belsomra usually taken?
Belsomra tablets have been approved in the following four strengths: 5 mg, 10 mg, 15 mg, 20 mg.

The recommended dose for Belsomra is 10mg once nightly within 30 minutes of going to bed when you are able to get at least 7 hours of sleep.

Are there any side effects?

The most commonly reported side effect of Belsomra is drowsiness.

Who should not take Belsomra?
Belsomra is not for anyone who experiences extreme daytime sleepiness and sudden irresistible episodes of sleep also known as narcolepsy.

Will Belsomra be a controlled substance like insomnia medications?

Yes. The DEA has proposed that Belsomra be controlled as a schedule IV substance, and it is undergoing review at this time.

Some other schedule IV controlled substances include Ambien (zolpidem), Xanax (alprazolam), Valium (lorazepam), and Soma (carisoprodol).

According to the DEA, schedule IV controlled substances are have a low potential for abuse and low risk of dependence.

Want more information?

You can also sign up for updates on Belsomra here.

Drugs featured in this story

Filed under