FDA Approves Daridorexant (Quviviq) to Treat Insomnia

FDA Approves Daridorexant (Quviviq) to Treat Insomnia
Photo by Sander Sammy on Unsplash

In January 2022, the FDA approved daridorexant (Quviviq) to treat insomnia in adults. It’s expected to be available in May 2022.

Daridorexant is an oral tablet that you take about 30 minutes before bed. You should plan to devote at least 7 hours to sleep if you take daridorexant.

Daridorexant has very few common side effects, but it has several possible interactions. Discuss this with your healthcare provider and pharmacist before starting daridorexant.

From time to time, we all have trouble sleeping. But for more than 1 in 3 adults, these sleep troubles are more than just once in a while. Insomnia is one of the most common health conditions. And it’s become even more common in the past few years, due to the COVID-19 pandemic.

Medications are one way to treat insomnia. And there are many different sleep aids available. But many medications are better for helping you fall asleep than helping you stay asleep.

In January 2022, the FDA approved a new insomnia medication called daridorexant (Quviviq). This medication offers another treatment option for people who have trouble staying asleep.

Here, we’ll discuss everything you should know about daridorexant: how it works, its effectiveness, and what to expect should your healthcare provider prescribe it for you.

What is Quviviq (daridorexant)?

Daridorexant is an oral tablet that’s approved to treat insomnia in adults. It belongs to a group of medications called orexin receptor antagonists (ORAs). Daridorexant is in the same class as Belsomra (suvorexant) and Dayvigo (lemborexant). Daridorexant will be available in two strengths: 25 mg and 50 mg.

When available, daridorexant will be considered a controlled substance. This is because daridorexant carries a risk of addiction (more on this later). There will be limits on how often you’d be able to fill a prescription and how many pills you can fill at a time. Ask your pharmacist for more details on controlled substance limits, as they vary by state.

How does daridorexant work to treat insomnia?

ORAs are the newest class of insomnia medications. Your brain makes a “wake-up protein” called orexin every day. Orexin attaches to certain nerve cells when it’s time to wake up. When it’s time to sleep, orexin typically isn’t as active. Other sleep-promoting proteins are more active during that time.

As an ORA, daridorexant prevents from attaching to those nerve cells. This allows your brain to enter and stay in sleep mode. Once daridorexant wears off, your natural urge to wake up will kick back in.

How do you take daridorexant?

You should take one tablet of daridorexant about 30 minutes before bedtime. This medication takes longer to kick in if you take it with food. It’s important to only take daridorexant if you have at least 7 hours to devote to sleep. Waking up sooner than 7 hours after your dose could cause severe drowsiness.

The liver breaks down daridorexant. So if you have liver problems, your healthcare provider may recommend only taking the 25 mg strength. They may also suggest you avoid this medication altogether.

You should only take one tablet of daridorexant per day, regardless of the strength you’re taking. If your insomnia hasn’t gotten better after about a week of taking it, contact your healthcare provider. Daridorexant may not be the right option for you.

How effective is daridorexant?

Daridorexant is effective for helping people with insomnia fall and stay asleep. The FDA approved daridorexant based on three phase 3 clinical trials. Two of these studies looked at how effective the medication was over a 3-month period. The third study looked at long-term safety and side effects.

The first two studies compared daridorexant to a placebo (a pill with no medication in it). These studies showed that daridorexant significantly improved sleep compared to placebo. One of the two studies also showed that daridorexant 50 mg helped lower the amount of next-day sleepiness that’s common for people with insomnia.

How does daridorexant compare to other orexin receptor antagonists like suvorexant and lemborexant?

There are currently a lack of studies directly comparing any of the three FDA-approved ORAs. However, suvorexant clinical trials and lemborexant clinical trials reported similar effectiveness as daridorexant. Based on the available information, we can say all ORAs are effective insomnia treatments.

What are the known side effects of daridorexant?

Daridorexant was well-tolerated in clinical trials. The most common side effects people experienced were headaches and drowsiness. Some people also reported feeling dizzy or nauseous after their dose.

There are more serious risks to be aware of with daridorexant. But they are uncommon for most people if you take it as prescribed.

As mentioned earlier, daridorexant does carry a risk of addiction. This risk is lower than it is with other sleep medications. But if you have a history of substance use disorder, discuss this with your healthcare provider before starting daridorexant. This medication isn’t known to cause physical dependence or withdrawals.

Daridorexant can make it difficult to focus or complete tasks requiring attention. It can also cause grogginess the following morning for some people. Don’t drive unless it’s been at least 7 hours after your dose of daridorexant.

Daridorexant can cause depression or suicidal thoughts for some people. The risk of this is higher if you have a history of mental health conditions. If you experience any mood changes after starting daridorexant, contact your healthcare provider right away.

People have reported unusual behaviors and sensations during sleep while taking daridorexant. This includes sleep-walking, sleep-driving, and feeling like you can’t move or speak when first waking up (sleep paralysis). If any of these happen to you, discuss this with your healthcare provider.

Does daridorexant interact with other medications?

Yes, daridorexant interacts with many medications.

Daridorexant can cause drowsiness. So you should avoid taking other medications that cause drowsiness when possible. If the combination can’t be avoided, then discuss how to best separate these medications with your healthcare provider and pharmacist.

Daridorexant also interacts with the following:

  • Clarithromycin
  • Carbamazepine (Tegretol)
  • Grapefruit juice
  • Phenobarbital
  • Rifampin
  • St. John’s wort — an over-the-counter herbal remedy
  • Verapamil

These aren’t the only medications that interact with daridorexant. Always ask your healthcare provider and pharmacist to double check for interactions before starting anything new.

You should also avoid drinking alcohol while taking daridorexant. Alcohol can make you more likely to experience severe drowsiness or physical impairment. This can lead to serious injuries.

When will daridorexant be available?

Daridorexant is expected to be available in May 2022. Because it’s a controlled substance, the U.S. Drug Enforcement Administration (DEA) reviews this medication after the FDA. The DEA is required to conduct this review within 120 days (4 months) of the FDA’s approval of a controlled substance.

Summary

In January 2022, the FDA approved Quviviq (daridorexant) to treat insomnia in adults. This medication can be helpful both for falling and staying asleep. Studies suggest it’s both safe and effective.

Most people tolerated daridorexant well in studies. Headache and sleepiness are the most common side effects. But this medication has many potential interactions. Daridorexant should be available in May 2022.

Book an appointment for Free Video or Phone Consultation with our Pharmacist

References

American Academy of Sleep Medicine. (2020). What is insomnia?

Eisai Inc. (2021). Dayvigo [package insert].

Food and Drug Administration. (2022). NDA 214985.

Idorsia Pharmaceuticals US Inc. (2022). Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia.

Idorsia Pharmaceuticals US Inc. (2022). Quviviq [package insert].

Janto, K., et al. (2018). An update on dual orexin receptor antagonists and their potential role in insomnia therapeutics. Journal of Clinical Sleep Medicine.

Merck Sharp & Dohme Corp. (2021). Belsomra [package insert].

U.S. Government Publishing Office. (2014). Improving regulatory transparency for new medical therapies act.

Written by Christina Aungst, PharmD | Reviewed by Amy B. Gragnolati, PharmD, BCPS, Published on February 11, 2022
Tagged with: , , ,