Quviviq (also known as daridorexant) is a type of medicine called an orexin receptor antagonist that was approved by the FDA in 2022 to treat insomnia, or trouble sleeping. It can be used to treat people who have trouble falling asleep or those who have trouble staying asleep all night. It is available as a 25-milligram or 50-milligram tablet that you can take by mouth. It is taken within 30 minutes before going to bed and should only be taken when you plan on sleeping for at least 7 hours.
Quviviq works differently than a lot of other sleep medicines. While many other sleep medicines increase the sleepy signals in your brain, Quviviq suppresses wakeful signals instead.
Below you’ll find common questions and answers about Quviviq.
How Does Quviviq Treat Sleep Problems?
The exact cause of insomnia is not known. People with insomnia may have an imbalance of substances in the brain that cause them to feel awake compared to those that make them feel sleepy. Orexins are one of the substances in the brain that cause you to feel more awake. Quviviq is known as an “orexin receptor antagonist.” It blocks the wakeful effect of orexins, which leads to more sleep.
How Was It Studied?
Quviviq was studied in two very similar trials (Trial 1 and Trial 2) that included people with insomnia, or trouble sleeping. They were told to take either Quviviq or placebo pills (containing no medicine) once daily in the evening for 3 months. In Trial 1, the dose of Quviviq was either 25 milligrams or 50 milligrams. In Trial 2, the dose of Quviviq was either 10 milligrams (a dose that is not approved or available for use) or 25 milligrams. Since the 10-milligram dose is not available, this article will not focus on those results.
The average age of people in the trials was 55-57. Most were White (Trial 1: 90% and Trial 2: 88%), and more than half were females (Trial 1: 67.1% and Trial 2: 69%). People weren’t allowed in the trials if they had a history of suicidal thoughts or actions or if they napped frequently during the day.
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The trials measured how quickly people fell asleep and how long they stayed asleep before waking up. People in the study also recorded the total amount of time they slept each night in a diary. The trials measured the effect of Quviviq on sleep after 1 month of treatment and after 3 months of treatment.
After finishing these studies, people could choose to be in a longer, 9-month study (Trial 3). In the longer study, people were given either Quviviq or placebo pills. This trial’s main focus was making sure Quviviq was safe and did not have too many side effects.
What Benefits Were Seen for Treating Sleep Problems?
In Trials 1 and 2, people who took Quviviq fell asleep faster, stayed asleep longer, and slept more each night than those who took placebo pills. People started to improve within a week, and their total sleep continued to improve over the first several weeks of treatment.
How much faster did people who took Quviviq fall asleep?
- Trial 1: An average of 8-12 minutes faster with Quviviq
- Trial 2: An average of 6-9 minutes faster with Quviviq (This small difference may have been due to chance rather than the medicine.)
How much longer did people who took Quviviq stay asleep before waking up?
- Trial 1: An average of 12-23 minutes longer with Quviviq
- Trial 2: An average of 10-12 minutes longer with Quviviq
How much more sleep did people who took Quviviq get each night?
- Trial 1: An average of 10-22 minutes longer
- Trial 2: An average of 16-19 minutes longer
In Trial 3, Quviviq continued to work for the entire trial, which was 9 additional months (12 months total).
Your results may differ from what was seen in clinical studies.
What Side Effects Might Happen, and How Can I Prevent or Manage Them?
Quviviq can cause daytime sleepiness, which can affect alertness and coordination the day after or for several days after you take it. Do not drive or do other activities that require alertness or coordination until you know how it affects you. Always make sure to sleep a full night after taking Quviviq (at least 7 hours). Avoid taking extra Quviviq, since higher doses can make you feel sleepy for longer into the next day. Avoid drinking alcohol or taking other medicines that can cause drowsiness. This can help prevent sleepiness.