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.
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.
Quviviq can cause sleep paralysis. This is the inability to move or talk for several minutes while waking up or falling asleep. You may also experience hallucinations while waking up or falling asleep. These can be vivid and scary. To decrease your risk for these side effects, try to keep a consistent sleep schedule and practice good sleep habits, known as sleep hygiene. Some examples of good sleep habits are to avoid using electronics in your bedroom, make your bedroom dark and quiet, and limit naps during the day. Avoid alcohol and recreational drug use, which can increase the risk for these side effects. Find ways to manage the stress in your life, since stress can trigger sleep paralysis or sleep-related hallucinations. Sleeping on your back is also linked to sleep paralysis, so trying to sleep in a different position may help. Talk to your health care provider if you experience sleep paralysis or hallucinations.
Quviviq may cause complex sleep behaviors that you may not remember the next day. Some examples include sleep walking, driving, making and eating food, making phone calls, and having sex while not fully awake. Take it as prescribed 30 minutes prior to bedtime, and stop your daytime activities soon after taking your dose. Staying up too long after taking sleep medicines may increase the risk for complex sleep behaviors. You should stop taking Quviviq immediately and talk to your health care provider if you experience any type of behavior like this.
Quviviq can worsen depression and cause suicidal thoughts and actions. Talk to your health care provider about your mental health history and current symptoms before taking Quviviq. Prioritize your mental health, and try to recognize and proactively manage depression triggers, like job loss or divorce. If you experience a life event that can trigger depression, talk to your health care provider to find ways to help you cope. Call your health care provider right away if you have any new or increased thoughts of suicide or death, suicide attempt, or new or increased feelings of anxiety, depression, or other unusual changes in mood or behavior.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Interactions With Foods and Other Medicines Can Happen?
Alcohol: Alcohol can increase the risk of side effects related to Quviviq, like excessive sleepiness and next-day drowsiness. You should not drink alcohol while taking Quviviq.
Medicines that cause dizziness or sleepiness: Medicines that cause drowsiness or sleepiness like prescription pain medicines, tricyclic antidepressants (even if it is not used for depression) and medicines for anxiety can increase the risk of side effects related to Quviviq, like excessive sleepiness and next-day drowsiness. Do not take these types of medicine with Quviviq without talking to your health care provider. The medicine doses may need to be adjusted, or you may not be able to take them at all. You should not take additional sleep medicines with Quviviq.
Inhibitors of cytochrome P450 3A4 (CYP3A4): Cytochrome P450 3A4 is a liver enzyme that processes and removes some medicines from the body. Taking CYP3A4 inhibitors (medicines that block the activity of CYP3A4) with Quviviq could increase the amount of Quviviq in your body, leading to excessive or dangerous side effects. Ask your pharmacist or health care provider if any of your medicines is a CYP3A4 inhibitor.
Inducers of cytochrome P450 3A4 (CYP3A4): Taking CYP3A4 inducers (medicines that increase the activity of CYP3A4) with Quviviq could decrease the amount of Quviviq in your body, causing it to work less well or not work at all. Ask your pharmacist or health care provider if any of your medicines is a CYP3A4 inducer.
Quviviq can also increase the levels of other certain other medicines. Tell your health care provider about all medicines you take.
This is not a complete list of medicines that may interact with Quviviq. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions with Quviviq or if you need a dosage adjustment.
Is Quviviq Addictive?
Clinical studies have not found Quviviq to cause physical dependence, which is when someone’s body gets used to a medicine or other substance and then “needs” it or they will experience unpleasant withdrawal symptoms.
How Can I Get Quviviq?
You will need a prescription from a health care provider like a primary care provider or a sleep specialist. You can get it at any pharmacy.
There is a savings card available from the manufacturer that may allow you to pay as little as $0 for your first prescription and $25 for refills. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.quviviq.com/savings.
