*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Quviviq, containing the active ingredient daridorexant, is a medication used to treat adults with insomnia. It is in a drug class called dual orexin receptor antagonists (DORAs), which reduce levels of the brain chemicals orexin A and B. These chemicals play a role in how awake or sleepy you feel. Quviviq is taken once daily at bedtime. Common side effects include daytime sleepiness and headache.
Quviviq is a controlled substance, which means that it’s more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.
What Is Quviviq (Daridorexant)?
Quviviq, with the active ingredient daridorexant, is an FDA-approved medication used to treat adults with insomnia (trouble falling or staying asleep). FDA approval indicates that the drug has been extensively tested and showed benefits for this use in patients.1
Quviviq is in a drug class called dual orexin receptor antagonists.1, 2 Quviviq reduces or blocks the effects of orexin A and B, which are brain chemicals that help regulate the sleep-wake cycle. There are some side effects you may experience when taking Quviviq, including daytime sleepiness and headache. There is no generic form of Quviviq.
How Does Quviviq Work?
Quviviq works by blocking the effects of brain chemicals called orexin A and orexin B.1 These chemicals normally help a person feel more awake. By blocking the effects of these chemicals, Quviviq helps you feel more tired or sleepy. This can help you fall asleep more quickly and stay asleep all night.
What Is Quviviq Used to Treat?
Quviviq is approved by the FDA for the treatment of insomnia.1 Patients who have insomnia may have trouble falling asleep and/or staying asleep all night. Some patients have both kinds of insomnia, which is called “mixed” insomnia.
How Effective Is Quviviq?
Quiviviq has been shown to be effective in treating insomnia in clinical trials. These studies show that for patients with insomnia, those who took Quiviviq showed improvement in the time to fall asleep and total sleep. This result was compared to patients who took placebo (no drug). Effects were seen with 25 and 50 mg doses, taken once at night. Improvement in time to fall asleep and total sleep time were observed after one and three months of taking Quviviq.1
The decision to use Quviviq for insomnia should be made based on each individual, taking into account the specific insomnia symptoms and other medical conditions that a person has.
How Long Does Quviviq Last?
For most people, the effects of Quviviq last all through the night (up to 7-8 hours).1 This is why you should only take Quviviq if you will have at least 7 hours in bed before you need to wake up and be active again. Some people may still feel drowsy the day after taking Quviviq. This is more likely to happen if you take a higher dose of Quviviq than prescribed, or if you do not have a full night of sleep after you’ve taken it.
Until you know how Quviviq affects you, avoid driving or other activities that require a lot of focus the day after you’ve taken Quviviq.
How Long Does it Take for Quviviq to Start Working?
Quviviq starts working in approximately 30 minutes for most people. It may take longer to work if you take it with a meal or soon after.1 You should only take Quviviq one time per night, within 30 minutes before bed.
How Long Do I Need to Keep Taking Quviviq?
You can take Quviviq once per night until your insomnia improves. If your insomnia does not improve or gets worse within 7 to 10 days, call your doctor. Quviviq has been studied in clinical trials in patients who took it nightly for up to 12 months and it was well tolerated and safe.3
Common Side Effects of Quviviq
Quviviq can cause side effects that commonly occur the day after taking it. These may impact how awake you feel, or make you dizzy or nauseous. Many of these wear off as the day progresses. If the side effects do not impact your ability to do normal activities, then they may not be a major concern. Medical care may be necessary if side effects persist, worsen, or are intolerable.
Common side effects of Quviviq include:1
- Daytime sleepiness or impairment
- Fatigue
- Headache
- Dizziness
- Nausea
*All medications, including Quviviq, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Serious Side Effects of Quviviq
Sometimes Quviviq may cause serious side effects that require immediate medical attention. Many serious side effects are related to activities that you would normally not do while sleeping, and others relate to worsening of mental health disorders. Development of severe side effects is often influenced by other factors, including ongoing mental health disorders, age, compromised lung function, and use of other drugs that are sedating.
Serious side effects of Quviviq may include:*1
- Sleep paralysis
- Sleepwalking
- Sleep driving
- Participating in normal non-sleep activities while not fully awake
- Hallucinations
- Mild cataplexy (sudden loss of muscle control)
- Worsening of depression
- Possible suicidal thoughts and actions
- Allergic reactions
*All medications, including Quviviq, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
What Are The Long-term Effects of Taking Quviviq?
At this time the long-term effects of Quviviq have not been extensively studied. In a clinical trial, Quviviq was well tolerated and generally safe in patients who took it for up to 12 months.3 You are unlikely to experience signs of physical dependance or “rebound” effects (worsening insomnia symptoms) after stopping Quviviq.
What Are the Risks & Warnings for Quviviq?
Risk of Depression or Suicidal Thoughts or Actions
Worsening of depression symptoms is possible with Quviviq. Also, Quviviq may increase or worsen suicidal thinking. This calls for immediate medical attention.
Risk of Misuse or Addiction
People who have a history of drug or alcohol addiction or abuse may be at higher risk of addiction or abuse of Quviviq.
Risk of Daytime Impairment & CNS-depressing Effects
Quviviq may cause impairment in the morning, and could impair muscle coordination and alertness. The day after taking Quviviq, patients should take caution with driving or other activities that require mental alertness.
Risk of Lung or Breathing Problems
Some studies have shown that Quviviq may decrease breathing or lung function. People with emphysema, COPD, asthma, or any other disease that impacts breathing should avoid taking Quviviq.
Risk for Those With Sleep Apnea
Quviviq may impact a person’s breathing during sleep, so people with sleep apnea should avoid taking Quviviq.
Risk for Those With Narcolepsy
Because Quviviq impacts a person’s ability to fall and stay asleep, patients who have narcolepsy (falling asleep at unexpected times) should not take Quviviq.
Possible Allergic Reactions to Quviviq
Do not take Quviviq if you’ve previously had an allergic reaction to it.
Risk of Unusual Sleep Behaviors
People taking Quviviq may have behaviors that they normally don’t do while sleeping, including walking and driving while asleep. Sleep paralysis or temporary loss of muscle control can also occur. Discuss these side effects with your doctor.
Risk During Pregnancy or Breastfeeding
Currently there is no information available to evaluate any potential harm from taking Quviviq during pregnancy or while breastfeeding.
There may be additional warnings or precautions with this medication. Talk with your healthcare provider about all the risks before you start taking this medication.
Drug Interactions With Quviviq
Quviviq can interact with other medications, supplements, herbs, and substances, which can be potentially harmful. To avoid any severe interactions, before you start taking Quviviq it is very important that you discuss all medications, supplements, herbs, and substances that you are taking with your healthcare provider. You may need to seek immediate medical care for these interactions.
6 substances you should avoid while taking Quviviq include:1
- Other medications for insomnia: Taking Quviviq at the same time as other drugs for insomnia may increase your risk of serious side effects.
- Foods and medications that affect CYP3A4 liver enzymes: Some foods and medications impact how well Quviviq is cleared from the body, which could make Quviviq less effective or could increase your risk of side effects.
- St. John’s wort: St. John’s wort is an herbal supplement that some people take for mild to moderate depression. This supplement can affect liver enzymes,so taking St. John’s wort with Quviviq can decrease the levels of Quviviq in the body and might make it less effective.
- Alcohol: Consuming alcohol can increase side effects of Quviviq, including drowsiness and sedation.
- Other central nervous system depressants: Taking Quviviq at the same time as other sedating medications can increase the risk of side effects from Quviviq, especially drowsiness and sedation. This includes (but is not limited to) opioids, benzodiazepines, and tricyclic antidepressants.
- P-glycoprotein (P-gp) substrates: Quviviq may impact how well other drugs called P-gp substrates work in the body. This may increase risk of serious side effects from the other drugs. There are many drugs that are P-gp inhibitors. Specific examples include some anticoagulants, heart medications, antibiotics, and HIV medications.
This is not a comprehensive list of the possible interactions with Quviviq. You should talk with your healthcare provider and your pharmacist about possible drug interactions before starting Quviviq.
Quviviq Dosages for FDA-Approved Treatment
The typical dose range of Quviviq is 25 to 50 mg, taken once nightly. Quviviq is approved for use in adults and is not approved for use in children and adolescents.1 Quviviq doses may be slightly different from person to person based on several factors including medical history, other medications, age, and weight.
Quviviq Forms & Strengths
Quviviq is available as an immediate-release oral tablet in strengths of 25 mg and 50 mg.
When a prescriber selects a dose for an individual patient, multiple factors are usually considered. These include the patient’s age, other medical conditions, and other medications they are taking. The 25 mg and 50 mg tablets will both take effect within 30 minutes.
Quviviq is available in the following forms and strengths:1
- 25 milligrams (mg) oral tablet
- 50 milligrams (mg) oral tablet
Quviviq Dosages for Adults With Insomnia
Quviviq dosages may vary depending on an individual’s response to the medication. Quviviq is taken one time per night, just before bedtime. It will take approximately 30 minutes for Quviviq to start working, and may take longer if it is taken with or very soon after a meal. It should only be taken if there are 7 hours available for sleep. Quviviq will likely be most effective when combined with good sleep habits and cognitive behavioral therapy.
Here is Quviviq dosage information for insomnia in adults:1
- Typical starting dosage: A typical starting dose for Quviviq is 25 mg to 50 mg one time per night.
- Dosage increases: A prescriber may recommend increasing the dose for some patients after careful evaluation of their condition and basic medical history.
- Maximum dosage: The typical maximum recommended dose of Quviviq is 50 mg daily.
How Should I Take Quviviq?
When taking Quviviq, follow the instructions exactly as your doctor or pharmacist has told you to take it. Quviviq is taken once per night, within 30 minutes before you go to bed. Only take Quviviq if you are able to stay in bed for a full night (at least 7 hours) before you are required to wake and be active again. Quviviq does not need to be taken with food. If you do take Quviviq with food (or just after you’ve eaten), it may take slightly longer to work.
Do not change your Quviviq dose without speaking with your healthcare provider. You should not take Quviviq with other medications that make you sleepy unless you have been instructed to do this by your doctor. Consuming alcohol while taking Quviviq may increase feelings of sleepiness and sedation.
What Happens If I Miss a Dose of Quviviq?
Quviviq should only be taken once per night. If you have missed a dose, you can take it as soon as you remember if you still have at least 7 hours remaining before you must get out of bed. If you have fewer than 7 hours remaining, then you should not take another dose until the following night.
Can You Overdose on Quviviq?
Yes, you can overdose on Quviviq. A Quviviq overdose may occur if you take more than the recommended dosage prescribed by your doctor. Signs and symptoms of an overdose of Quviviq include excessive sleepiness, fatigue, headache, attention disturbance, constipation, muscle weakness, sleep paralysis (inability to move when waking up from sleep), and sudden loss of muscle tone or control. If you suspect you have overdosed on Quviviq, call 911 for immediate medical attention.
What Should You Do If You Take Too Much Quviviq?
If you take too much Quviviq, you should immediately seek medical attention. You can call 9-1-1 to get immediate assistance and additional guidance. You should be prepared to give information about when you took Quviviq, how much you took, and general information about your medical history.
How to Get a Prescription for Quviviq
To get Quviviq, begin with an evaluation of your sleep issues. A good place to start for an evaluation like this is with your primary healthcare provider. Your provider may refer you to a specialist who can assess your insomnia symptoms and prescribe Quviviq, if they believe it is appropriate for you.
To get prescribed Quviviq online, you will also start by getting evaluated by an online provider. It is important to find an online platform that will do a virtual consultation and can prescribe controlled substances, such as Talkiatry and Circle Medical. Not all online providers offer this type of care and prescription options.
Frequently Asked Questions
Is Quviviq Safer Than Ambien?
Ambien and Quviviq have similar drug interactions and side effects (including serious side effects).1, 4 A large difference is that Ambien should be used for as short a time as possible. In clinical trials, participants taking Quviviq in the normal dosing range showed less impairment when compared to Ambien, with fewer overall side effects. Participants also reported lower “drug liking” scores when taking Quviviq compared to Ambien.4 Sleep paralysis may be more common with Quviviq than with Ambien.
Is Quviviq Better Than Lunesta?
In clinical trials, Lunesta and Quviviq have both been shown to be effective for people who struggle to fall and/or stay asleep. The side effects are similar for both drugs, though many of the side effects occur more frequently with Lunesta. Lunesta may cause some withdrawal symptoms if the dose is quickly decreased or stopped abruptly.1, 5
Is Quviviq Safe for Older Adults?
There is not usually a need to adjust the dose for adults 65 years of age or older.1 However, sleepiness and fatigue are more likely to occur in older adults taking Quviviq, which may increase the risk of falls. For this reason, lower doses of Quviviq may be appropriate for older adults.
Can Quviviq Be Used During Pregnancy or While Breastfeeding?
Pregnant or breastfeeding parents should not take Quviviq. Right now there is no information available to evaluate any potential harm from taking Quviviq during pregnancy or while breastfeeding.1
Questions to Ask Your Healthcare Provider About Quviviq
If you want to consider using Quviviq, talk to your primary healthcare provider to start the process of getting an evaluation. They already understand your health history and may be able to evaluate your insomnia symptoms. And if they think a sleep specialist would be helpful, they may make a referral. Alternatively, if you do not have a primary provider, an online platform offering insomnia treatment services can be a good place to start, such as Talkiatry and Circle Medical.
Questions to ask your care team about Quviviq include:
- How safe is Quviviq?
- What side effects are possible from Quviviq?
- Can I take Quviviq if I am already taking other medications?
- Can I use Quviviq with other medications that help me sleep?
- What is the best starting dose for me?
- How long will it take for me to get used to taking Quviviq?
- How will I know if my dose needs to be adjusted?
- When should I contact you if I experience side effects?
- How long do the side effects of Quviviq last?
- What should I do if I have an allergic reaction to Quviviq?
Prescriber’s Tips
Choosing Therapy strives to provide our readers with mental health content that is accurate and actionable. We have high standards for what can be cited within our articles. Acceptable sources include government agencies, universities and colleges, scholarly journals, industry and professional associations, and other high-integrity sources of mental health journalism. Learn more by reviewing our full editorial policy.
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DailyMed – QUVIVIQ – daridorexant tablet, film coated. (November 2, 2023). Dailymed.nlm.nih.gov. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
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Ufer, M., Kelsh, D., Schoedel, K. A., & Dingemanse, J. (March, 2022). Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem. Sleep, 45(3), zsab224. Retrieved from https://doi.org/10.1093/sleep/zsab224
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Kunz, D., Dauvilliers, Y., Benes, H., García-Borreguero, D., Plazzi, G., Seboek Kinter, D., Coloma, P., Rausch, M., Sassi-Sayadi, M., & Thein, S. (January, 2023). Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS drugs, 37(1), 93–106. Retrieved from https://doi.org/10.1007/s40263-022-00980-8
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AMBIEN CR. (February, 2022). AccessData.fda.gov. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf
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DailyMed – Lunesta – eszopiclone tablet, coated. (December 7, 2023). Dailymed.nlm.nih.gov. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
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