Quviviq: Uses, Side Effects and Dosage

What is QUVIVIQ used for?

QUVIVIQ is used in adults who have trouble falling asleep and/or staying asleep (insomnia).

QUVIVIQ is not for use in children under the age of 18 years.

How does QUVIVIQ work?

QUVIVIQ contains daridorexant. Daridorexant belongs to a group of medicines called orexin receptor antagonists. Orexins are substances that bind to certain receptors in your brain to keep you awake. QUVIVIQ temporarily blocks these receptors. This may help you fall asleep faster and stay asleep.

What are the ingredients in QUVIVIQ?

Medicinal ingredient: daridorexant (as daridorexant hydrochloride)

Non-medicinal ingredients: croscarmellose sodium, glycerin, hypromellose, iron oxide black, iron oxide red, iron oxide yellow (50 mg tablets only), magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, talc, and titanium dioxide.

QUVIVIQ comes in the following dosage forms:

Film-coated tablets: 25 mg and 50 mg

Do not use QUVIVIQ if:

• you are allergic to daridorexant, or any of the other ingredients of QUVIVIQ (see What are the ingredients in QUVIVIQ?).
• you have narcolepsy, a sleep disorder that causes excessive daytime sleepiness and causes you to fall asleep often at unexpected times.
• you are taking a strong CYP3A4 inhibitor. Talk to your healthcare professional if you are unsure.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take QUVIVIQ. Talk about any health conditions or problems you may have, including if you:

• have a history of depression, mental illness, or suicidal thoughts or attempts.

• have a history of problems with drugs or alcohol.

• are taking other medicines including central nervous system depressants used to treat insomnia, anxiety, panic attacks, and seizures.
• drink or plan to drink alcohol. Do not drink alcohol in combination with QUVIVIQ.
• have liver problems.
• have severe lung or breathing problems including severe sleep apnea and severe Chronic Obstructive Pulmonary Disease (COPD).

• are pregnant or plan to become pregnant. It is not known if QUVIVIQ can harm your unborn baby. Your healthcare professional will decide whether giving you QUVIVIQ outweighs the risk to your unborn baby.

  • Pregnancy Registry: There is a pregnancy registry for women who are exposed to QUVIVIQ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-833-957-3925.

• are breast-feeding or plan to breast-feed. A small amount of QUVIVIQ can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you take QUVIVIQ.
• have thyroid problems.
• are 65 years of age or older.

Other warnings you should know about:

Need to check for other existing medical conditions: Sleep problems can be a sign of many physical and mental disorders. Your healthcare professional will need to check your medical history before you start taking QUVIVIQ.

Talk to your healthcare professional if after 7 to 10 days of taking QUVIVIQ your sleep problems:

• do not stop or do not get better.
• get worse or you develop new abnormal thinking or behaviour.

This may mean that there is another condition such as a physical or mental illness causing your sleep problems.

Complex sleep-related behaviours: While taking a sleep medication, such as QUVIVIQ, you may get out of bed while not being fully awake and do activities that you do not know you are doing, such as:

• sleepwalking.
• driving a car (“sleep driving”).
• eating.
• making phone calls.
• having sex.

The next morning you may not remember what you did during the night. If someone tells you about events you do not remember doing, or you think you may have done things in your sleep you do not remember doing, stop taking QUVIVIQ and call your healthcare professional. You increase your risk of doing activities while not fully awake if you:

• drink alcohol.
• take other medicines that make you feel sleepy.
• have other conditions that affect your sleep that can cause you to wake up often during the night (such as sleep apnea, Periodic Limb Movement Disorder or Restless Leg Syndrome).

Sleep paralysis, muscle weakness (cataplexy), and hallucinations: You may experience the following when taking QUVIVIQ:

• you are not able to move or talk for up to several minutes while you are going to sleep or waking up (sleep paralysis).
• have sudden muscle weakness, commonly in the legs, that can last a few seconds to a few minutes (cataplexy-like symptoms).
• seeing or hearing things that are not there (hallucinations) while falling asleep or when you wake up.

If you experience any of these, talk to your healthcare professional.

Worsening depression and thoughts of suicide: Some people with depression who took sleep medication saw their depression get worse and had increased suicidal thoughts and attempts. Thoughts of suicide have been reported in people taking QUVIVIQ. If you, your caregiver or your family members notice that your depression is getting worse or that you are having thoughts of suicide call your healthcare professional right away.

Mental alertness, driving, and using machines: QUVIVIQ may affect your ability to be alert the next day. It may affect how well you drive and you may be at an increased risk of falling asleep while you drive. Do NOT drive, do activities that require you to be alert, or use dangerous machinery until you know how taking QUVIVIQ affects you the next day.

You can feel less alert:

• even if you take QUVIVIQ exactly as prescribed.

You increase the risk of being less alert the next day if:

• you do NOT get a full night of sleep (at least 7 hours)
• you take QUVIVIQ with other medicines that make you sleepy
• you are taking a higher dose than your healthcare professional prescribed

If you notice that you are feeling more sleepy or drowsy during the day and it is affecting your ability to do tasks that require clear thinking or attention, talk to your healthcare professional.

Falls: Since hypnotics such as QUVIVIQ can cause you to feel drowsy, you may be at a higher risk of falls, especially if you are older.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with QUVIVIQ:

• alcohol
• medicines used to treat insomnia, anxiety, panic attacks, and seizures called central nervous system depressants
• diltiazem, used to treat high blood pressure and chest pain/angina
• itraconazole, used to treat fungal infections
• efavirenz and ritonavir, used to treat HIV
• rifampin and clarithromycin, used to treat bacterial infections
• midazolam, used to cause drowziness and relieve anxiety
• tacrolimus, used to prevent organ transplant rejection
• high doses of simvastatin, used to treat high blood cholesterol
• dabigatran etexilate, used to prevent and treat blood clotting
• digoxin, used to treat various heart conditions
• grapefruit and grapefruit juice
• St. John’s wort, a herbal remedy

How to take QUVIVIQ:

• Take QUVIVIQ exactly as your healthcare professional tells you.
• Take it at night within 30 minutes before going to bed. Only take QUVIVIQ when you can get a full night of sleep (at least 7 hours).
• QUVIVIQ may take longer to work if you take it with or soon after eating a meal.

Usual dose:

Your healthcare professional will tell you how much to take. Your dose will depend on your health and other medications you are taking.

Overdose:

Missed Dose:

If you miss a dose and

• you can get at least 7 hours of sleep before you must be active again, take your dose as usual.
• you cannot get at least 7 hours of sleep before you must be active again: do NOT take your dose. Take it the next night within 30 minutes before going to bed.

What are possible side effects from using QUVIVIQ?

These are not all the possible side effects you may have when taking QUVIVIQ. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effect of QUVIVIQ is headache.

Other possible side effects of QUVIVIQ may include:

• Dizziness
• Feeling tired
• Nausea
• Nightmares
• Abnormal dreams

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store QUVIVIQ at room temperature (15 – 30 °C).
• Keep out of reach and sight of children.

If you want more information about QUVIVIQ:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.idorsia.ca), or by calling 1-888-646-1764.

QUVIVIQ® is a trademark of Idorsia Pharmaceuticals Ltd.

Last Revised NOV 08, 2024