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Quviviq

Generic Name: daridorexant
Dosage Form: tablets, for oral use

Medically reviewed by A Ras.  Updated on  March 27, 2022.

What is Quviviq?

Quviviq is a prescribed medicine for adults who are having trouble getting asleep or remaining in bed (insomnia).

It isn’t clear whether this medication is suitable and safe to use in children.

Quviviq is a federally-controlled substance that is federally controlled (Schedule Pending) because it could be misused and result in dependence.

Make sure to keep Quviviq in a secure location to protect it from misuse and misuse. Giving away or selling this medication can cause harm to other people and is against the law.

Description

QUVIVIQ contains daridorexant, an orexin receptor antagonist. The chemical name of daridorexant hydrochloride is (S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride. The molecular formula is C23H23N6O2Cl * HCl. The molecular weight is 487.38 g/mol.

Quviviq (Daridorexant )

Daridorexant hydrochloride is a white to light yellowish powder that is very slightly soluble in water.

QUVIVIQ tablets are intended for oral administration. Each film-coated tablet contains 27 mg or 54 mg of daridorexant hydrochloride equivalent to 25 mg or 50 mg of daridorexant, respectively. The inactive ingredients are croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide.

In addition, the film coating contains the following inactive ingredients: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.

Mechanism of Action

Daridorexant

The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Important information

Quviviq may cause serious side effects, including:

  • A decrease in awareness and alertness. The morning following the intake of this medication the capacity to safely drive and be able to think clearly might be reduced. It is also possible to experience euphoria throughout the day.
    • Do not take any more this medication than the amount prescribed.
    • Do not use this medication unless you’re in a position to sleep for a whole night (at least seven hours) before you are physically active.
    • Take Quviviq in the evening, at least 30 minutes prior to going to go to bed.

Read about Qviviq’s side adverse effects for more details about the side effects.

Warnings and Precautions

  • CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases when used with another central nervous system (CNS)  depressants. For patients taking this medication, caution against next-day driving and other activities requiring complete mental alertness.
  • Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur.
  • Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of this medication.
  • Complex Sleep Behaviors: Behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if complex sleep behavior occurs.
  • Compromised Respiratory Function: Effect on respiratory function should be considered.

Who shouldn’t take Quviviq?

Avoid taking this medication when you sleep frequently at unplanned moments (narcolepsy).

Before taking Quviviq

Before taking this medication tell your physician about your medical issues, including the following:

  • are afflicted with depression, mental illness, or suicidal ideas or behaviors
  • Have a history of substance or alcohol abuse, addiction or addiction
  • Have a history of sudden beginning in muscles weakness (cataplexy)
  • Have a history of nighttime sleepiness
  • suffer from breathing or lung problems have breathing or lung problems, such as sleep apnea
  • Have liver issues
  • You are expecting or planning to get pregnant. It’s not clear whether this medication may cause harm to your baby.
    • Pregnancy Registry: There’s a registry of pregnant women who have been affected by this medication in pregnancy. The aim of this registry is to gather data on the health of both you and your child. For more information, or to be a part of the registry, contact 1-833-405-9611. Discuss with your doctor the risks for your unborn baby’s health when you are taking this medication during your pregnancy.
  • If you are nursing or planning to or plan to. It’s not clear whether this medication is absorbed into milk. Discuss with your healthcare professional the best method to feed your child while you are undergoing treatment.

What other drugs can have an effect on Quviviq?

Inform your doctor about every medicine you are taking such as prescription and over-the-counter medications such as vitamins, herbal supplements.

When you take this medication along with certain medications can cause serious adverse side adverse effects. this medication could affect the way other medications work, and different medications could affect how this medication functions.

Take care not to take this medication alongside other medications which can cause you to sleep unless your physician advises you to.

Other medications can influence this medication. Other medications can affect Quviviq, including prescription and non-prescription medicines as well as vitamins and herbal products. Inform your doctor about the medicines you are currently taking as well as any medications you are about to start or stop taking.

What is the best way to do it? Quviviq?

  • Use this medication exactly as the medical professional advises you to take it.
  • Do not alter the dose without first speaking to your doctor.
  • You should take Quviviq once at night, and within 30 minutes prior to going to bed.
  • Do not take Quviviq in the event that you are in bed for the entire night (at minimum seven hours).
  • Quviviq can have a longer time to kick in when taken with or after a meal.
  • Consult your physician Contact your healthcare provider if you experience insomnia (sleep issue) getting worse or has not improved within 7-10 days. This could indicate that there is another cause for sleep problems.
  • If you consume excessive amounts or are taking a high dose If you are experiencing an overdose or a dose of medication, contact your physician or go to the closest hospital emergency room immediately.

Dosing and administration

Recommended Dosage

The recommended dosage range is 25 mg to 50 mg of QUVIVIQ taken orally no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening).

Time to sleep onset may be delayed if taken with or soon after a meal 

Dosage Recommendations for Concomitant Use with CYP3A4 Inhibitors or CYP3A4 Inducers

  • Co-administration with Strong CYP3A4 Inhibitors
    • Avoid concomitant use of QUVIVIQ with strong inhibitors of CYP3A4
  • Co-administration with Moderate CYP3A4 Inhibitors  
    • The recommended dosage of QUVIVIQ is 25 mg no more than once per night when used with moderate inhibitors of CYP3A4
  • Co-administration with Strong or Moderate CYP3A4 Inducers   
    • Avoid concomitant use of QUVIVIQ with strong or moderate CYP3A4 inducers

Dosage Recommendations for Patients with Hepatic Impairment

The maximum recommended dosage in patients with moderate hepatic impairment (Child-Pugh score  7–9) is 25 mg of QUVIVIQ no more than once per night

QUVIVIQ is not recommended in patients with severe hepatic impairment (Child-Pugh score ≥ 10)

Dosage and strength

QUVIVIQ (daridorexant) tablets are available as:

  • 25 mg: light purple, arc-triangle shaped, film-coated tablet debossed with “25” on one side and “i” (Idorsia logo) on the other side, containing 25 mg daridorexant.
  • 50 mg: light orange, arc-triangle shaped, film-coated tablet debossed with “50” on one side and “i” (Idorsia logo) on the other side, containing 50 mg daridorexant.

What should I stay clear of while taking Quviviq?

  • Avoid drinking alcohol when taking Quviviq. It may increase your effects from alcohol which could be harmful.
  • It is possible to feel sleepy the next day following having taken Quviviq.
    • Don’t drive, operate machinery that is heavy, do things that are dangerous, or perform other tasks that require clear thought if you’ve taken Quviviq according to prescribed, but you are not feeling completely awake, have taken Quviviq but have had less than a complete night of rest (at least 7 hours) or if you have used more Quviviq that was recommended by your physician.

Quviviq side effects

Quviviq may cause serious side effects, including:

  • Check out Important details.
  • More severe depression and suicidal ideas. Get in touch with your healthcare professional immediately if you are experiencing any signs of depression that are getting worse or you have the thoughts of taking your own life or even dying.
  • Inability to move or speak (sleep paralysis) for up to a few hours, and hallucinations when you’re sleeping or getting up.
  • Heavy chest, nausea
  • Complex sleep patterns like sleeping-walking, driving, making and eating food or making calls, having sex, or engaging in other activities when asleep could be difficult to remember the next day. You should stop taking Quviviq and contact your physician immediately when you notice a recurring sleep-related behavior.

The most commonly reported adverse effects are headaches and insomnia.

This is not the only list of the possible adverse consequences. Contact your doctor for advice regarding medical possible side effects. You can report any side effects to the FDA via 800-FDA-1088.

How do I store Quviviq?

  • Keep Quviviq in a cool, dry place between 68degF and 77degF (20degC to 25degC).).
  • Make sure that all medications are away from pets and children.

General information on the safety of Quviviq.

Sometimes, medicines are used for reasons other than the ones listed in the Medication Guide. Use this medicine only for any medical condition for which it is not recommended. Don’t give it to others even if they suffer from similar symptoms as you do. It may cause harm to them. It is possible to seek advice from your doctor or pharmacist for advice specifically written specifically for healthcare professionals.

What are the ingredients of Quviviq?

Active ingredient: daridorexant hydrochloride
Inactive ingredients include croscarmellose sodium magnesium stearate, mannitol povidone, microcrystalline cellulose as well as silicon dioxide.
Its film is made up of the following components: glycerin, hypromellose iron oxide black and red iron oxide, microcrystalline cellulose, talc titanium dioxide, and in the tablet of 50 mg only the color of iron oxide are yellow.

More details

Always consult your doctor to confirm that the information provided on this site is appropriate to your particular situation.

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