Daridorexant

What is daridorexant?

Marketed as QUIVIVIQ, daridorexant is a new tablet for treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Who can use daridoxerant?

• Daridorexant is used for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

How does daridoxerant work?

• Daridorexant is an orexin receptor antagonist

How is Daridorexant taken?

• Daridorexant is taken as an oral medication once a night before sleep.

What is the recommended dose of Daridorexant?

• The recommended dosage is 25 mg to 50 mg once per night taken orally within 30 minutes before 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.

What dosage adjustments are needed with liver impairement?

• Moderate hepatic impairment: Maximum recommended dosage is 25 mg no more than once per night.
• Severe hepatic impairment: Not recommended.

What are the dosage forms and strengths?

• Tablets: 25 mg, 50 mg.

Who should not use Daridorexant?

• QUVIVIQ is contraindicated in patients with narcolepsy.

What are the warnings and precautions of Daridorexant?

• CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment.
• Risk increases when used with other central nervous system (CNS) depressants.
• For patients taking QUVIVIQ, 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 use of QUVIVIQ.
• Complex Sleep Behaviors: Behaviors including sleepwalking, sleepdriving, 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.
• Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days.

What are the side effects of Daridorexant?

• The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue.

==How to report side effects of Daridorexant ?==

• To report suspected drug reactions, contact Idorsia pharmaceuticals
• Pharmaceuticals Ltd at toll-free phone 1-833-400-9611 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the drug interactions?

• Strong CYP3A4 inhibitors: Avoid concomitant use.
• Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg.
• Moderate or Strong CYP3A4 inducers: Avoid concomitant use.

How should I take QUVIVIQ?

• Take QUVIVIQ exactly as your healthcare provider tells you to take it.
• Do not change your dose of QUVIVIQ without first talking to your healthcare provider.
• Take QUVIVIQ one time each night, within 30 minutes before going to bed.
• Only take QUVIVIQ when you can stay in bed for a full night (at least 7 hours).
• QUVIVIQ may take longer to work if you take it with or right after a meal.
• Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days.

This may mean that there is another condition causing your sleep problem.

• If you take too much QUVIVIQ, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking QUVIVIQ?

• Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
• You may still feel drowsy the next day after taking QUVIVIQ.
• Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you have taken QUVIVIQ as prescribed but do not feel fully awake, you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed by your healthcare provider.

What is the most important information I should know about QUVIVIQ?

• Worsening depression and suicidal thoughts.
• Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
• Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
• Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.
• The most common side effects of QUVIVIQ include headache and sleepiness. These are not all of the possible side effects of QUVIVIQ.
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store QUVIVIQ?

• Store QUVIVIQ at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep QUVIVIQ and all medicines out of the reach of children. General information about the safe and effective use of QUVIVIQ.
• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use QUVIVIQ for a condition for which it was not prescribed. Do not give QUVIVIQ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about QUVIVIQ that is written for healthcare professionals.

What are the ingredients in QUVIVIQ?

• Active ingredient: daridorexant hydrochloride Inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide.
• The tablet film coating contains: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.

What studies are done?

• Lancet study

Manufacturer savings program

• Savings program - according to Quviviq.com, you pay as little as $0 for the first month and $25.00 thereafter for commercially insured patients. Restrictions might apply. Check with the manufacturer at Quviviq.com

How to get additional information?

• U.S. National Library of Medicine Daridorexant
• News on FDA approval

• Dailymed label info on Daridorexant
• FDA Daridorexant

Daridorexant Resources
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