Daridorexant

Daridorexant (Quviviq) is a prescription medicine used for insomnia to help adults fall asleep or stay asleep. Daridorexant tablets are taken regularly every night to help improve sleep over time. It is thought that daridorexant works by turning down overactive wake signals, by blocking a protein called orexin. Orexin makes you feel more awake, so blocking orexin helps improve sleeping. Orexin is from a class of medicines called dual orexin receptor antagonist (DORA).

Daridorexant FDA approval was received on January 10, 2022, for adults with difficulties going to sleep or staying asleep.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take daridorexant tablet 30 minutes before going to bed only once every night.

Only take daridorexant if you can stay at least 7 hours in bed before being active again.

If daridorexant is taken with or right after a meal, this medicine may take longer to work.

Call your doctor if your sleep problem worsens or does not improve within 7 to 10 days.

Keep your medicine in a place where no one can use it improperly.

Store at room temperature, away from moisture and heat.

Some people have thoughts about suicide while taking daridorexant. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Some people using daridorexant have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

You should not use daridorexant if you fall asleep often (narcolepsy).

Tell your doctor if you have ever had:

• mental illness, depression, or suicidal thoughts;
• drug or alcohol abuse or addiction;
• a condition called cataplexy (sudden onset of muscle weakness);
• daytime sleepiness;
• breathing problems, including sleep apnea (breathing that stops during sleep); or
• liver problems.

Pregnancy

It is not known if daridorexant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of daridorexant on the baby.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using daridorexant.

You should not take Daridorexant if you fall asleep often at unexpected times (narcolepsy). You should not take this medicine If you are allergic to daridorexant or any inactive ingredients in these tablets.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression, or have thoughts about suicide or hurting yourself.

Some people using daridorexant have engaged in activities such as driving, eating, walking, making phone calls, or having sex and later have no memory of the activity. Tell your doctor if this happens to you.

Call your doctor at once if you cannot move or talk for several minutes or if you have hallucinations while you are waking up or going to sleep.

Common side effects of daridorexant may include:

• headache; and
• drowsiness.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Daridorexant Dose for Insomnia:

• Recommended dose: 25 to 50 mg once per night, orally
• Maximum dose: 50 mg
• Comments: Take no more than once per night within 30 minutes of going to bed, and with at least 7 hours remaining prior to awakening. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric or medical illness that should be evaluated.
• Use: Treatment of adults with insomnia

Take the medicine as soon as you can. Do not take more than one dose on the same day. Skip the missed dose and go back to your normal dosing schedule if you will not be able to stay in bed for at least 7 hours after taking the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how daridorexant will affect you. Your reactions could be impaired.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Using daridorexant with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect daridorexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Ingredients

Active ingredient: daridorexant hydrochloride

Quviviq 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.

Quviviq is distributed by Idorsia Pharmaceuticals US Inc. One Radnor Corporate Center, Suite 101 100 Matsonford Rd Radnor, PA 19087