Label: information for the patient

QUVIVIQ 25 mg film-coated tablets

QUVIVIQ 50 mg film-coated tablets

daridorexant

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

QUVIVIQ contains the active ingredient called daridorexant, which belongs to a class of medicines called «orexin receptor antagonists».

QUVIVIQ is used to treat insomnia in adults.

How QUVIVIQ works

Orexin is a substance produced by the brain that helps keep you awake. By blocking the action of orexin, QUVIVIQ allows you to fall asleep more quickly, sleep for longer, and improve your ability to function normally during the day.

Do not take QUVIVIQ

• If you are allergic to daridorexant or any of the other components of this medication (listed in section 6).
• If you have narcolepsy, a condition that causes you to fall asleep suddenly and unexpectedly at any time.
• If you are taking medications that may increase the levels of QUVIVIQ in your blood, such as:
• Oral medications for fungal infections, such as ketoconazole, posaconazole, voriconazole, itraconazole.
• Certain medications for bacterial infections, such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin.
• Certain medications for HIV infection, such as ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir.
• Certain medications for cancer, such as ceritinib, idelalisib, ribociclib, tucatinib.

Consult your doctor if the medication you are taking prevents you from taking QUVIVIQ.

Warnings and precautions

Consult your doctor or pharmacist before starting to take QUVIVIQ:

• If you have depression or have had suicidal thoughts
• If you have a psychiatric disorder
• If you are taking medications that affect the brain, such as treatments for anxiety or depression
• If you have consumed drugs (except as medications) regularly or have been addicted to drugs or alcohol
• If you have liver problems: depending on their severity, QUVIVIQ may not be recommended, or a lower dose may be necessary.
• If you have breathing difficulties (such as severe chronic obstructive pulmonary disease)
• If you have a history of falls and are over 65 years old (because the risk of falling is generally higher in patients >65 years old).

Your doctor may want to monitor how the medication affects you.

Talk to your doctor if you experience any of the following side effects while taking QUVIVIQ:

• Sleep paralysis: temporary inability to move or speak for several minutes when waking up or falling asleep
• Alucinations: seeing or hearing vivid or disturbing things that are not real when waking up or falling asleep

If you have depression and experience a worsening or have thoughts of self-harm, call your doctor immediately.

Children and adolescents

This medication is not for children and adolescents under 18 years old because QUVIVIQ has not been tested in this age group.

Other medications and QUVIVIQ

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication because:

• Some antibiotics (erythromycin, ciprofloxacin, clarithromycin, rifampicin), immunosuppressants (ciclosporin), antifungals (itraconazole), cancer treatments (ceritinib) or HIV treatments (ritonavir, efavirenz) may increase or decrease the amount of QUVIVIQ in the blood. Some of these medications may be contraindicated with QUVIVIQ (see the section “Do not take QUVIVIQ”). Your doctor will advise you.
• Some medications that act on the brain (e.g., diazepam, alprazolam) may interact with QUVIVIQ. Your doctor will advise you.
• Certain medications for blood clotting disorders, such as dabigatran, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.
• Certain medications for heart failure, such as digoxin, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.

QUVIVIQ with food, drinks, and alcohol

Taking alcohol with QUVIVIQ may increase the risk of balance and coordination disturbances.

Avoid taking grapefruit or grapefruit juice at night, as it may increase the amount of QUVIVIQ in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medication.

The effects of QUVIVIQ on the fetus are unknown.

A small amount of QUVIVIQ passes into breast milk. Consult your doctor on the best way to feed the baby during treatment with QUVIVIQ.

The effects of QUVIVIQ on human fertility are unknown.

Driving and operating machinery

It is recommended that there be a period of approximately 9 hours between taking QUVIVIQ and driving or operating machinery. Be careful when driving or using machines in the morning after taking QUVIVIQ. Do not perform potentially hazardous activities if you are not sure you are fully awake, especially shortly after waking up in the first few days of treatment.

QUVIVIQ contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How much QUVIVIQ to take

Your doctor will inform you of the QUVIVIQ dose you should take.

The recommended dose is one 50 mg QUVIVIQ tablet at night.

If you have liver problems, or are taking certain medications, your doctor may prescribe a lower dose, one 25 mg QUVIVIQ tablet at night.

The treatment duration should be as short as possible. After 3 months, your doctor will periodically reevaluate the convenience of continuing treatment.

• Take QUVIVIQ once a night, orally, half an hour before going to bed at night.
• You can take QUVIVIQ with food or without food, however, if you take it with or shortly after a large meal, it may take longer to act.

If you take more QUVIVIQ than you should

If you have taken too much QUVIVIQ, you may experience excessive sleepiness and muscle weakness. Contact your doctor immediately.

If you forget to take QUVIVIQ

If you forget to take QUVIVIQ at bedtime, do not take it later in the night, as you may feel drowsy the next morning. Do not take a double dose to compensate for the missed tablets.

If you interrupt treatment with QUVIVIQ

QUVIVIQ treatment can be interrupted without the need to gradually reduce the dose, and without harmful effects.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them. The following adverse effects may occur with this medication:

Frequent(may affect up to 1 in 10 people):

• Headache
• Excessive drowsiness
• Dizziness
• Fatigue
• Unpleasant sensation (nausea)

Infrequent(may affect up to 1 in 100 people):

• Temporary inability to move or speak (sleep paralysis) lasting several minutes when falling asleep or waking up (see section 2).
• Seeing or hearing vivid or disturbing things that are not real (hallucinations; see section 2).
• Allergic reactions (including skin rash, urticaria)
• Abnormal dreams, nightmares
• Somnambulism

If you experience any of these adverse effects, inform your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after «CAD».

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of QUVIVIQ

The active ingredient is daridorexant.

QUVIVIQ 25 mg film-coated tablets

Each tablet contains daridorexant hydrochloride, equivalent to 25 mg of daridorexant.

QUVIVIQ 50 mg film-coated tablets

Each tablet contains daridorexant hydrochloride, equivalent to 50 mg of daridorexant.

The other components are:

Tablet core: mannitol (E421), microcrystalline cellulose (E460), povidone, sodium croscarmellose (see section 2 "QUVIVIQ contains sodium"), silicon dioxide, magnesium stearate

Protective coating: hypromellose (E464), microcrystalline cellulose (E460), glycerol, talc (E553), titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172; only for 50 mg tablets).

Appearance of the product and content of the container

Film-coated tablet (tablet)

QUVIVIQ 25 mg film-coated tablets

Clear violet-colored triangular tablet, with "25" engraved on one side and "i" (Idorsia logo) on the other.

QUVIVIQ 50 mg film-coated tablets

Clear orange-colored triangular tablet, with "50" engraved on one side and "i" (Idorsia logo) on the other.

QUVIVIQ is available in blister packs containing 10, 20, or 30 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Responsible for manufacturing

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

PharmaKorell GmbH

Georges-Koehler-Str. 2

79539 Lörrach

Germany

Last review date of this leaflet 06/2023

Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.