QUVIVIQ 25 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What QUVIVIQ is and what it is used for
2. What you need to know before you take QUVIVIQ
3. How to take QUVIVIQ
4. Possible side effects
5. How to store QUVIVIQ
6. Contents of the pack and other information

Orexin is a substance produced by the brain that helps keep you awake. By blocking the action of orexin, QUVIVIQ enables you to fall asleep faster and stay asleep longer, and improves your ability to function normally during the day.

• if you are allergic to daridorexant or any of the other ingredients of this medicine (listed in section 6).
• if you have narcolepsy, a condition that causes you to suddenly and unexpectedly fall asleep at any time.
• if you are taking medicines which may increase the level of QUVIVIQ in your blood such as:
  • oral medicines to treat fungal infections such as ketoconazole, posaconazole, voriconazole, itraconazole.
  • certain medicines to treat bacterial infections such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin.
  • certain medicines to treat HIV infection such as ritonavir, elvetegravir, indinavir, saquivanir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir.
  • certain medicines to treat cancer such as ceritinib, idelasilib, ribociclib, tucatinib.

Ask your doctor if the medicine you are taking prevents you from taking QUVIVIQ.

Talk to your doctor or pharmacist before taking QUVIVIQ if you:

• have depression or have or ever had suicidal thoughts
• have a psychiatric disorder
• currently take medicinal products that affect your brain such as treatments for anxiety or depression
• have regularly taken drugs (except as medicines) or been addicted to drugs or alcohol
• have liver problems: depending on their severity, QUVIVIQ may not be recommended, or a lower dose might be required.
• have breathing difficulties (such as severe chronic obstructive pulmonary disease)
• have a history of falling and are older than 65 (because there is generally a higher risk of falling in patients > 65).

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

Tell your doctor if you get any of the following side effects while taking QUVIVIQ:

• sleep paralysis: a temporary inability to move or talk for up to several minutes upon awakening or falling asleep
• hallucinations: seeing or hearing vivid or disturbing things that are not real upon awakening or falling asleep

If you have depression and you experience a worsening or have thoughts of harming yourself, call your doctor straight away.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines because:

• certain antibiotics (erythromycin, ciprofloxacin, clarithromycin, rifampicin), immuno-suppressants (cyclosporine), antifungal agents (itraconazole), cancer treatments (ceritinib), or HIV treatments (ritonavir, efavirenz) can increase or decrease the level of QUVIVIQ in the blood. Some of these medicines may be contra-indicated with QUVIVIQ (see section “Do not take QUVIVIQ”). Your doctor will advise you on this.
• certain medicines that work in your brain (e.g., diazepam, alprazolam) could interact with QUVIVIQ. Your doctor will advise you on this.
• certain medicines to treat blood coagulation disorder such as dabigatran could interact with QUVIVIQ, which would require some precaution. Your doctor will advise you on this.
• certain medicines to treat cardiac impairment such as digoxin could interact with QUVIVIQ, which would require some precaution. Your doctor will advise you on this.

Drinking alcohol with QUVIVIQ can increase the risk of impaired balance and coordination.

Avoid grapefruit or grapefruit juice in the evening as they may increase the level of QUVIVIQ in the blood.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

It is not known if QUVIVIQ can harm your unborn baby.

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

It is not known if QUVIVIQ affects human fertility.

A period of approximately 9 hours is recommended between taking QUVIVIQ and driving or using machines. Be cautious about driving or using machines in the morning after taking QUVIVIQ. Do not engage in potentially hazardous activities if you are not sure you are fully alert, especially in the first few days of treatment.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Your doctor will advise you on the dose of QUVIVIQ to take.

The recommended dose is one 50-mg tablet of QUVIVIQ per night.

If you have liver problems or take certain other medicines, your doctor may prescribe you a lower dose of one 25-mg tablet of QUVIVIQ per night.

The treatment duration should be as short as possible. The appropriateness of continued treatment will be assessed within 3 months by your doctor and periodically thereafter.

• Take QUVIVIQ, one time per night, by mouth, in the half hour before going to bed at night.
• You can take QUVIVIQ with or without food, however it may take longer to work if you take it with or right after a large meal.

If you take more QUVIVIQ than you should, you may experience excessive sleepiness and muscle weakness. Contact your doctor straight away.

If you forget to take QUVIVIQ at bedtime, then you should not take it later during the night, otherwise you may feel drowsy in the morning. Do not take a double dose to make up for a forgotten tablet.

Treatment with QUVIVIQ can be stopped without a need to gradually reduce the dose, and without harmful effects.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance 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 ingredients are:

Tablet cores: Mannitol (E421), microcrystalline cellulose (E460), povidone, croscarmellose sodium (see section 2 “QUVIVIQ contains sodium”), silicon dioxide, magnesium stearate.

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

Film-coated tablet (tablet)

QUVIVIQ 25 mg film-coated tablets

Light purple, triangular tablet with 25 on one side, and ‘i’ (Idorsia logo) on the other side.

QUVIVIQ 50 mg film-coated tablets

Light orange, triangular tablet with 50 on one side, and ‘i’ (Idorsia logo) on the other side.

QUVIVIQ is available in blister packs of 10 or 30 film-coated tablets.

Not all pack sizes may be marketed.