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Quviviq (Daridorexant)

Quviviq (daridorexant) tablets are an effective treatment for insomnia in adults who have difficulty falling asleep, staying asleep, or both, particularly when insomnia is affecting daytime functioning, following a clinical assessment.

Quviviq works by blocking the action of orexin, a chemical messenger in the brain that promotes wakefulness. By reducing orexin activity, daridorexant helps to decrease wakefulness, making it easier to fall asleep and stay asleep. It belongs to a group of medicines known as orexin receptor antagonists.

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What is Daridorexant used for?

Daridorexant is used to treat insomnia in adults. It is intended for people who have difficulty falling asleep, staying asleep, or both, and whose insomnia is affecting their daily life.

Daridorexant belongs to a class of medicines called orexin receptor antagonists. It works by reducing the activity of orexin, a naturally occurring substance in the brain that helps promote wakefulness. By blocking the action of orexin, daridorexant helps you fall asleep more easily, stay asleep for longer, and may improve your ability to function normally during the day.

How Daridorexant works

Daridorexant works by blocking orexin receptors in the brain. Orexin is a chemical messenger that helps regulate the sleep-wake cycle and keeps you awake.

By reducing the effects of orexin, daridorexant helps to:

  • Make it easier to fall asleep
  • Help you stay asleep for longer
  • Reduce waking during the night
  • Support a more consistent sleep pattern
  • Improve daytime functioning by helping to promote better-quality sleep

These effects can help improve sleep in adults with insomnia when the medication is taken as prescribed.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

The recommended dose for adults:

The recommended dose is one 50mg tablet per night. Take one time per night, by mouth, in the half hour before going to bed at night. You can take this medication with or without food, however it may take longer to work if you take it with or right after a large meal.

If you have liver problems or take certain other medicines, your dose may need to be adjusted.

The treatment duration should be as short as possible. The appropriateness of continued treatment will be assessed within 3 months by your clinician.

Keep a sleep diary

Keeping a sleep diary can help you understand your sleep pattern and identify anything that may be affecting your sleep. Try recording things such as:

  • What time you go to bed and take Quviviq
  • Approximately how long it takes you to fall asleep
  • How often you wake during the night
  • What time you wake up and get out of bed
  • Any daytime naps
  • Your caffeine or alcohol intake
  • How you feel the following day

Keeping this information for a few weeks can help you and your healthcare professional identify patterns, monitor how your sleep is changing and discuss any ongoing difficulties.

If you take more than you should

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

If you forget to take your medication

If you forget to take it 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.

If you stop taking the medication

Treatment with daridorexant can be stopped without a need to gradually reduce the dose, and without harmful effects. However, never stop medication unless your prescribier has been infromed

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Side Effects

Common

  • Headache
  • Excessive sleepiness
  • Dizziness
  • Tiredness
  • Feeling sick (nausea)

Uncommon

  • Temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up
  • Seeing or hearing vivid or disturbing things that are not real (hallucinations)
  • Allergic reactions (including rash, urticaria)
  • Abnormal dreams, nightmares
  • Sleepwalking

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 at 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.

Warning & Precautions

Do not take QUVIVIQ:

  • if you are allergic to daridorexant or any of the other ingredients of this medicine
  • 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.

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.

Age Restrictions

For eligible patients aged 18 to 75 years where treatment is considered clinically appropriate.

Other medicines and Conditions

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. 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.
  • Certain medicines to treat cardiac impairment such as digoxin could interact with QUVIVIQ, which would require some precaution.

Food, drink and alcohol

Drinking alcohol with QUVIVIQ can increase the risk of impaired bal ance and coordination. Avoid grapefruit or grapefruit juice in the evening as they may increase the level of QUVIVIQ in the blood.

Pregnancy and Breastfeeding

This medicine is not suitable for use in pregnancy and breastfeeding.

Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.15359.pdf

Ingredients

  • Active Ingredients: Daridorexant
  • Other Ingredients: Tablet cores: Mannitol (E421), microcrystalline cellulose (E460), povidone, croscarmellose, 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).

Product Information

  • Brand Name: QUVIVIQ
  • Route of Administration: Oral
  • Legal Classification: Prescription Only Medication (POM)
  • Strength: 25mg & 50mg
  • Dosage Form: Tablet

Storage

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and blister foil after EXP. The expiry date refers to the last day of that month.
  • Store in the original package in order to protect from light and moisture. This medication does not require any special temperature storage condition.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Advice & Helpful Links

Sleep tips when taking Quviviq

Take Quviviq as part of your bedtime routine
Quviviq should be taken once a night, around 30 minutes before you go to bed. To help you remember, link taking your tablet to an activity you already do each evening, such as:

  • Turning off the TV
  • Preparing a caffeine-free bedtime drink
  • Getting changed for bed
  • Brushing your teeth
  • Setting your alarm

You could also set a daily reminder on your phone.

Create a relaxing bedtime routine
Give yourself some time to wind down before bed. Try reading, listening to calming music, having a warm bath or shower, or practising relaxation techniques.

Keep your sleep environment comfortable
A bedroom that is dark, quiet and comfortably cool can help promote better sleep. Make sure your bed and pillows are comfortable and try to keep your bedroom primarily for sleep.

Keep regular sleep and wake times
Going to bed and getting up at around the same time each day can help establish a consistent sleep routine. Try to go to bed when you feel sleepy rather than simply because it is a particular time.

Be mindful of caffeine and alcohol
Avoid caffeine  containing drinks such as coffee, tea, cola and energy drinks later in the day, as caffeine can interfere with sleep. Avoid using alcohol to help you sleep, as it can disrupt sleep quality.

Limit screens before bed
Phones, tablets, computers and TVs can be stimulating before bedtime. Try switching off electronic devices and reducing screen time during your wind-down period.

Stay active during the day
Regular physical activity can help improve sleep. However, try to avoid vigorous exercise close to bedtime if you find that it makes it harder to settle.

If you can’t sleep
If you are awake and becoming frustrated, get out of bed and do something quiet and relaxing in low light. Return to bed when you feel sleepy again. Try not to keep checking the clock.

Give your mind time to switch off
If you find yourself worrying at bedtime, writing down your thoughts or a short list of things to deal with the following day can help clear your mind before sleep.

Allow enough time for sleep
Make sure you have enough time available for a full night’s sleep after taking Quviviq. Do not drive or operate machinery if you feel sleepy or are not fully alert the following day.

Remember: Good sleep habits work alongside your treatment. If your sleep problems continue or get worse despite treatment, speak to your doctor or pharmacist.

https://www.nhs.uk/conditions/insomnia/

https://www.nhs.uk/every-mind-matters/mental-health-issues/sleep/

https://www.nhs.uk/every-mind-matters/mental-wellbeing-tips/how-to-fall-asleep-faster-and-sleep-better/

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