Before we dive into this article and learn more about daridorexant, we need to note that daridorexant and Quviviq are the same drug. During this article we may use these two names interchangeably.
Previously, daridorexant was available only via private prescriptions in the UK. However, daridorexant will now be available as a prescription medicine on the NHS. This is excellent news, as everyone suffering from chronic insomnia can now access a pharmacological treatment that is licenced for use over the long term.
Our aim with this article has been to succinctly describe what daridorexant is, and provide an evidence-based overview, allowing you to make informed decisions regarding your health should you wish to consider this medication.
What is Daridorexant (Quviviq)?
Daridorexant is a dual orexin receptor antagonist (DORA) – if this sounds complicated don’t worry, we will explain this is in more detail later! Daridorexant is also known by its brand name, ‘Quviviq’ and has been developed by a pharmaceutical company named Idorsia, which is based in Switzerland.
This medication has undergone multiple clinical trials and other studies to ensure its efficacy in treatment. The drug has been approved in many countries primarily the USA, UK, and Canada.
What is Daridorexant used for?
Daridoderant is used for the treatment of chronic insomnia. This is a condition where you may find it difficult to fall asleep, stay asleep, wake up earlier than desired and have an overall reduced total sleep time. Insomnia is known to affect up to 1 in 3 people in the UK – particularly those who are elderly. Insomnia is associated with a number of physical and mental health issues, and untreated, or sub-optimally treated chronic insomnia can have a profoundly negative impact on the quality of people’s lives.
Chronic insomnia is defined as poor sleep quantity or quality which significantly and negatively impacts daytime functioning. It involves difficulty initiating and/or maintaining sleep at least three times a week for at least three months.
Chronic insomnia disorder is insomnia that persists beyond three consecutive months, and it can take its toll on a person’s physical and mental health. Research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.
How does Daridorexant work?
Insomnia treatment goals are to improve sleep quality and quantity and daytime functioning while avoiding next-morning residual effects. Current recommended treatments for insomnia include:
- Implementing good sleep hygiene
- Cognitive behavioural therapy for insomnia (CBTi)
- Pharmacotherapy
Daridorexant is a new product in a class of drugs called dual orexin receptor antagonists (DORA). This drug works on the orexin system, which promotes wakefulness. It must be noted that wake and sleep signalling are regulated by intricate neural circuitry in the brain. Orexin neuropeptides promote wakefulness through orexin receptors OX1R and OX2R. Together, the neuropeptides and the receptors make up the orexin system.
The orexin system then stimulates the release of other chemicals which promote wakefulness. In individuals with no insomnia, orexin levels rise through the day as wakefulness is promoted and then fall at night. However, according to research, in chronic insomnia disorder, these wake-promoting brain regions remain overactive at night. Thus, orexin provides a specific target for pharmacological intervention in the treatment of insomnia.
DORAs work by selectively blocking the activity of orexin, meaning they turn down overactive wakefulness. This approach is very different to the current pharmacological approach, which focuses on central nervous system sedation. Blocking the orexin receptors reduces the downstream activity of the overactive chemicals in insomnia. This antagonism or ‘blocking’ of orexin receptors thus targets a fundamental mechanism of insomnia and is the principle on which daridorexant works.
Some fascinating history: Idorsia’s research team has been working on the science of orexin and orexin receptors since 1998.
Regarding daridorexant, Idorsia commenced the main placebo-controlled study to investigate the effects of three different daridorexant doses. This study found that daridorexant 25mg and 50mg improved sleep outcomes in those with insomnia. Daridorexant 50mg also improved daytime functioning in those with insomnia. Both doses were deemed to be safe for use.
When will Daridorexant become available on the NHS?
Daridorexant has received approval from the governing body of rules and regulations for treatments in the UK, The National Institute for Health and Care Excellent (NICE). The treatment is due to be rolled out across all NHS Trusts, so that NHS patients with chronic insomnia can access this new treatment. We recommend contacting your local GP or sleep specialist for more accurate information, as there may be variability in the availability of the drug to begin with.
When should I take Daridorexant?
Before taking daridorexant, you would need to see a sleep specialist, GP or a doctor experienced in the treatment of chronic insomnia for a review of your symptoms and to confirm the duration of your insomnia. In the first instance, NICE recommends the use of cognitive behavioural therapy for insomnia (CBTi) as the first line intervention to tackle chronic insomnia.
However, NICE and the NHS have acknowledged access to CBTi can vary. Thus, daridorexant has been recommended as a suitable alternative where CBTi is unavailable, or has been tried and was unsuccessful.
In terms of dosages, both the 25mg and 50mg are available to be prescribed on the NHS. Please read below for NICE’s recommended treatment plans:
- The recommended dose for adults is one 50 mg tablet once per night, taken orally in the evening within 30 minutes before going to bed.
- The recommended dose is 25 mg once per night for those patients taking moderate CYP3A4 inhibitors (e.g., erythromycin, ciprofloxacin, cyclosporin).
- The maximum daily dose is 50 mg.
- Missed dose: If a patient forgets to take daridorexant at bedtime, that dose should not be taken during the night.
- The treatment duration should be as short as possible. The appropriateness of continued treatment should be assessed within 3 months, and periodically after that.
- Clinical data is available for up to 12 months of continuous treatment. Treatment can be stopped without down-titration.
Please visit this page for further in-depth information on how NICE has recommended that daridorexant be prescribed. Please contact your local GP or sleep specialist for information that can be more tailored to you. We have detailed the doses above to provide you with all the information available, although this should not be considered as medical advice. It is very important to remember that your personalised treatment plan should be made in conjunction with your own health provider.
Are there any side effects to Daridorexant?
Daridorexant can potentially cause serious side effects if not taken and monitored carefully. It may cause a decreased awareness and alertness the following day, so you must be extremely cautious about driving if you experience any drowsiness or daytime sleepiness. Some people may also experience headaches, dizziness, fatigue and nausea.
To tackle this, please do not:
- Take more daridorexant than prescribed.
- Do not take Quviviq unless you are able to stay in bed for a full night (at least 7 hours before you must be active again).
- Take the drug in the evening more than 30 minutes before you plan to do to bed.
You should not take the drug if:
- You fall asleep often at unexpected times (narcolepsy).
- You have an allergic reaction to daridorexant, or any of the ingredients in Quviviq.
Tell your healthcare provider
Finally, before taking Quviviq, tell your healthcare provider about all of your medical conditions, including if you:
- Have a history of depression, mental illness, or suicidal thoughts or actions
- Have a history of drug or alcohol abuse or addiction
- Have a history of a sudden onset of muscle weakness (cataplexy)
- Have a history of daytime sleepiness
- Have lung or breathing problems, including sleep apnoea
- Have liver problems
- Are pregnant or plan to become pregnant. It is not known if Quviviq can harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who are exposed to Quviviq during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-833-400-9611. Talk with your healthcare provider about the risk to your unborn baby if you take Quviviq during your pregnancy.
- Are breastfeeding or plan to breastfeed. It is not known if Quviviq passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Quviviq.
- Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Taking Quviviq with certain medicines can cause serious side effects.
- Quviviq may affect the way other medicines work and other medicines may affect the way Quviviq works.
- Do not take Quviviq with other medicines that can make you sleepy unless your healthcare provider tells you to.
It is important for your healthcare provider to be aware of all prescription and non-prescription medications you are currently taking.
If considering daridorexant, please consult your healthcare provider and ensure that you do have insomnia and no other sleep disorders such as sleep apnoea, narcolepsy or restless legs syndrome.
Please read this for further information from Idorsia, the manufacturers of daridorexant.
Can I eat and drink normally whilst taking Daridorexant?
Daridorexant should not be taken with food or right after a meal, as the drug will work faster on an empty stomach. However, please follow the advice provided by your healthcare provider, as it will be tailored to you.
Drinking alcohol with Quviviq can increase the risk of impaired balance and coordination. Therefore, alcohol should be avoided during treatment with Quviviq. Avoid consuming grapefruit or grapefruit juice in the evening as they may increase the levels of Quviviq in the blood.
Where can I find more information about daridorexant?
Daridorexant is a very novel drug with the ability to transform the lives of those suffering from insomnia. Please contact your local GP or sleep specialist for the best and most up-to-date information. If you would like to learn more about it in general, please refer to Idorsia or NICE.
As a sleep physician and psychiatrist, we offer consultations for those struggling to sleep due to insomnia or other sleeping disorders. If you have questions about daridorexant / Quviviq, and are struggling with insomnia, please feel free to get in touch to arrange a consultation.
