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Quviviq, a drug with a new mode of action, authorized in Europe

After its marketing authorization in the United States in January, it is Europe’s turn to say yes to the marketing of Quviviq, from the Swiss biotech company Idorsia, against insomnia. On February 24, a few days before the European Commission, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended the approval of thirteen medicines, among them Quviviq, a medicine intended for the treatment of adults suffering from insomnia for at least 3 months and with a considerable impact on their functioning during the day. This prescription-only medication is available in tablet form, with a recommended 50mg in the evening (or 25mg if the doctor considers a lower dose appropriate) no later than 30 minutes before bedtime . Treatment should be as short as possible and reassessed by a doctor within 3 months. The latter is intended as an alternative to conventional sleeping pills, with the particularity of acting on the awakening capacities of the brain rather than putting it to sleep to prevent insomnia.

Specifically, the active substance in Quviviq, daridorexant, is a dual orexin receptor antagonist (DORA). It works by blocking the action of orexin, a substance produced by the brain that promotes wakefulness by attaching to two types of receptors (targets) for orexin. The goal: to reduce nocturnal hyperarousal to improve sleep without residual effects the next morning in insomniac patients and thus improve daytime functioning. ” It is a real revolution. “, explains to the newspaper Le Figaro Jean-Paul Clozel, the French CEO of Idorsia. “ The Quviviq allows natural sleep at night while preserving the patient’s quality of life during the day. This is an important breakthrough for anyone who is afraid to go to bed because they fear sleeping poorly. In a statement, the company recalls that chronic insomnia disorder is one of the most common sleep disorders in Europe, affecting between 6% and 12% of the adult population.

Significantly faster time to fall asleep

Thus, insomnia is defined as difficulty in initiating or maintaining sleep, causing distress or impairment in important areas of daytime functioning. This impact on the quantity or quality of sleep must be present at least three nights a week and last for at least three months. The EMA’s approval is based in particular on the results of a study involving 930 patients published in The Lancet : those who received 50mg of Quviviq for 3 months were able to reduce the time spent awake each night by an average of 29 minutes, compared with 11 minutes for those who received placebo (a dummy treatment). In addition, after three months of treatment, patients who took 50 mg of Quviviq fell asleep about 35 minutes faster than before treatment, compared to 23 minutes for those who took the placebo. The most reported adverse reactions were headache and somnolence, reported in 3% and 2% of patients treated with 25 mg and 50 mg doses, respectively.

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The European Medicines Agency explains that ” two main studies have shown that Quviviq is effective in increasing how long patients with insomnia sleep and improving their functioning during the day. Side effects are considered manageable. Its benefits outweigh its risks and it may be authorized for use in the EU. Note that the drug in the form of a 25 mg tablet will be available for patients taking certain concomitant medications. In addition, the latter should not be used in people who are hypersensitive (allergic) to any of the ingredients, in people with narcolepsy or in people who use potent CYP3A4 inhibitors (a group of drugs). Its concomitant use in cases of hepatitis, alcohol consumption, pregnancy and breastfeeding is also not recommended and a period of 9 hours is recommended for driving or using machines.

Sleeping pills for insomnia: caution

By way of conclusion, the EMA recalls that “ As with all medicines, data on the use of Quviviq is continuously monitored. Suspected adverse events are carefully assessed and all necessary measures are taken to protect patients, so it is important to report any suspected adverse events. “. It took the company more than 20 years of research and thousands of compounds tested to achieve such a result, the challenge being to find a treatment that respects the delicate balance between nocturnal rest and daytime functioning. After the United States, with the arrival of the first boxes in pharmacies from this month of May, and Europe (as well as in the countries of the European Economic Area), discussions have also begun with the systems healthcare in Switzerland and Canada. If this drug acts as a novelty in France, the Merck laboratory has already marketed its Belsomra treatment (suvorexant active ingredient) in several countries since 2014, based on the same mechanism of action.

In France, Health Insurance considers that the treatment of insomnia must be based primarily on sleep hygiene (diet, regular bedtime and waking times, etc.), on the treatment of possible causes (environment unfavorable to sleep , depression or anxiety disorders, diseases causing pain, hyperthyroidism, obstructive sleep apnea syndrome, etc.), then on herbal medicine (based on valerian, hawthorn, passionflower, etc.) or a light sedative (melatonin) and finally on sleeping pills after consultation with a doctor. On the subject, the organization indicates that a “ Hypnotic treatment should be of short duration (less than four weeks) and should always be started at the lowest possible dose. Its effectiveness should be reassessed and this treatment should be stopped as soon as possible to avoid addiction. Similarly, it is important to respect all the precautions that go with the use of these drugs, and in particular the restrictions associated with driving vehicles.

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