Instead of putting the brain to sleep to prevent insomnia, this treatment will act on waking, “which will help people fall asleep faster” and “stay asleep longer”, notes the EMA.
A new cure for sleep disorders? The European Medicines Agency (EMA) gave its authorization at the beginning of May for the marketing of a new drug against insomnia called Quviviq. It is developed by Idorsia, a Swiss biotech run by a French couple, and was already authorized in the United States last January. It will only be available on prescription.
This treatment “makes it possible to obtain a natural sleep during the night while preserving the patient’s quality of life during the day. It is an important advance for all those who are afraid to go to bed because they fear sleeping poorly” , explains to Le Figaro Jean-Paul Clozel, the French CEO of Idorsia.
· What more will this medicine bring?
To fight against insomnia, the best-known treatment is that of sleeping pills, which have a drowsiness effect on the brain. The Quviviq will act on waking up thanks to its active substance which is daridorexant. Merck laboratory had already marketed its suvorexant, based on the same principle as daridorexant, on the Japanese, American, Australian and Canadian markets.
“It works by blocking the action of orexin, a substance produced by the brain that promotes wakefulness,” writes the EMA. “This means Quviviq helps people fall asleep faster, stay asleep longer, and improve their functioning throughout the day.”
The results of Quviviq have been demonstrated in two main studies, including one involving 930 patients, published in The Lancet.
“Those given 50mg of Quviviq for three months saw an average reduction of 29 minutes in the time they were awake each night, compared to an 11-minute reduction for those given a placebo,” says the EMA. . “Additionally, after three months of treatment, patients who took 50 mg of Quviviq fell asleep approximately 35 minutes faster than before treatment, while those on placebo fell asleep 23 minutes faster.”
· How is it used?
“Unlike other sleeping pills which tend to make you sleep by increasing sleep, this one tries to make you sleep by decreasing your alarm clock”, summarizes with BFMTV Marc Rey, neurologist and president of the national institute of sleep and alertness. “We have a new weapon, so that is interesting, but it must be made clear that this new weapon must first be addressed to patients who have been diagnosed by the doctor who takes care of them.
This drug should be used “to treat adults suffering from insomnia (difficulty sleeping) which has lasted at least three months and which has a considerable impact on their functioning during the day”, specifies the EMA, stressing that ‘is only available on prescription’.
Available in pill form, the recommended dose of Quviviq is one 50mg tablet in the evening – or 25mg if the doctor feels a lower dose is more appropriate – “no more than 30 minutes after bedtime” , explains the European agency. In addition, this treatment “must be as brief as possible and reassessed by your doctor within three months”.
· What are the side effects?
“The most common side effects are headache and drowsiness,” it says on the drug’s website, but others have been listed. The FDA thus underlines the risks of aggravation of depression and suicidal thoughts, sleep paralysis, sleepwalking or even reduced consciousness and alertness: “The morning after taking Quviviq, your ability to drive safely and to think clearly can be diminished.”
But “most side effects are mild to moderate in intensity”, emphasizes the EMA, which recalls that “as with all medicines, data on the use of Quviviq are continuously monitored. Side effects reported with Quviviq are carefully assessed and all necessary measures are taken to protect patients.”
According to a 2017 Public Health France barometer, in France, chronic insomnia affects 13.1% of 18-75 year olds, 16.9% of women and 9.1% of men.