What is Quviviq, a new insomnia treatment approved by the European Medicines Agency?

Instead of putting the brain to sleep to prevent insomnia, this treatment will work on waking up, “which will help people fall asleep faster” and “stay asleep longer,” the EMA notes.

A new remedy for sleep disorders? The European Medicines Agency (EMA) began marketing a new insomnia medicine called Quviviq in May. It is developed by Idorsia, a Swiss biotech run by a French couple, and was already allowed in the United States last January. It will not be available for prescription.

This treatment “achieves 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 sleep deprivation.” , Jean-Paul Clozel, the French CEO of Idorsia, told Le Figaro.

· What else will this drug bring?

To combat insomnia, the best known treatment is sleeping pills, which have a numbing effect on the brain. The Quviviq will act on waking up thanks to its active substance which is the daridorexant. Merck Lab already had it placed on the Japanese, American, Australian and Canadian markets its supervixing agent, based on the same principle as daridorexant.

“It works by blocking the action of orexin, a substance produced by the brain that promotes arousal,” the EMA wrote. “This means that Quviviq helps people fall asleep faster, stay asleep longer, and improve their functioning during the day.”

Quviviq results were demonstrated in two main studies, not significant in 930 patients, published in The Lancet.

“Those who received 50 mg of Quviviq for three months saw a 29-minute reduction in the amount of time they spend waking up each night, compared with an 11-minute reduction for those who received a placebo,” he said. EMA. “In addition, after three months of treatment, patients taking 50 mg of Quviviq fell asleep about 35 minutes faster than before treatment, while those on placebo fell asleep 23 minutes faster.”

· How is it used?

“Unlike other sleeping pills that tend to put you to sleep by increasing sleep, this one tries to put you to sleep by decreasing your awakening,” said BFMTV’s Marc Rey, a neurologist and president of the National Institute of Sleep and Vigilance. “We have a new weapon, so that’s interesting, but it’s important to understand that this new weapon must first target patients who have been diagnosed by the doctor who cares for them.”

This drug should be used “to treat adults with insomnia (difficulty sleeping) that has lasted for at least three months and that has a significant impact on their functioning during the day,” the EMA said. it is “only issued by prescription”.

Available as pills, the recommended dose of Quviviq is one 50 mg tablet in the evening – or 25 mg if the doctor thinks a lower dose is more appropriate – “no more than 30 minutes at bedtime” , explains the European agency. In addition, this treatment “should be as short as possible and re-evaluated by your doctor within three months.”

· Some side effects?

“The most common side effects are headache and drowsiness,” he said. The FDA points out the risks of aggravation of depression and suicidal thoughts, sleep paralysis, somnambulism or decreased consciousness and alertness: and to think clearly can be diminished. “

Several “most side effects are mild to moderate in intensity,” the EMA points out, recalling that “as with all medicines, data on the use of Quviviq are constantly monitored. Adverse reactions reported with Quviviq are carefully evaluated and all necessary measures are taken to protect patients. “

According to a 2017 French Public Health barometer, in France, chronic insomnia affects 13.1% of 18-75 year olds, 16.9% of women and 9.1% of men.

Salome Vincendon BFMTV journalist

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