The European Comission has granted marketing authorization to Daridorexant (trade name QUVIVIQ®) for the treatment of adult patients with chronic.
This is great news for all those patients who suffer problems for more than 3 months both to fall asleep and to maintain it, with what this also implies in the considerable negative impact that it causes in their daytime functionality.
It should not be forgotten that the prevalence of chronic insomnia in Europe is between 6% and 12% of the population.
The Dr. Milagros Merinospecialist in Clinical Neurophysiology and president of the , explains that “insomnia has consequences on mental health, physical health and on our performance during the day. When you sleep poorly, there is a lower tolerance to frustration and negative conditions” .
The specialist gives several examples of the consequences that chronic insomnia produces in the daily life of patients. “For example, at work you give up less, you make more mistakes, and you make decisions based on impulse.”
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“Until now, the treatments commonly used were not based on the pathophysiology of insomnia. I believe that Daridorexant It is an important step forward because it allows us to directly affect orexin, a neurotransmitter that maintains wakefulness, so that sleep occurs physiologically.”
How does the new drug work?
The novelty of this new drug lies in the fact that, instead of inducing sleep through a broad inhibition of brain activity, what it does is exclusively block the activation of orexin receptors, a hormone related to keeping us awake.
In this way, it reduces the trigger for wakefulness and allows sleep to occur, keeping its structure intact in all its phases.
The recommended dose of Daridorexant is one 50 mg tablet per night, taken orally, taken 30 minutes before bedtime.
These doses can be adapted in patients suffering from other types of pathologies such as moderate liver failure.
Advantages of Daridorexant
He Dr. Diego Garcia-Borregueroa specialist in Neurology and Psychiatry, international medical director of the Sleep Research Institute and one of the Spanish researchers in the trial program with this molecule, comments that the new drug “marks a before and after in the treatment of chronic insomnia”.
On the one hand, because it is the first specific treatment for this sleep pathology that “until now, lacked adequate treatment.”
Secondly, emphasizes Dr. García-Borreguero, because it allows the feeling of drowsiness not to remain throughout the day.
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“In addition to improving sleep parameters, it keeps the person’s functional capacity intact the next day, reducing the impact that insomnia has on quality of life.”
In fact, during clinical trials it was observed that patients validated feeling less physically and mentally tired, less sleepy and with more energy during the day in months 1 and 3 after the start of treatment, compared to the group that was taking the placebo.
And the last aspect to take into account is that this drug, unlike others used up to now, does not generate dependence in the patient, so the treatment can be extended over time.
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“This aspect is truly revolutionary, since the drugs that we currently have were developed for treatments of no more than 4 weeks due to their safety profile, which did not allow to adequately treat cases of chronic insomnia.”
On the other hand, “Daridorexant has a radically new mechanism of action that has proven not to cause dependence in clinical trials, in which the drug was administered for 12 months, thus allowing the timing of treatment to be adjusted more adequately and safe for the patient,” says Dr. García-Borreguero.
Mild side effects
In clinical trials, the most frequently reported adverse reactions were headache and somnolence (2-3%). In addition, most of them had a mild or moderate intensity.
This is how the European Medicines Agency describes it
Under the title of ANNEX I. TECHNICAL SHEET OR SUMMARY OF PRODUCT CHARACTERISTICSEma presents a of which for your interest we reproduce here the first pages:
This medicine is subject to additional monitoring, which will speed up the discovery of new information about its safety. Healthcare professionals are asked to report any suspected adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
QUVIVIQ 25 mg film-coated tablets
QUVIVIQ 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
QUVIVIQ 25 mg film-coated tablets
Each film-coated tablet contains daridorexant hydrochloride equivalent to 25 mg daridorexant.
QUVIVIQ 50 mg film-coated tablets
Each film-coated tablet contains daridorexant hydrochloride equivalent to 50 mg daridorexant.
To consult the full list of excipients, .
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
QUVIVIQ 25 mg film-coated tablets
Light purple, triangular arc-shaped film-coated tablet, debossed with “25” on one side and “i” on the other.
QUVIVIQ 50 mg film-coated tablets
Compressed…