Chronic insomnia is characterized by difficulty falling asleep or staying asleep, which lasts for at least three months, and is estimated to affect between 6 and 12% of the European population. This sleep disorder has negative effects on the physical and mental health of patients, since they feel sleepy and tired during the day, they find it harder to carry out daily activities or make decisions, and they are even more prone to making mistakes or suffering. an accident.
Now, the European Commission has authorized the marketing of a new drug specifically designed to combat chronic insomnia. This is Quviviq® (Daridorexant), the first dual orexin receptor antagonist (DORA) approved in the European Union for the treatment of chronic insomnia, as announced by the company Idorsia, which has developed it.
How Daridorexant works to treat insomnia
Daridorexant works differently from other insomnia medications in that, instead of inducing sleep by broadly inhibiting brain activity, it only blocks the activation of orexin receptors, thereby decreasing the trigger for insomnia. wakefulness and allows the patient to fall asleep, keeping the structure of all sleep phases intact.
The recommended dose of this medicine is one 50 mg tablet per night, taken orally 30 minutes before going to bed. This dose may be reduced in certain cases, such as in patients with moderate hepatic impairment or those taking moderate CYP3A4 inhibitors, where 25 mg per night is recommended.
Dr. Diego García-Borreguero, a specialist in Neurology and Psychiatry, international medical director of the Sleep Research Institute and one of the Spanish researchers who has participated in the trial program with this molecule, stated that “Daridorexant marks a before and a later in the treatment of chronic insomnia for various reasons. In the first place, because it is the first treatment approved in Europe and that is specifically developed to treat chronic insomnia, a disease that affects a significant part of the population and that, until now, lacked adequate treatment. Secondly, Daridorexant, in addition to improving sleep parameters, keeps the person’s functional capacity intact the next day, reducing the impact of insomnia on quality of life.”
“Daridorexant, in addition to improving sleep parameters, keeps the functional capacity of the person intact the next day, reducing the impact of insomnia on quality of life”
But in addition, continues the expert, “this drug has a radically new mechanism of action that has proven not to generate dependency or tolerance in clinical trials, in which the drug was administered for 12 months, which makes it possible to adjust the timing of the treatment more appropriately and safely for the patient. This aspect is truly revolutionary, since the drugs we currently have were developed for treatments of no more than four weeks due to their safety profile, which did not allow them to adequately treat cases of chronic insomnia”.
Dr. Milagros Merino, a specialist in Clinical Neurophysiology and president of the Spanish Sleep Society, explained that “insomnia has consequences on mental health, physical health and our performance during the day. When you sleep poorly, there is a lower tolerance for frustration and negative conditions. For example, at work, you give up less, make more mistakes, and make decisions based on impulse. Until now, the treatments commonly used were not based on the pathophysiology of insomnia. I believe that Daridorexant is an important step forward because it allows us to directly affect orexin, a neurotransmitter that maintains wakefulness, so that sleep occurs physiologically”.
Quviviq (Daridorexant) does not cause daytime drowsiness
The European Medicines Agency (EMA) has made the decision to approve this drug – which was already approved in January by the FDA – based on the positive results of the phase III trials of Daridorexant that have recently been published in The Lancet Neurology and who demonstrated that, at the recommended dose, this drug improves sleep onset, maintenance, and self-reported subjective total sleep time in adult patients with chronic insomnia.
One of the main objectives of these studies was to analyze the effect of Daridorexant on the patients’ daytime functioning, and for this the participants answered a questionnaire about the symptoms of insomnia and its impact on daytime activity (IDSIQ™ for its acronym in English). English), a tool validated according to the guidelines of the American Food and Drug Administration (FDA) and developed specifically to quantify the results reported by people with chronic insomnia and assess how it affects them in their daily activities during the day.
Daridorexant 50 mg has shown both its safety and a statistically significant improvement in the domain of the IDSIQ questionnaire in reference to excessive daytime sleepiness, which means that patients validated feeling less physically and mentally tired, less sleepy and with more energy during the day. day at months one and three after starting treatment compared to placebo.
The most frequently reported adverse effects of Quviviq® by patients participating in clinical trials were headache and drowsiness (2-3%), although in most cases they were mild or moderate in intensity and no relationship was established between frequency or severity of adverse reactions and dosage. Furthermore, the safety profile in elderly patients was similar to that in younger patients.
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