Daridorexant: this is the new insomnia pill that causes less dependence and side effects
The drug, with a medical prescription, does not usually leave drowsiness the next day, which improves daytime activity
Experts warn: no medicine is the solution for a problem that indicates that there are others
One in ten people do not get to sleep at night on a regular basis. Chronic insomnia erodes the health and well-being of those who suffer from it, so they may need medication to rest. Now, the European Medicines Agency has given the green light to a new pill: daridorexant .
The drug, which is sold under the brand name Quviviq, produces fewer side effects , does not create dependency or tolerance. That is, the body does not get used to it and needs to increase the dose. In addition, it does not usually leave drowsiness the next day, so it improves daytime activity, according to the two main studies carried out, published in The Lancet. Even so, experts warn: no pill is the solution for a problem that indicates that there are others.
“It acts on the neurotransmitter that keeps us awake, orexin , and which is curiously lacking in people suffering from narcolepsy,” Milagros Merino, president of the Spanish Sleep Society, explains to TVE about the drug, which you will need a prescription to buy in pharmacies. Before, the Spanish Agency for Medicines and Health Products will have to authorize it in the country.
Few side effects
Few side effects, but it is recommended not to prolong the treatment
According to the European Union regulator , doctors can prescribe it to treat adults who are suffering from insomnia problems “for at least three months” . It is taken 30 minutes before bedtime, although it may take longer to work if you have eaten heavily.
“The duration of treatment should be as short as possible and your doctor should re-evaluate its continuation after three months,” warns the EMA.
The Quviviq package insert lists headache and drowsiness as the most frequent adverse effects, which can affect 10% of patients and are mostly “mild or moderate”. Therefore, the European agency has decided that its benefits “are greater than its risks.”
The clinical trials have been carried out in the Sleep Unit of the Vall d’Hebron Hospital in Barcelona. From there, the specialist Odile Romero comments on another of its advantages: “although we do not have studies that can prove it, in principle, this drug would not be so contraindicated in patients who may have respiratory problems.”
So far, according to the studies, daridorexant did not increase the frequency of apnea and hypopnea episodes or cause oxygen desaturation in patients with mild or moderate obstructive sleep apnea (OSA) or moderate chronic obstructive pulmonary disease (COPD). It would still be necessary to investigate the effects on those who suffer from these pathologies in a serious way.
However, daridorexant is contraindicated for people allergic to any of its components, patients with narcolepsy or who are being treated with “potent CYP3A4 inhibitor” drugs.
Likewise, it should be used with “caution” for the elderly population and patients with psychiatric disorders -since the efficacy and safety data are still limited- and for people with symptoms of depression. Like other hypnotics, it can cause them to worsen and suicidal ideation.