Excessive daytime sleepiness, new treatment available in Italy

A new drug is available in Italy, pitolisant (Ozawade *), indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnea (Osa) in whom EDS has been unsatisfactorily treated by primary therapy for sleep apnea, such as continuous positive airway pressure (CPAP) or in which such therapy has not been tolerated, as registration studies show. Excessive daytime sleepiness (Eds) – it was recalled today, during a press meeting promoted by the pharmaceutical company Bioprojet Italia – is one of the symptoms that patients with obstructive sleep apnea syndrome (Osa, Obstructive sleep apnea). This disorder, which is estimated to affect about 7 million Italians, is characterized by pauses in breathing during sleep (apnea) or a significant reduction in the passage of air into the airways due to partial or total obstruction of the upper airways ( hypopnea). During sleep, between apneas and hypopneas, the walls of the upper airways close with variable frequency, decreasing the oxygen saturation of hemoglobin (hypoxemia) which causes micro-awakenings of 10-30 seconds, but also of a minute, not perceived from the patient, but leading to fragmented, less effective and non-restorative sleep. The main symptom that prompts patients to seek medical attention is snoring, but many also complain of excessive sleepiness during the day. This disorder is usually associated with fatigue, attention and concentration difficulties, irritability. These symptoms have a strong impact on the quality of life of patients who suffer from it and often have a reduced productivity at work, they risk falling asleep while driving, in the presence of family and friends, thus compromising social life, also given the lack of desire to go out in the evening. “This new drug acts on receptors found on brain cells that are involved in stimulating alertness. Specifically, the drug works by binding to histamine H3 receptors. This increases the activity of certain brain cells called histaminergic neurons, important for keeping the body awake “, explains Luigi Ferini Strambi, head of the sleep medicine center of the San Raffaele Hospital Irccs and full professor of Neurology at the Vita-Salute San Raffaele University in Milan. ‘innovative action, which enhances the transmission of stimuli along the central histaminergic pathways, pitolisant therefore promotes the wakefulness of patients without having psychostimulating effects and without causing an increase in blood pressure and heart rate, often already altered in the patient with apnea. In addition, the treatment has also been shown to be effective on asthenia, the feeling of excessive fatigue that afflicts patients. “The efficacy of this drug in the treatment of excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea syndrome – continues Ferini Strambi – has been demonstrated in two randomized clinical trials called Harosa I and Harosa II. These evaluated the effects of the drug on sleepiness both in patients treated with CPAP and in those who could not tolerate this treatment. They also showed that its intake had no undesirable effects on systolic or diastolic blood pressure, nor on heart rate, and did not induce addiction. It is essential for us to have an extra weapon capable of counteracting excessive daytime sleepiness and excessive tiredness , which – he concludes – have a very significant impact on the social life and daily activities of patients “.