[Niaprazine in adult and elderly sleep disorders: results of an observational study on perceived efficacy and tolerability.]

Abstract

Aim: The aim of the study was to define compliance and clinical efficacy on sleep disorders of a niaprazine-based galenic product; the active molecule marketed by an Italian pharmaceutical company since long time is no longer available as medical prescriptions are mostly oriented towards benzodiazepines and derivatives whose side effects in the medium-long term suggest however moderating and modulating their use. Niaprazine might therefore be prescribed in the interval drop out of benzodiazepines, or even as a primary therapeutic indication without significant side effects as widely confirmed by its previous historical use very frequent in children. Our research evaluated some aspects of prescribing pertinence and the clinical outcome results obtained with the use of galenic niaprazine in a cohort of patients with an indication for hypnoinducing treatment.

Methods: In our observational and retrospective anecdotal study, we recruited, through the Second Opinion Network, 42 otherwise healthy volunteer subjects aged between 30 and 83 years, most of whom were engaged in a nighttime evening use of mobile phones, tablets and computers who complained of difficulty falling asleep and early morning awakenings partly due to physiological reasons (micturition stimuli, thirst, sweating or other). Each patient was instructed to take niaprazine 50 mg/ml produced in galenic formula by the Farmacia del Pavaglione in Bologna and supplied by the ACEF Spa company in Fiorenzuola d'Arda (Piacenza, Italy). Specifically, each patient took 8 drops before bedtime for a treatment period of 30 days. Each patient was then subjected to the following questionnaires at the beginning of the study and at the end of the treatment: 1) Sleep Disturbance Questionnaire (QDS). 2) Pittsburgh Sleep Quality Index (PSQI). 3) Insomnia Severity Index (ISI).

Results: The data collected from the evaluation of the questionnaires (QDS, PSQI, and ISI) performed before and after the treatment showed that the quality of sleep and in general the quality of life of each patient was significantly increased (p<0.0001****).

Conclusions: The results of our study confirm what is already known about the safety and handling of niaprazine formulated galenically in sleep disorders; in all cases its efficacy (only one drop out) was appreciated with a request to prolong its treatment, especially in subjects dedicated, in the evening hours, to cortical hyperarousal from prolonged (sometimes exhausting) use of technological means, low physical activity (and consequent poor cerebral oxygenation), and in those who had already benefited from the use of an industrial syrup based on niaprazine (Nopron) currently suppressed.