Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality

Inclusion Criteria

• •Patients of legal age with DSM-5(\*) diagnostic criteria for insomnia assessed from the Sleep Test responses (ST: 5-item questionnaire modified from the "Oviedo Sleep Questionnaire").
• •Patients with insomnia of the following types: sleep onset insomnia (\> 30 minutes of sleep latency), maintenance insomnia (frequent awakenings or inability to fall asleep after awakening) or mixed insomnia
• •Patients who are not on treatment or have not taken any dietary supplements or hypnotics for insomnia, or any other psychoactive drug in the past week.
• •Patients able to understand the implications of the study and who demonstrate this by voluntarily signing the informed consent
• •DSM-5 diagnostic criterion for insomnia:
• •A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
• •1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
• •2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)
• •3. Early-morning awakening with inability to return to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
• •C. The sleep difficulty occurs at least 3 nights per week. D. The sleep difficulty is present for at least 3 months. E. The sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
• •G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
• •H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.