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 theSleep Test responses (ST: 5-item questionnaire modified from the "Oviedo SleepQuestionnaire").
• Patients with insomnia of the following types: sleep onset insomnia (> 30 minutes ofsleep latency), maintenance insomnia (frequent awakenings or inability to fall asleepafter awakening) or mixed insomnia
• Patients who are not on treatment or have not taken any dietary supplements orhypnotics for insomnia, or any other psychoactive drug in the past week.
• Patients able to understand the implications of the study and who demonstrate this byvoluntarily signing the informed consent DSM-5 diagnostic criterion for insomnia:

A. A predominant complaint of dissatisfaction with sleep quantity or quality, associatedwith one (or more) of the following symptoms:

1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiatingsleep without caregiver intervention.)
2. Difficulty maintaining sleep, characterized by frequent awakenings or problemsreturning to sleep after awakenings. (In children, this may manifest as difficultyreturning to sleep without caregiver intervention.)
3. Early-morning awakening with inability to return to sleep. B. The sleep disturbancecauses 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 ispresent for at least 3 months. E. The sleep difficulty occurs despite adequate opportunityfor sleep. F. The insomnia is not better explained by and does not occur exclusively duringthe course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleepdisorder, a circadian rhythm sleep-wake disorder, a parasomnia).

G. The insomnia is not attributable to the physiological effects of a substance (e.g., adrug of abuse, a medication).

H. Coexisting mental disorders and medical conditions do not adequately explain thepredominant complaint of insomnia.

Exclusion Criteria:

• Pregnant or nursing women
• Patients with other sleep disorders: narcolepsy, obstructive apnea, circadian rhythmdisorder, parasomnias
• Patients with active psychiatric disorders or cognitive impairment
• Patients with serious diseases that, in the physician's opinion, could interfere withthe results of the study or disadvise their participation in it
• Patients who do not give their written consent
• Patients with known hypersensitivity or intolerance to any of the active ingredientsor components of the dietary supplement or placebo.