Sponsor decision

The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.

Inclusion Criteria:

• Participants aged 50 years or more;
• Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
• Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Known hypersensitivity to the formula components used during the clinical trial;
• Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
• History of hepatic impairment;
• Current smoking;
• Pregnancy or risk of pregnancy and lactating patients;
• History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
• Diagnosis of clinical diseases that interfere with sleep;
• Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
• Participation in clinical trial in the year prior to this study.

Duble-blind and double-dummy