Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

• Status: Withdrawn
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS

Criteria

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.