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

Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03814135
Enrollment
0
Registered
2019-01-23
Start date
2021-01-31
Completion date
2022-03-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

insomnia

Brief summary

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

Interventions

DRUGHipnos 3

1 tablet, oral, once a day.

DRUGHipnos 5

1 tablet, oral, once a day.

OTHERHipnos 5 Placebo

1 tablet, oral, once a day.

OTHERHipnos 3 Placebo

1 tablet, oral, once a day.

Sponsors

EMS
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Duble-blind and double-dummy

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.4 weeks

Secondary

MeasureTime frame
Incidence and severity of adverse events recorded during the study.5 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026