Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

Double-blind, Randomized, Placebo and Active Controlled Study to Assess the Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults(Zolpidem or Brotizolam)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071889

Enrollment

Registered

2010-02-19

Start date

2010-05-31

Completion date

2013-07-31

Last updated

2015-01-30

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

Conditions

Healthy

Keywords

Healthy Volunteers

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data. In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.

Interventions

DRUGFlumazenil

Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration

DRUGPlacebo

Placebo - only excipients with no API

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure. 2. Male or female aged 18-65 at screening. Women of childbearing potential must have a negative pregnancy test at the screening visit and use a reliable method of contraception during the entire study duration (e.g. Contraceptive pill; Intra-uterine device; Contraceptive injection (prolonged-release gestagen); Subdermal implantation;Vaginal ring or Transdermal patch). 3. Body mass index ≥ 18.5 and \< 32 kg/m2. 4. Normal sleep habits, i.e. usual self-reported total sleep time \> 6 h; usual self-reported time to fall asleep \< 30 min; usual bedtime between 10:30 pm and 01:00 am. 5. Subject is in good health as determined by a medical history, physical examination and ECG. 6. Negative any use of illicit drug, alcohol (ethanol), stimulants.

Exclusion criteria

1. Any use of medications within 1 month prior to screening visit, except for contraceptive pills. 2. Any sleep associated complains. 3. Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation. 4. History of Epilepsy and or anti-epileptic drugs. 5. Excessive caffeine consumption (≥ 500 mg per day). 6. Pregnancy or breast feeding. 7. Night shift workers within 1 month prior to the screening visit. 8. Clinically relevant ECG abnormalities. 9. History of alcohol or drug abuse within 3 years prior to the screening visit. 10. Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit. 11. Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation. 12. Treatment with another investigational drug within 1 month prior to the screening visit. 13. History of severe head injury.

Design outcomes

Primary

Measure	Time frame
Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs	6 months

Secondary

Measure	Time frame
Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs	6 months

Countries

Israel

Outcome results

None listed

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