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

Inclusion criteria

• The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
• 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).

• Body mass index ≥ 18.5 and < 32 kg/m2.
• 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.
• Subject is in good health as determined by a medical history, physical examination and ECG.
• Negative any use of illicit drug, alcohol (ethanol), stimulants.

Exclusion criteria

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