Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

EMS

Status and phase

Not yet enrolling

Phase 3

Conditions

Chronic Insomnia

Treatments

Drug: Sublingual Tablet

Study type

Interventional

Funder types

Industry

Identifiers

EMS0222- SERENA

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

Enrollment

358 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Age between 18 to 64 years;
Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
Participants with difficulty in initiating or maintaining sleep parameters.

Exclusion criteria

Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
Known hypersensitivity to any of the formula compounds;
Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
Participants using sedatives or hypnotic medications;
Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
Participants with history of drug and alcohol abuse in the past 2 years;
Participants with current smoking habits during the night period;
Participants who treated insomnia in the last 3 months;
Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
Participants with current or medical history of cancer in the last 5 years;
Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.