The Effect of Avnace eZZe on Sleep Improvement

Inclusion criteria

• Male or female age 18 years or older;
• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder;
• Regular bedtime, between 21:00 and 01:00 and regular wake time;
• Insomnia Severity Index (ISI) score ≥15;
• All medications or interventions for insomnia, mental or physical disorders must have been stable for at least four weeks prior to screening, and participants had to be willing to maintain a stable regimen throughout the study;
• No consumption of sleep or stress-related supplements for at least four weeks prior to screening;
• Willing and able to comply with all aspects of the protocol.

Exclusion criteria

• A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder;
• Depressive symptoms at screening were considered significantly severe with a PHQ-9 score > 14
• Anxiety symptoms at screening were considered significantly severe with a GAD-7 score > 15;
• Females who are breastfeeding or pregnant;
• Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.);
• Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study;
• History of drug or alcohol dependency or abuse within approximately the previous 2 years;
• Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological, or psychiatric disease or malignancy or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments;
• Scheduled for major surgery during the study;
• Participants known to be allergic to any components of the product.