Bonafide Sleep Supplement for Menopausal Women With Sleep Complaints

This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints. All participants received the study supplement for approximately 12 weeks, followed by a four-week period without the supplement to assess changes after discontinuation. Sleep quality, sleep and well-being complaints, product experience, safety, and tolerability were assessed throughout the study.

Inclusion Criteria: * Healthy women who are 40 to 65 years of age (inclusive). * Have a body mass index (BMI) between 18.5 to 39.9 kg/m2 (inclusive). * Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 55 (equivalent to a raw score of 25). * Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days. * In good general health (no uncontrolled diseases or conditions) and able to consume the study product. * Agree to refrain from treatments listed in Section 12.4 in the defined timeframe. * Has stable access to Wi-Fi and an iPhone or Android device. * Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures. Exclusion Criteria: * Individuals who are lactating, pregnant, or planning to become pregnant during the study. * Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded. * Currently incarcerated prisoners. * Currently enrolled in a different clinical trial. * Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4. * Participants whose insomnia is predominantly attributed to significant medical, psychiatric, or environmental factors (e.g., restless leg syndrome, sleep apnea, chronic pain, anxiety, depression, or shift work) may be excluded, at the discretion of the investigator, if it is determined that these factors could interfere with study outcomes or participant safety. * Have a known sensitivity, intolerability, or allergy to the study product or their excipients. * History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study. * Major surgery in one month prior to screening or planned major surgery during the study. * Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant. Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).