Ashwagandha for Nighttime Waking

Each participant will be in the study for about 5 weeks (1 preparation week and 4 weeks for the trial). Questionnaires consist of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.

Inclusion criteria

• Age: Male and non-pregnant female adult participants must be between 18 and 65 years of age.
• Female subjects of childbearing potential must be using a medically acceptable form of birth control, as there are unknown pregnancy risks when starting any new supplement.
• Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy and/or bilateral oophorectomy.
• Sleep Quality: Otherwise, healthy individuals with a raw score of 25-29 (T-score of approximately 55.0-59.9) on the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a, indicating at least mild sleep disturbance.
• Sleep Hygiene: Willing to follow basic sleep hygiene protocols (dark/dim lights, quiet location/white noise, regular sleep routine, abstaining from digital activity 1 hour prior to sleep) during the Baseline week and the 28-day trial.
• Wearable Device: Participants must be willing to comply with study procedures, including wearing the Oura Ring nightly (at least 4 nights per week) and completing questionnaires.
• Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.
• Willing to wear the Oura Ring for a total of 35 days (7-day base + 28 days of trial)
• Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.
• Willing to refrain from using sleep-promoting supplements or medications during the study, such as melatonin, antihistamines, valerian root, chamomile, magnesium, and cannabinoids (CBD).
• Results of screening procedures/ lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
• Willing to undergo study procedures including safety lab tests and urine pregnancy test (UPT only for women of childbearing potential).

Exclusion criteria

• Age: Participants younger than 18 and older than 65 years of age.
• Use of Medications: Current use of sleep-promoting or sleep-disrupting medications or supplements.
• Diagnosed Sleep Disorder: Sleep apnea, narcolepsy, or other for which they are taking medication.
• Other Conditions: Significant medical or psychiatric conditions that could interfere with sleep assessment.
• Irregular Sleep Schedules: Shift workers or those with irregular sleep schedules, as well as anyone with a newborn or having a lifestyle likely to interfere with sleep patterns (eg: jet lag).
• Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 30 days.
• Post-menopausal female subjects on any Hormone Replacement Therapy
• Allergies: Known allergy or hypersensitivity to any component of the study product.
• Alcohol Intake: History or presence of excessive alcohol use (> 8 drinks per week in women and > 15 drinks per week in men within the past month) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or addiction to nicotine (current smokers/tobacco users)
• Chronic Illness: Participants with chronic conditions such as liver disease, kidney disease, or severe cardiovascular disease or cancer, colorectal disease and/or other rare disorders that at the discretion of the Principal Investigator (PI) or Clinical Investigator (CI) may impact their safety or confound trial results
• Other Medications: Subjects taking insulin, psychotropics, anxiolytics, sedatives, hypnotics or herbal supplements / Over the counter (OTC) product / multivitamins etc. for sleep or anxiety or any other psychological condition, or any other prescription product which has a known side effect of causing somnolence or sleep problems, within one month prior to the screening visit.
• High-risk medications: The use of any high-risk medications with narrow therapeutic indices metabolized by cytochrome (CYP450) enzymes: Warfarin (CYP2C9), Tacrolimus/Cyclosporine (CYP3A4), Efavirenz (CYP2B6), and Codeine (CYP2D6).
• Drugs requiring activation for efficacy: Clopidogrel (CYP2C19), Codeine (CYP2D6), and Tamoxifen (CYP2D6).
• Participation in Other Trials: Currently participating in another interventional research study or participated in another interventional research study within 90 days of screening
• Any condition that in opinion of the Investigator, does not justify the Subjects' participation in the study.