An interventional study of S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate in Sleep Disturbance, sponsored by Bonafide Health. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Bonafide Health (part of Otsuka Holdings Co., Ltd.) · Not applicable, Interventional, and Treatment
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.
This is an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep quality and related well-being in perimenopausal and postmenopausal women with sleep complaints. The study was designed to enroll approximately 150 women aged 40 to 65 from across the United States. All participants received the study supplement, and all study procedures were conducted remotely.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep complaints, and eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days to familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in period, participants initiated the intervention on Day 1 and self-administered the study product once daily through approximately Day 85. The study product was administered orally as two tablets approximately 60 minutes before bedtime. Participants continued supplementation for approximately 12 weeks through the End of Intervention visit.
Throughout the intervention period, participants completed electronic questionnaires assessing sleep quality and related sleep and well-being complaints. Sleep quality was assessed regularly using visual analog scales, and sleep and well-being complaints were assessed at protocol-defined intervals. Participant experience with the study product was also evaluated near the end of the intervention period.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Study assessments continued during this period to characterize changes following discontinuation, and participants completed a washout questionnaire at the End of Study visit.
All study visits and assessments were conducted remotely through virtual or telephone visits. Safety and tolerability were monitored throughout participation through participant reporting and scheduled study contacts. Each participant's total duration of participation was approximately 18 to 19 weeks, including screening, run-in, intervention, washout, and end-of-study assessments.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 111 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Bonafide Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
First submitted after Bonafide Health became part of Otsuka Holdings Co., Ltd..
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113.
Dietary Supplement: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
Drug page: S-Adenosylmethionine
A daily dietary sleep supplement taken once per day for 85 days.
Also known as: Bonafide Sleep
Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported difficulty leaving bed and beginning the day, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no difficulty, while a score of 100 indicates extreme difficulty that is nearly impossible to overcome. Lower scores indicate greater ease beginning the day.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Sleep-Onset Latency as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported time required to fall asleep, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates falling asleep almost immediately, while a score of 100 indicates substantial difficulty falling asleep. Lower scores indicate easier sleep initiation.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported frequency of sleep disturbances measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no sleep disturbances and peaceful sleep every night, while a score of 100 indicates constant sleep disturbances every night. Lower scores indicate fewer sleep disturbances.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported difficulty returning to sleep after awakening during the night, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no nighttime awakening, while a score of 100 indicates finding it very difficult or impossible to fall back asleep. Lower scores indicate better sleep maintenance.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Mental Confusion as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported mental confusion upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no mental confusion and clear, focused thoughts, while a score of 100 indicates intense mental confusion and substantial difficulty achieving clarity. Lower scores indicate less mental confusion.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported morning grogginess measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no grogginess and feeling fully alert upon waking, while a score of 100 indicates intense morning grogginess with marked drowsiness and lethargy. Lower scores indicate less morning grogginess.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Restfulness or Rejuvenation as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported restfulness or rejuvenation upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling fully rested and rejuvenated, while a score of 100 indicates no sense of restfulness or rejuvenation. Lower scores indicate greater restfulness.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Deep Sleep as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported experience of deep, restorative sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates consistently experiencing deep, uninterrupted, restorative sleep, while a score of 100 indicates experiencing no perceived deep sleep. Lower scores indicate greater perceived deep sleep.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported daytime sleepiness measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling alert and energetic without daytime sleepiness, while a score of 100 indicates an overpowering urge to sleep or nap. Lower scores indicate less daytime sleepiness.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Sleep Satisfaction as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported satisfaction with sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates being extremely satisfied with sleep, while a score of 100 indicates being extremely dissatisfied. Lower scores indicate greater sleep satisfaction.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported overall sleep quality measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent sleep quality, while a score of 100 indicates extremely poor sleep quality. Lower scores indicate better sleep quality.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Overall Quality of Life as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported overall quality of life measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent quality of life and complete satisfaction, while a score of 100 indicates extremely poor quality of life and no satisfaction. Lower scores indicate better perceived quality of life.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Sleep and Well-Being Complaints Questionnaire Responses
Change from baseline in participant-reported sleep and well-being complaints. The questionnaire assesses sleep initiation and latency, sleep maintenance and quality, morning refreshment and energy, daytime functioning and cognitive clarity, and emotional and physical well-being. Individual complaints are assessed as present or absent, with severity rated from 0 to 100 when a complaint is endorsed.
Time frame: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 28 days
Participant Experience With the Study Product
Participant responses to the Product Experience Questionnaire assessing overall satisfaction with the study product, ease of use, perceived effects on sleep and daytime functioning, overall product experience, and willingness to recommend or continue using the product. Scored Likert items range from 1 (Strongly Disagree) to 4 (Strongly Agree), with higher scores indicating a more favorable product experience. Selected items include 0 = Not Applicable, which is not treated as a scored response. Additional items use Yes/No/Not Applicable or open-text responses. No composite total score is calculated; responses are summarized by individual item.
Time frame: Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)
Participant-Reported Changes Following Study Product Discontinuation
Participant responses to the Washout Questionnaire assessing perceived changes following discontinuation of the study product, including sleep quality, daytime restfulness and energy, cognitive function, mood, overall satisfaction, perceived product benefit, and likelihood of recommending the product. The questionnaire uses item-specific ordered categorical response options, including 4-level responses (e.g., Very Dissatisfied to Very Satisfied; Strongly Disagree to Strongly Agree) and 5-level responses (e.g., Not Effective to Very Effective; Much Worse to Much Better; Definitely Not to Definitely Yes). More favorable response categories indicate a more favorable perceived outcome. No composite total score or single minimum/maximum questionnaire score is calculated; responses are summarized by individual item.
Time frame: Week 16 (Day 113 ±3 days), following approximately 4 weeks of study product discontinuation
Plan to share: No
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Studies of the drug tested here: S-Adenosylmethionine
Sleep Initiation and Maintenance Disorders →