Sleep Supplements for Sleep

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pharmavite LLC

Must not be taking: Sleep medications, Antidepressants

Disqualifiers: Pregnancy, High caffeine, Sleep disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

376 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, if you are currently taking prescribed sleep medications or medications that affect sleep, you will need to stop as they are not allowed in this study. Additionally, you must not have taken these medications in the past 4 weeks before joining the trial.

Is the sleep supplement generally safe for humans?

L-Theanine, a natural sleep aid found in tea leaves, is considered safe and does not cause daytime drowsiness or addiction. The no observable adverse effect level (NOAEL) for L-theanine is above 2000 mg/kg body weight per day, indicating it is safe at typical doses. ^{1 2 3 4 5}

How do sleep supplements differ from other treatments for sleep problems?

Sleep supplements are unique because they can be personalized based on individual life habits and sleep conditions, unlike standard treatments that may not consider these personal factors. They include ingredients like l-theanine, GABA, and Apocynum venetum leaf extract, which have shown significant improvement in sleep problems, especially when combined with certain dietary habits like consuming dairy products. ^{2 6 7 8 9}

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.

Eligibility Criteria

Healthy U.S. adults aged 18-65 with mild sleep issues can join this study. They must not have a history of substance abuse, high caffeine intake, or be on certain medications that affect sleep. Pregnant women and those not using effective contraception are excluded, as well as anyone with irregular work hours affecting sleep.

Inclusion Criteria

Be able to give written informed consent

Insomnia severity Index score ≤14

PROMIS Sleep Disturbance Questionnaire raw score ≥23

Exclusion Criteria

Has a history of drug and/or alcohol abuse

High caffeine intake, >400mg/day

Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four nutritional supplements or a placebo over a 12-week period

12 weeks

Visits at 0, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sleep Supplements

Trial Overview The trial is testing the impact of four different nutritional supplements on sleep quality over 12 weeks against a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets what treatment until the end.

Participant Groups

Group I: Sleep Supplement 3 Active Control 1 Intervention

Participants served Sleep Supplement 3

Group II: Sleep Supplement 4 Active Control 1 Intervention

Participants served Sleep Supplement 4

Group III: Sleep Supplement 1 Active Control 1 Intervention

Participants served Sleep Supplement 1

Group IV: Sleep Supplement 2 Active Control 1 Intervention

Participants served Sleep Supplement 2

Group V: Placebo Placebo Group 1 Intervention

Participants served placebo

Who Is Running the Clinical Trial?

Pharmavite LLC

Lead Sponsor

Trials

12

Recruited

27,200+

Findings from Research

Melatonin receptor agonists have the lowest rate of adverse events (43.1 per 1000), while non-benzodiazepine benzodiazepine receptor agonists have the highest (255.0 per 1000), indicating a significant difference in safety profiles among insomnia medications.

Benzodiazepines showed the highest efficacy in improving sleep outcomes with an effect size of 1.94, while melatonin receptor agonists had the lowest efficacy (0.109), suggesting that histamine antagonists may offer the best risk-benefit ratio for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. Cheung, JMY., Scott, H., Muench, A., et al.[2023]

About 50% of people will experience a sleep disorder in their lifetime, leading to growing interest in plant-based supplements for treatment.

The review evaluates the safety and effectiveness of six common sleep aids, including chamomile and valerian, highlighting that the quality of evidence supporting their use varies significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Nutraceutical Sleep Therapeutics and Investigational Research. Yurcheshen, M., Seehuus, M., Pigeon, W.[2023]

The use of herbal preparations for sleep issues among adults in the U.S. has significantly increased from 2.5% to 12.4% over the past decade, highlighting a growing interest in alternative remedies.

Health care professionals need to be informed about the pharmacological properties of commonly used herbal sleep aids and wake-promoting products to better educate their patients on safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Merritt, SL., Gyllenhaal, C., Peterson, SD., et al.[2015]

Low-dose melatonin treatment can effectively promote sleep onset and maintenance without altering sleep architecture, making it a useful option for individuals with insomnia or circadian rhythm disorders.

High doses of melatonin (over 0.3 mg) may lead to side effects and disrupt circadian rhythms, highlighting the importance of using physiologic doses and ensuring quality control in melatonin supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin, Circadian Rhythms, and Sleep. Zhdanova, IV., Tucci, V.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Updates on Nutraceutical Sleep Therapeutics and Investigational Research. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Update on the safety considerations in the management of insomnia with hypnotics: incorporating modified-release formulations into primary care. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

In Search of a Safe Natural Sleep Aid. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of the Effects of Known Sleep-Support Supplements in Relation to Life Habits, Sleep Conditions, and Sleep Problems. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of dietary supplements on improving sleep quality: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Melatonin, Circadian Rhythms, and Sleep. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. [2021]