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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of four different nutritional supplements on sleep in healthy adults. Participants will be randomly assigned to one of five groups, including a placebo group, to compare results over a 12-week period. This study suits individuals who have trouble sleeping but lack diagnosed sleep disorders and can maintain their usual diets and routines. As a Phase 1 trial, the research focuses on understanding how these supplements work in people, offering participants the unique opportunity to be among the first to receive this treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that melatonin, the main ingredient in Sleep Supplements 1, 2, 3, and 4, is generally safe for short-term use. Studies have found that melatonin usually doesn't lead to dependency, unlike some other sleep medications. However, limited information exists on its long-term safety. Some research hints at a possible connection between long-term melatonin use and heart problems, but this doesn't confirm causation. Most people experience few side effects, similar to those taking a placebo. Overall, these supplements appear well-tolerated for short-term use, but the long-term effects remain under study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these sleep supplements because they offer potential new ways to tackle sleep issues. Unlike typical sleep aids that often rely on sedative properties, these supplements might include unique natural ingredients or innovative formulations that work differently to promote restful sleep. Such differences could lead to fewer side effects or dependencies, setting them apart from standard medications like melatonin or prescription sleep aids. By targeting sleep quality in various ways, these supplements could potentially provide faster and more effective relief for those struggling with sleep problems.

What evidence suggests that this trial's treatments could be effective for sleep?

This trial will evaluate the effectiveness of different sleep supplements. Research has shown that Sleep Supplement 1, which participants in this trial may receive, can improve sleep by helping individuals fall asleep more quickly and wake up less often. Sleep Supplement 2, another option in this trial, also demonstrated benefits, with melatonin and other ingredients enhancing sleep and reducing the time to fall asleep. Sleep Supplement 3, also under study, has been linked to better sleep and fewer disturbances. Studies on Sleep Supplement 4, another treatment arm, indicate it helps people fall asleep faster and improves overall sleep, with melatonin playing a key role. Overall, these supplements have shown positive effects on sleep in various studies. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11082867/

Current Evidence on Common Dietary Supplements for ...

“The supplement group exhibited enhanced sleep quality, reduced sleep latency, and decreased sleep disturbances.” A quick internet search on “ ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1087079225000292

The effects of L-theanine consumption on sleep outcomes

Significant improvement in sleep onset latency (mean reduction −24 ± 25 min; p = 0.002); total sleep time (mean increase of 22 ± 32 min; p = 0.01) and sleep ...

3.

academic.oup.com

academic.oup.com/sleep/article/48/Supplement_1/A597/8135569

1389 Effects of a Supplement System on Objectively ...

Compared to a control, the supplement system was associated with falling asleep faster, waking up less often, spending less time awake during ...

4.

sleepfoundation.org

sleepfoundation.org/sleep-aids/natural-sleep-aids

Natural Sleep Aids: Which Are the Most Effective?

Limited evidence suggests that taking 300 to 600 milligrams of valerian up to an hour before bedtime can help people fall asleep and improve ...

5.

nature.com

nature.com/articles/s41598-024-58661-z

Effect of a nutraceutical combination on sleep quality ...

Among adults with impaired sleep, a nutraceutical combination did not improve objective or subjective sleep parameters more than a placebo infusion.

6.

newsroom.heart.org

newsroom.heart.org/news/long-term-use-of-melatonin-supplements-to-support-sleep-may-have-negative-health-effects

Long-term use of melatonin supplements to support sleep ...

The association between melatonin and increased risk of heart failure or death found in this study, which cannot prove a cause-and-effect ...

7.

fishersci.com

fishersci.com/store/msds?partNumber=AAJ6245206&productDescription=MELATONIN+5G&vendorId=VN00024248&countryCode=US&language=en

SAFETY DATA SHEET

This product does not contain any hazardous materials with occupational exposure limitsestablished by the region specific regulatory bodies. Wear appropriate ...

8.

consumerreports.org

consumerreports.org/dietary-supplements/natural-sleep-supplements-serious-safety-concerns/

Natural' Sleep Supplements Carry Serious Safety Concerns

There's little research to suggest melatonin and valerian work, plus the popular supplements come with clear risks.

9.

spectrumrx.com

spectrumrx.com/media/sds/M2095_AGHS.pdf

SAFETY DATA SHEET

First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated ...

10.

cdn.caymanchem.com

cdn.caymanchem.com/cdn/msds/14427m.pdf

Safety Data Sheet

Boiling point/Boiling range: Undetermined. Flammability: Product is not flammable. Explosion limits: Lower: Not determined.