Ashwagandha for Insomnia

Overseen By Carina A Staab, DC, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National University of Natural Medicine

Must not be taking: Sleep aids, Psychotropics, Anxiolytics, others

Disqualifiers: Sleep apnea, Pregnancy, Alcohol use, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a lower-dosage Ashwagandha supplement can improve sleep. Participants will take either the supplement or a placebo daily for 28 days, with sleep monitored using an Oura ring. The goal is to determine if the supplement reduces time spent awake at night and enhances overall sleep quality. Individuals with mild sleep disturbances who can maintain a consistent sleep routine may be suitable for this study. As an unphased trial, it provides participants the chance to contribute to early research on enhancing sleep quality with natural supplements.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any sleep-promoting or sleep-disrupting medications or supplements, as well as certain other medications like insulin, psychotropics, and high-risk medications. The trial requires participants to refrain from using these during the study.

Is there any evidence suggesting that Ashwagandha is likely to be safe for humans?

Research has shown that Ashwagandha is usually safe for use up to three months, with most studies reporting only minor side effects, such as an upset stomach. More information is needed to determine its safety for longer periods, especially in larger amounts. Most research agrees that Ashwagandha can help improve sleep, but additional studies could provide a clearer picture of its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for insomnia, which often include medications like benzodiazepines or non-benzodiazepine sleep aids, Ashwagandha offers a natural alternative derived from a plant. Researchers are excited about this treatment because it uses a sustained-release, low-dosage formulation that may provide a gentler approach to improving sleep quality without the side effects commonly associated with conventional sleep medications. Additionally, Ashwagandha is believed to work by reducing stress and anxiety, which are often underlying causes of insomnia, offering a holistic approach to treatment. This makes it a promising option for those looking to address the root causes of their sleep issues.

What evidence suggests that Ashwagandha might be an effective treatment for insomnia?

Studies have shown that Ashwagandha can improve sleep quality. For instance, it helps those who often wake up tired by enhancing their sleep. Research also indicates that Ashwagandha can help people fall asleep faster and improve overall sleep quality. In this trial, participants will receive either a sustained-release Ashwagandha supplement or a placebo. Previous studies found that people taking Ashwagandha slept better and longer compared to those taking a placebo, which contains no active ingredients. These findings suggest that Ashwagandha might be helpful for sleep problems like insomnia. ^{3 4 6 7 8}

Who Is on the Research Team?

Joshua Goldenberg, ND

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

This trial is for individuals experiencing non-REM parasomnia or insomnia. Participants will be randomly chosen to take either an Ashwagandha supplement or a placebo for 28 days and must wear an Oura ring to monitor sleep disturbances.

Inclusion Criteria

Female subjects of childbearing potential must be using a medically acceptable form of birth control

Otherwise healthy individuals with a raw score of 25-29 on the PROMIS Sleep Disturbance Short Form 8a

Willing to follow basic sleep hygiene protocols during the Baseline week and the 28-day trial

Exclusion Criteria

Shift workers, individuals with irregular sleep schedules, or lifestyle likely to interfere with sleep patterns

Pregnant, lactating, or planning pregnancy within the next 30 days

Known allergy or hypersensitivity to any component of the study product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants take either an Ashwagandha supplement or a placebo daily for 28 days while wearing an Oura ring to measure sleep metrics.

4 weeks

Baseline visit and end of Week 4 visit

Follow-up

Participants are monitored for changes in sleep quality and other health metrics after the treatment phase.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ashwagandha

Trial Overview

The study aims to test if a low-dose (150mg) sustained-release Ashwagandha supplement can improve sleep quality compared to a placebo. Sleep disruptions are tracked using the Oura ring, and questionnaires assess life and sleep quality before and after the trial.

How Is the Trial Designed?

Group I: Sustained-Release Ashwagandha Supplement Experimental Treatment 1 Intervention

Sustained-release, lower-dosage (150mg) Ashwagandha supplement; 1 capsule 1 time per day.

Group II: Placebo Placebo Group 1 Intervention

Placebo Supplement: Consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day.

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8462692/

Effect of Ashwagandha (Withania somnifera) extract on sleep

Our meta-analysis of pooled data showed that Ashwagandha extract has significant improvement in overall sleep compared to placebo (SMD -0.59; 95 ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1389945720301246

A randomized, double blind, placebo controlled study to ...

Ashwagandha improved the quality of sleep, and reduced non-restorative sleep measures in healthy subjects with frequent non-restorative sleep. · Ashwagandha ...

3.

nutritionandmetabolism.biomedcentral.com

nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-00902-7

a review of its mechanisms, health benefits, and role in sports ...

Ashwagandha effectively improved overall sleep, compared to placebo, and specific measurements of sleep such as Sleep Quality Scale, sleep onset ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34559859/

Effect of Ashwagandha (Withania somnifera) extract on sleep

The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and ...

5.

cureus.com

cureus.com/articles/22928-efficacy-and-safety-of-ashwagandha-withania-somnifera-root-extract-in-insomnia-and-anxiety-a-double-blind-randomized-placebo-controlled-study

A Double-blind, Randomized, Placebo-controlled Study

Similarly, significant improvement in sleep quality was observed with test compared to placebo (p, 0.002). Significant improvement was observed ...

6.

ods.od.nih.gov

ods.od.nih.gov/factsheets/Ashwagandha-HealthProfessional/

Ashwagandha: Is it helpful for stress, anxiety, or sleep?

Ashwagandha appears to be well tolerated for up to about 3 months of use, but its long-term safety is not known. Common side effects (e.g., ...

7.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0257843

Effect of Ashwagandha (Withania somnifera) extract on sleep

However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would ...

8.

academic.oup.com

academic.oup.com/sleep/article/45/Supplement_1/A303/6592997

0694 Safety and Efficacy of Ashwagandha for sleep

In this systematic review, we study the efficacy of Ashwagandha in improving sleep and its safety for its users.