The Science Behind Sleep Supplements: Clinical Guidance Amidst Regulatory Concerns

Sleep supplements have become a staple of patient conversations in sleep medicine — touted as quick fixes for sleepless nights and over-the-counter solutions to complex sleep disorders. Although prescription medications are a mainstay of sleep disorder treatment, many patients look to over-the-counter sleep supplements as a natural alternative.

But for clinicians, recommending — or even discussing — these supplements can feel like walking a tightrope. Unlike prescription medications, sleep supplements operate in a loosely regulated landscape, leaving providers with questions and concerns regarding the safety, efficacy, and quality of sleep supplements.

For a clinician’s perspective on the topic, we spoke with Tatiana Rivera Cruz, an LCSW from ADHD Advisor who counsels patients on sleep-related issues. Here is what we discovered about some of the most popular supplements for sleep.

Cruz explains that many popular sleep supplements contain natural compounds, like herbs, amino acids, or hormones. Some help regulate sleep patterns, while others reduce anxiety or manage pain. However, she emphasizes that even natural sleep supplements may have side effects like dizziness, headaches, or gastrointestinal discomfort. Her primary concern is that patients may seek sleep supplements without medical supervision or grow dependent on them.

Overall, the characteristics of the current regulatory framework for dietary supplements allow variability in quality specifications for comparable products and thus can contribute to a lack of consistency and transparency in product quality.

The Sleep Foundation has reviewed some of the most popular over-the-counter sleep supplements, finding potential benefits and noting contraindications.1

Melatonin

The Sleep Foundation found that 2 out of 3 American adults have tried this sleep-regulating hormone. Research suggests that melatonin may be most beneficial for those with jet lag, attention-deficit/hyperactivity disorder, menopausal night sweats, and sleep-onset insomnia. However, it is not recommended for those with depression, bleeding disorders, seizure disorders or for people who have had an organ transplant.1

Cannabis

The expansion of marijuana legalization has led to a boom in cannabis-based products marketed for various ailments, including sleep problems. There is some evidence that cannabis-based sleep supplements promote better sleep, particularly for people with chronic pain or post-traumatic stress. However, it is not safe to use cannabis with other sedatives. People with glaucoma, liver disease, and Parkinson disease should avoid cannabis.1

Magnesium

Most people get enough magnesium from food, but some choose to supplement their diets with the hope of better sleep. Magnesium can help people sleep longer and better, especially with aging. Side effects, like diarrhea, are usually minor. However, magnesium supplements may not be safe for those with impaired kidney function.1

Amino Acids

Tea leaves contain the amino acid L-theanine, which has been postulated to promote relaxation and lower stress. Although L-theanine does not make it easier to fall asleep, it may reduce the number of times people wake up throughout the night. It also avoids the common side effects of daytime sleepiness associated with many other sleep aids.1

Another amino acid, glycine, may regulate sleep-wake cycles when taken before bed. Glycine helps lower body temperature to prepare the body for sleep and has demonstrated efficacy even at small doses.1

Vitamin D

Known as the sunshine vitamin, it is no surprise that vitamin D is speculated to help regulate sleep-wake cycles. Experts have theorized that vitamin D receptors in the brainstem could play a role in sleep regulation by serving as pacemaker cells. Vitamin D may also affect melatonin levels, but this relationship has not been established.

In a meta-analysis of observational studies that used pooled data from 9397 participants, investigators found that vitamin D deficiency increased the likelihood of poor-quality sleep and sleep disorders by 1.5-fold. 2 Vitamin D deficiency was also associated with a 1.75-fold higher chance of short sleep duration and a 1.36-fold increase in sleepiness.2

While correcting a known deficiency is essential for better sleep and overall health, there is not enough evidence to promote vitamin D supplementation as a standalone treatment for sleep disorders.

Herbal Products

Herbal products have long been touted as sleep aids. For example, the stems and roots of the valerian plant are believed to improve sleep but may also cause lingering daytime drowsiness. Valerian does not work for everyone, however, as some individuals find that it actually keeps them awake. Valerian is one of the most researched plants for sleep disorders, but the results of these studies have produced mixed results.3

Lavender is another herb that has demonstrated promise for improving restlessness given its calming and anticonvulsant effects.3 In addition, hawthorne, chamomile, hop, Saint John’s wort, and rosemary are commonly sought out for sleep concerns, but have limited proven efficacy.

Regulation and Quality Control

“The regulatory landscape for sleep supplements is unstructured compared to pharmaceutical products,” explains Cruz. “In the United States, sleep supplements are classified as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994.4 This law means that sleep supplements can be sold by approval from the Food and Drug Administration (FDA) without demonstrating the safety or efficacy of the product in the market,” she says.

Cruz notes that sleep supplements are not subjected to rigorous testing and approval. As a result, they come with significant potential variability in ingredients and potency. While she admits that sleep supplements can be beneficial, the lack of regulation means consumers are not assured of a safe and effective product.

Despite these concerns, the supplement industry is booming. According to the American Medical Association (AMA), up to 80% of US adults take dietary supplements.4 The AMA warns clinicians, “Overall, the characteristics of the current regulatory framework for dietary supplements allow variability in quality specifications for comparable products and thus can contribute to a lack of consistency and transparency in product quality.” Given the potential for contamination and other drug interactions, dietary supplements are still a topic to be approached with caution.

Practical Advice for Clinicians

Cruz encourages clinicians to take a patient-centered approach to finding effective treatment options. Her first piece of advice is to assess sleep history and medical conditions. Then, she typically discusses the benefits and limitations of various sleep supplements, highlighting possible side effects. Once patients begin a sleep supplement, Cruz says it is crucial to continue monitoring and conduct routine follow-ups to monitor progress.

“It’s also important to consider modifications to the treatment plan that would benefit the patient’s well-being, lifestyle, and sleep hygiene,” explains Cruz. “In my interactions with clients, not all ask for sleep supplements, but those who do are more likely to discuss melatonin sleep supplements. During the discussion, many clients prefer this option because it is more accessible for them and because of the benefits of melatonin.”

Other interventions she has discussed with patients include deep sleep music, breathing exercises, and adjustments to the sleep routine. “These strategies help patients avoid side effects or dependencies at the moment of sleep. As clinicians, we discuss pharmaceutical and non-pharmaceutical options for clients to help them decide what would be a better fit.”

“The client should explore whether the situation is related to an unhealthy routine or medical condition. Then, whether pharmaceutical and non-pharmaceutical approaches that may help improve sleep,” says Cruz.

References:

  1. Bryan L, Cotliar D. Natural sleep aids: which are the most effective? Sleep Foundation. April 2024. Accessed January 9, 2025. https://www.sleepfoundation.org/sleep-aids/natural-sleep-aids
  2. Abboud M. Vitamin D supplementation and sleep: a systematic review and meta-analysis of intervention studiesNutrients. 2022;14(5):1076. doi:10.3390/nu14051076
  3. Guadagna S, Barattini DF, Rosu S, Ferini-Strambi L. Plant extracts for sleep disturbances: a systematic reviewEvid Based Complement Alternat Med. 2020;2020:3792390. doi:10.1155/2020/3792390
  4. Chaet Brykman, M, Streusand Goldman V, Sarma N, et al. What should clinicians know about dietary supplement quality? AMA Journal of Ethics. 2022;24(5):E382-389. doi:10.1001/amajethics.2022.382