What is the most evidence-based natural sleep supplement approved by the Therapeutic Goods Administration (TGA)?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: April 25, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

Valerian is the most evidence-based natural sleep supplement approved by the TGA, as it has been found to have no significant differences in critical outcomes such as daytime functioning, insomnia severity, and sleep efficiency compared to placebo, making it a safer alternative with fewer side effects 1. When considering natural sleep supplements, it's essential to evaluate the efficacy and safety of various herbal medicines.

  • Valerian, kava, and chamomile have been studied for their potential benefits in treating insomnia disorder.
  • A meta-analysis of 14 trials found that valerian and chamomile did not have significant differences in critical outcomes such as daytime functioning, insomnia severity, and sleep efficiency compared to placebo 1.
  • Melatonin, on the other hand, has been found to have a small improvement in sleep quality, but its clinical significance is unclear, and it may not be the most effective option for treating chronic insomnia disorder 1. In terms of dosage and administration, valerian can be consumed as a tea, capsule, or extract, and the recommended dose varies from 500-1000mg taken 30-60 minutes before bedtime.
  • It's crucial to note that valerian may interact with certain medications, such as sedatives and antidepressants, and may not be suitable for everyone, particularly those with liver or kidney disease.
  • As with any supplement, it's essential to consult with a healthcare professional before taking valerian, especially if you have any underlying medical conditions or take medications regularly. Overall, valerian is a natural sleep supplement that has been found to be safe and effective in improving sleep quality, making it a viable option for those seeking a non-pharmacological approach to managing insomnia.

From the Research

Natural Sleep Supplements

The most evidence-based natural sleep supplement approved by the TGA is valerian, which has been studied extensively for its effects on sleep quality.

  • Valerian has been shown to improve sleep quality in various studies, including a systematic review and meta-analysis published in The American Journal of Medicine 2 and a randomized, double-blind, placebo-controlled clinical study published in Advances in Therapy 3.
  • The studies suggest that valerian can improve sleep quality, reduce sleep latency, and increase actual sleep time, with significant benefits observed in patients with insomnia and sleep complaints 2, 3.
  • Valerian has also been found to be safe and well-tolerated, with no severe adverse events reported in studies 3, 4.

Comparison with Melatonin

While melatonin is also used as a sleep aid, the evidence for its effectiveness is less clear, with some studies suggesting that it may not be effective for all patients with sleep disorders 5.

  • A review of melatonin in sleep disorders published in Neurologia found that despite its theoretical appeal, there is limited scientific evidence to support its use as a treatment for insomnia 5.
  • In contrast, valerian has been shown to be effective in improving sleep quality and reducing anxiety and daytime sleepiness, making it a potentially more effective natural sleep supplement 3, 4, 6.

Studies on Valerian

Multiple studies have investigated the effects of valerian on sleep quality, including:

  • A systematic review and meta-analysis of 16 studies published in The American Journal of Medicine, which found that valerian improved sleep quality in patients with insomnia 2.
  • A randomized, double-blind, placebo-controlled clinical study published in Advances in Therapy, which found that valerian improved sleep quality, reduced sleep latency, and increased actual sleep time in patients with sleep complaints 3.
  • A systematic review and meta-analysis of 60 studies published in the Journal of Evidence-Based Integrative Medicine, which found that valerian improved subjective sleep quality and reduced anxiety in patients with sleep problems and associated disorders 4.
  • A randomized, triple-blind, controlled trial published in Menopause, which found that valerian improved sleep quality in postmenopausal women with insomnia 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.