Sleep and stress supplements: developing one in Australia

The claims a sleep or stress product can make

A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and nervous system indications sit in Part 8. Indications can be qualified by population, time of use or tradition, and the evidence for each one is held by the sponsor (permitted indications).

A label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. "Serious" takes its meaning from section 28 of the Therapeutic Goods Advertising Code: a form that needs a health professional to diagnose, follow up or treat. A claim that refers to one is a restricted representation, which needs the TGA's prior approval (TGA advertising).

Why melatonin isn't in supplements here

In Australia, melatonin for human use is a Schedule 4 (prescription) medicine. The only exception is a Schedule 3 (pharmacist only) entry, in effect since 1 June 2021: modified-release tablets containing 2 mg or less of melatonin, on its own, for the short-term treatment of primary insomnia characterised by poor quality of sleep in adults aged 55 or over, in packs of no more than 30 tablets. Anything outside that entry stays in Schedule 4. So a sleep product sold as a supplement is built on other ingredients.

What the TGA has said about ashwagandha

Ashwagandha (Withania somnifera) is one of the most used ingredients in stress products, including our own work. The TGA issued a safety advisory in 2024 about a possible risk of liver injury with medicines containing it. In its update, the TGA said it had received four further adverse event reports suggesting possible liver injury since that advisory, all of which resolved after the product was stopped, none needing hospital.

The TGA's advice to consumers is to be aware of possible gastrointestinal side effects and, in very rare cases, the possible risk of liver injury; to stop taking the product and seek medical advice if symptoms such as yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, abdominal pain or loss of appetite appear; and for people who have or have had liver problems to avoid medicines and herbal supplements containing it.

For a brand, that means checking the current conditions on the ingredient in the Permissible Ingredients Determination at the brief (permissible ingredients), choosing a well-characterised extract with studies at the dose used, and keeping the TGA's safety information in view when writing the label and the marketing.

Building on clinically studied ingredients

Branded extracts with their own clinical studies are common in this category: KSM-66® ashwagandha and affron® saffron are two in our records. A branded ingredient can carry much of a product's evidence, if its studies match the product's dose, form and population (branded ingredients). A formula with many ingredients needs evidence behind each: the 32-day capsule's evidence package covered more than 13.

From our records

• A KSM-66® ashwagandha capsule in 32 days: a complex herbal formula for a founder-led start-up, built around KSM-66®, a clinically studied ashwagandha extract, on a tight timeline. The formula, an evidence package covering more than 13 ingredients, the TGA listing and a long-term stability program. Design to production order in 32 days.
• EverLeanBody: a four-ingredient daily capsule for women 35 and over, built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. 5.8 months from signed brief to dispatch.
• Ora: our founder's own brand, with a sleep, stress and recovery range among around 19 products built on ingredients including affron® and KSM-66®.