Published: 30 June 2025
Revised 15 October 2025
Information for Industry
Improved access to approved medicines containing melatonin
Update October 2025
A change to the classification of melatonin on 10 October 2025 enables approval of products that may be supplied to adults aged 18 years and over without a consultation with a doctor or pharmacist, for short-term treatment of primary insomnia. This expands on the classification change in June 2025 that enabled supply of approved products for adults aged 55 years and over.
Although all currently approved melatonin medicines are indicated for those aged 55 and over, this most recent classification change will enable companies to apply for approval of medicines adults aged 18 and over. Once approved, these products will be able to be supplied without consultation from a doctor or pharmacist.
Pharmacists can still supply larger packs of melatonin, up to 13 weeks supply, to an adult 55 years of age or over for insomnia, following consultation. Melatonin containing medicines are also available on prescription for those who use melatonin longer term.
In July 2025, companies applied for approval of the first melatonin products for sale from pharmacy without a consultation with a doctor or pharmacist. Medsafe approved these in September 2025.
| Product | Dose form and strength | Use | Classification |
|---|---|---|---|
| Vigisom | Modified release tablet Melatonin 2 mg | Treatment of insomnia in adults aged 55 years and over | Pharmacy-only |
| Melotin | |||
| APOHEALTH Melatonin | |||
| SomniCare Melatonin |
All approved melatonin products can be found using the Product/Application search function here:
https://www.medsafe.govt.nz/regulatory/dbsearch.asp.
Companies can now apply for approval of medicines containing melatonin for supply to adults aged 18 years or over from pharmacy, for short term use, without a consultation with a doctor or pharmacist.
Medsafe has not received applications for approval of melatonin medicines for jetlag, there are no approved products at any classification.
Companies intending to make an application for approval can refer to the guidance here (Word Document, 30KB, 1 page), and contact medsafeapplications@health.govt.nz with any questions.
Those intending to import a supply of unapproved melatonin for personal use will still need a prescription to do so. Medsafe advises caution when importing unapproved medicines and products from overseas, due to the risk of these medicines being of poor quality, variable potency, contaminated or containing undisclosed ingredients.
Pharmac decides what medicines to fund in New Zealand, Melatonin is not a funded medicine for most people.
