Published: 30 June 2025

Information for Industry

Applications for approval of melatonin medicines

This is general guidance for companies wishing to submit a melatonin containing medicine application for consent to distribute in New Zealand. For specific questions contact medsafeapplications@health.govt.nz

The pharmacy-only classification of melatonin containing medicines is:

• Modified release dose forms 2 mg or less, indicated for the treatment of primary insomnia in adults aged 55 years and over, and in packs containing 30 dose units or less.
• Immediate release dose forms 3 mg or less, indicated for the treatment of primary insomnia in adults aged 55 years and over, and in packs containing 30 dose units or less.
• Immediate release dose forms 5 mg or less, indicated for the treatment of Jet Lag in adults 18 years and over, and in packs containing 10 dose units or less.

Approved medicines:

Several melatonin containing medicines are currently approved as Prescription Medicines. These approved products containing melatonin can be found on the Medsafe website:

Approved medicines containing melatonin

Product	Indication	Approval date
Circadin Modified release tablet, 2 mg	Monotherapy for the short term treatment (up to 13 weeks) of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.	2011
Melotin Modified release tablet, 2 mg		2019
Vigisom Modified release tablet, 2 mg		2021
APOHEALTH Melatonin Sleep Aid Modified release tablet, 2 mg		2024
SomniCare Modified release tablet, 2 mg		2024
Slenyto Modified release tablet, 1 mg, 5 mg	Insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.	2021

Determining the type of application needed to obtain approval for a Pharmacy-Only pack of oral melatonin

Modified release melatonin products for Insomnia in adults

Modified release dose forms containing melatonin 2 mg are approved as prescription medicines, for the treatment of insomnia in adults aged 55 or over. Applications for Pharmacy-Only packs containing modified release melatonin tablets 2 mg strength should be submitted under one of the following options:

L1 application for an additional classification, if:

• the proposed product is identical to a parent product listed in Table 1 in all respects other than the product name, classification, labelling and pack size
• AND the parent product complies with all current regulatory requirements
• AND the sponsor can demonstrate their right to access the parent product file
• AND the sponsor of the proposed product holds a full copy of the supporting data for the parent product (not required if the sponsor is the same for both products)
• AND the proposed age range is adults aged 55 and over.

L2 'generic' application:

• the product has not previously been approved by Medsafe
• AND the dose unit is a 2 mg modified release tablet
• AND it is indicated for the treatment of primary insomnia in adults aged 55 and over.

Sponsors should contact Medsafe for advice if seeking to submit applications for other product presentations, strengths, or indications.

Immediate release melatonin products for Jet Lag or Insomnia

Medsafe has not previously approved any melatonin containing medicines in immediate release dose forms, for any indication.

Therefore, until the first product is approved for a particular indication and/or strength, the data requirements for an L3 lower risk medicine will apply. Literature based submissions that meet TGA guidelines can be provided in lieu of new clinical trials to demonstrate safety and efficacy for the proposed indication and directions for use.

Bioequivalence

Medsafe is developing bioequivalence guidance for melatonin containing products and will update this document shortly.

Labels for Pharmacy-Only packs of melatonin

Sponsors should use Medsafe's guideline on the Labelling of medicines and related products to design appropriate labelling for Pharmacy-Only melatonin products. Medsafe supports harmonising with Australia where possible, including pack sizes for melatonin medicines that may be approved as pharmacy only medicines.

In addition to the Label Statements Database entries which apply to individual product formulations, additional safety statements will be required on the labels of Pharmacy-Only melatonin products.

For products that meet the criteria for submission under the L1 and L2 application categories, the following additional label statements will be required:

• Do not use if:
  • you are under 55 years of age
  • you are taking any other medicines for sleep
  • you have liver problems
  • you are pregnant or breastfeeding.
• Unless a doctor has told you to, do not use:
  • for more than 30 days
  • if you have kidney problems
  • if you have an autoimmune disease.
• Consult a pharmacist or doctor before use if you are taking other medicines regularly.
• Do not drink alcohol while taking this medicine.
• This medicine may cause drowsiness. If affected do not drive or operate machinery.

For L3 applications, modified statements as relevant to the proposed dose form, strength and indications will be required.