Melatonin shortage — NO supply status & alternatives

Melatonin

—

🇦🇺 AUST R 384006 · Teva Pharma Australia Pty Ltd

Anticipated · Australia

Anticipated · 🇦🇺 Australia & also short in🇳🇴 NO

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$55.00DPMQ A$71.73details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

June 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Melatonin
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Controlled substance	No

Marketing-authorisation holders	Teva Pharma Australia Pty Ltd, Sandoz Pty Ltd, Neo Health (OTC) Pty Ltd, Alphapharm Pty Ltd +3 more

Registrations on file	30

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$55.00

AEMP

Dispensed (DPMQ)

A$71.73

incl. fees

Pack

melatonin 1 mg modified release tablet, 60

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£2.13

Drug Tariff

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

4 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Moderate concentration risk

Flamma SPASwati Spentose Private LTDTechno (Fujian) Food Ingredients CO LTDSuzhou Yifan Pharmaceutical CO LTD

Manufacturing countries: Italy, India · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇳🇴

Norway

NOMA · 3d ago

Medium

🇦🇺

Australia

TGA · 2h ago

Resolved

Recalls official enforcement reports

🇺🇸

Melatonin

Synergy Rx · Feb 2017

Class IIdetails ↗

🇳🇿

Melatonin

Aug 2016

Class IIIdetails ↗

🇺🇸

Melatonin

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Melatonin

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Melatonin

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Verified timeline regulator events

🇳🇴 17 July 2026

medium reported

🇦🇺 15 June 2026

low reported

🇦🇺 13 June 2026

Shortage resolved

🇦🇺 8 June 2026

low reported

Sources official regulators

🇦🇺

TGA

verified 2h ago

verify ↗

🇳🇴

NOMA

verified 3d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Mr-Teva	2 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Mr-Tv	2 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Te-Melatonin Mr	2 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Wagner Health Melatonin	2 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
MELADOZZ melatonin	2 mg	—	🇦🇺 AU	—	Active
MELOSLEEP melatonin	2 mg	—	🇦🇺 AU	Neo Health (OTC) Pty Ltd	Active
Viatris	2 mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
VOQUILY melatonin	2 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Link	2 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Link	3 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Link	5 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Link	1 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
VOQUILY melatonin	5 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
VOQUILY melatonin	1 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
IMMELA melatonin	1 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active

+15 more registrations on file

Mederti Drug Report

Generated 2 July 2026 · Australia market · 2 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.