At a glance
Also known as
↗ Brand list (Wikipedia)- MELATONIN ARX
- MELOMED
- MELOTIN
- Melatonin Viatris
- Melatonin MR-Teva
- MELOTIN MR
- Circadin
Jurisdictional framework
Select your state to see jurisdictional framework, reporting obligations, and authority links. Substance information above is the same in every state.
Restrictive practice framework8 states
ACT2 citations
- In the Australian Capital Territory, use of Melatonin as chemical restraint is regulated by the Senior Practitioner Act 2018 (ACT), which establishes the Office of the Senior Practitioner with independent oversight across disability services, education, residential care, and child protection. A Positive Behaviour Support Plan must justify the practice as the least-restrictive option, with active reduction strategies. The ACT framework's stated aim is the reduction and elimination of restrictive practices.
- Statutory anchor: Melatonin use as chemical restraint in the ACT is regulated by the Senior Practitioner Act 2018 (ACT). The Act's stated object is the reduction and elimination of restrictive practices and it applies broader-than-NDIS oversight: disability services, education, residential care, and child protection all sit within scope.
NSW1 citation
- In New South Wales, use of Melatonin as chemical restraint by a registered NDIS provider must be authorised under the NSW Restrictive Practices Authorisation framework administered by the Department of Communities and Justice (DCJ). Authorisation requires a Behaviour Support Plan documenting the practice, evidence that it is the least-restrictive option, and a documented reduction strategy. Psychotropic medications used as restraint should be reviewed at least every six months by a medical practitioner and at least every twelve months by a psychiatrist.
NT1 citation
- In the Northern Territory, use of Melatonin as chemical restraint by a registered NDIS service provider requires authorisation by the NT Senior Practitioner via the Restrictive Practice Authorisation System administered by NT Health. Applications must include the Behaviour Support Plan, evidence of consultation with the participant and relevant others, particulars of the providers applying the practice, and a summary of every restrictive practice applied in the preceding 12 months.
QLD4 citations
- In Queensland, use of Melatonin as chemical restraint on an adult with disability requires consent from a restrictive-practices guardian appointed by the Queensland Civil and Administrative Tribunal (QCAT), or short-term approval by the chief executive of the relevant disability service while a Positive Behaviour Support Plan is being developed. The Office of the Public Guardian acts as substitute decision-maker where appointed. Use must be the least-restrictive option to prevent serious harm and is subject to reduction planning.
- In Queensland, use of Melatonin as chemical restraint by funded disability service providers is governed by the Disability Services Act 2006 (Qld) and the positive behaviour support / restrictive practices framework administered by the Department of Families, Seniors, Disability Services and Child Safety. Authorisation must follow assessment by an appropriately qualified practitioner, a Positive Behaviour Support Plan, and the legislative tests of least-restrictive practice and reduction planning. Authorisation is granted per restrictive-practice type — separate authorisation is required for each.
- Statutory anchor: substitute decision-making for Melatonin use as chemical restraint on adults with impaired capacity in Queensland is governed by the Guardianship and Administration Act 2000 (Qld). Chapter 5B Part 4 sets out QCAT's powers to appoint a restrictive-practices guardian and the Office of the Public Guardian's role as substitute decision-maker.
- Statutory anchor: Melatonin use as chemical restraint by funded disability service providers in Queensland is regulated by the Disability Services Act 2006 (Qld), Chapter 5B of which sets out the positive behaviour support and restrictive-practice authorisation framework. The PBSRP Reform Bill 2024 lapsed in October 2024; the existing framework remains in force.
SA2 citations
- In South Australia, use of Melatonin as chemical restraint is a Level 2 restrictive practice under the SA Restrictive Practices Authorisation Scheme (in force from 30 May 2022) and can only be authorised by the Senior Authorising Officer — Authorised Program Officers cannot approve chemical restraint. Authorisation requires a Behaviour Support Plan, advice from a Specialist Behaviour Support Practitioner, and consultation with the participant and their family. The scheme is administered by the Restrictive Practices Unit within the Department of Human Services.
- Statutory anchor: Melatonin use as chemical restraint in South Australia is regulated by the Disability Inclusion Act 2018 (SA), with the operative detail in the Disability Inclusion (Restrictive Practices — NDIS) Regulations 2021. Together they establish the two-tier authorisation scheme (Authorised Program Officer for Level 1, Senior Authorising Officer for Level 2 including chemical restraint) in force from 30 May 2022.
TAS2 citations
- In Tasmania, use of Melatonin as chemical restraint by a disability service provider requires authorisation by the Tasmanian Senior Practitioner under the Disability Rights, Inclusion and Safeguarding Act 2024 (Tas). The Senior Practitioner authorises, oversees, and reports on restrictive practice use in NDIS-funded and Department of Communities Services–funded disability services, with a statutory requirement to protect the rights of people subject to restrictive practices to the greatest extent possible.
- Statutory anchor: Melatonin use as chemical restraint by disability service providers in Tasmania is regulated by the Disability Rights, Inclusion and Safeguarding Act 2024 (Tas), which establishes the Tasmanian Senior Practitioner with statutory powers to authorise, oversee, and report on restrictive-practice use in NDIS-funded and Department of Communities Services–funded disability services.
VIC2 citations
- In Victoria, use of Melatonin as chemical restraint requires authorisation by the Victorian Senior Practitioner under the Disability Act 2006 (Vic). Authorisation must satisfy the legislative tests of necessity to prevent harm, least-restrictive option, and a documented reduction plan.
- Statutory anchor: Melatonin use as chemical restraint in Victoria is regulated by the Disability Act 2006 (Vic), Part 7 of which establishes the Senior Practitioner role and the regulated-restrictive-practice authorisation framework. The Act's tests of necessity, least-restrictive option, and reduction planning are statutorily binding.
WA1 citation
- In Western Australia, use of Melatonin as chemical restraint requires authorisation through a Quality Assurance Panel under the WA Department of Communities Authorisation of Restrictive Practices framework (effective 1 December 2020). The panel must include at least two decision-makers: a senior manager from the implementing provider and an independent NDIS Behaviour Support Practitioner external to that provider who did not write the Behaviour Support Plan. Unlike single-administrator state models, the panel decision is the authorisation.
- ↗NDIS CommissionT2✓
- ↗NDIS ActT2✓
- ↗ACSQHC Psychotropic Medicines in Cognitive Disability or Impairment Clinical Care Standard (2024)T2✓
Mechanism & pharmacology
“The activity of melatonin at the MT1 MT2 receptors is believed to contribute to its sleep- promoting properties via their distinct actions on the circadian clock. The MT1 receptors are thought to inhibit neuronal firing, while the MT2 receptors have been implicated in the phase- shifting response.”
“Terminal half life (t½) is 3.5-4 hours.”
“Experimental data suggest that iso-enzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.”
TGA-approved indications
- Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over↗TGA PIT1✓
PBS-subsidised indications
- Insomnia↗PBST2✓
Show clinical criteria
Insomnia Clinical criteria: Treatment Phase: Initial Patient must have Smith-Magenis Syndrome confirmed by genetic testing, AND The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below). Treatment criteria: Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types. Population criteria: Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug. Definition: For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2 Definition:For the purposes of administering this restriction, impaired sleep is at least one of:(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; (ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval. Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient's medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing. The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals.
Adverse effects
Common (top 5)
- headache↗TGA PIT1✓
- nasopharyngitis↗TGA PIT1✓
- back pain↗TGA PIT1✓
- arthralgia↗TGA PIT1✓
- Diarrhoea↗TGA PIT1✓
Serious
- Angioedema↗TGA PIT1✓
- Hypersensitivity reaction↗TGA PIT1✓
- Syncope↗TGA PIT1✓
- Angina Pectoris↗TGA PIT1✓
- Leukopenia↗TGA PIT1✓
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
Contraindications
- patients with a known hypersensitivity to any ingredient of the product↗TGA PIT1✓
For family members and guardians
A plain-language summary of the cited sources below. Informational only — not medical advice.
Melatonin works by acting on two types of receptors in the brain called MT1 and MT2. The MT1 receptors help quiet down nerve activity, while the MT2 receptors help shift your family member's internal body clock. Together, these actions support the body's natural sleep-wake cycle. The medication stays active in the body for roughly three and a half to four hours before it's broken down by liver enzymes.
Doctors typically prescribe melatonin for insomnia — difficulty falling asleep or staying asleep. In Australia, it's formally approved for short-term use in people aged 55 and over who have poor-quality sleep, though it's sometimes used in other age groups as well.
Common side effects you might notice include headache, cold-like symptoms such as a runny or congested nose, back pain, joint pain, or diarrhoea. Most of these are mild, but let the prescribing doctor know if they become bothersome. Serious side effects are rare but can include swelling of the face or throat (angioedema), allergic reactions, fainting, chest pain, or a drop in white blood cells. If any of these occur, seek medical attention promptly. Melatonin should not be used if your family member has had an allergic reaction to it or any ingredient in the formulation in the past.
A Behaviour Support Practitioner reviewing melatonin will want to understand whether it's being used solely to address a sleep problem related to your family member's health, or whether it's also being used — even partly — to manage behaviours of concern. If the sleep medication is reducing behaviours because the person is calmer or more rested, that's generally appropriate support. If it's being used at doses or times primarily to sedate or suppress behaviour rather than treat the underlying sleep issue, it may meet the definition of a chemical restraint and require closer oversight.
For prescribers
A plain-language summary of the cited sources below. Informational only — not medical advice.
Melatonin is a melatonin receptor agonist acting at MT1 and MT2 receptors. Activity at MT1 receptors is thought to inhibit neuronal firing, while MT2 receptors have been implicated in phase-shifting responses, together contributing to sleep-promoting properties via actions on the circadian clock. The TGA-approved indication is monotherapy for short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or over; a broader 'insomnia' indication also appears in the source material.
Melatonin has a terminal half-life of 3.5–4 hours. Experimental data suggest metabolism involves cytochrome P450 iso-enzymes CYP1A1, CYP1A2, and possibly CYP2C19. Common adverse effects include headache, nasopharyngitis, back pain, arthralgia, and diarrhoea. Serious adverse effects documented include angioedema, hypersensitivity reaction, syncope, angina pectoris, and leukopenia. The product is contraindicated in patients with known hypersensitivity to any ingredient.
Working under the parallel aged-care framework? Aged-care equivalent →