Agomelatine

Regulated restrictive practice · chemical restraint reference

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Agomelatine · RP Check

§01

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 Agomelatine 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.
  ↗ACT Office of the Senior PractitionerT3✓
- Statutory anchor: Agomelatine 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.
  ↗Senior Practitioner Act 2018 (ACT)T3✓
NSW1 citation
- In New South Wales, use of Agomelatine 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.
  ↗NSW DCJ Restrictive Practices AuthorisationT3✓
NT1 citation
- In the Northern Territory, use of Agomelatine 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.
  ↗Northern Territory NDIS Restrictive Practices AuthorisationT3✓
QLD4 citations
- In Queensland, use of Agomelatine 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.
  ↗Queensland Office of the Public GuardianT3✓
- In Queensland, use of Agomelatine 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.
  ↗Queensland Department of Families, Seniors, Disability Services and Child SafetyT3✓
- Statutory anchor: substitute decision-making for Agomelatine 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.
  ↗Guardianship and Administration Act 2000 (Qld)T3✓
- Statutory anchor: Agomelatine 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.
  ↗Disability Services Act 2006 (Qld)T3✓
SA2 citations
- In South Australia, use of Agomelatine 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.
  ↗SA Restrictive Practices Authorisation SchemeT3✓
- Statutory anchor: Agomelatine 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.
  ↗Disability Inclusion Act 2018 (SA)T3✓
TAS2 citations
- In Tasmania, use of Agomelatine 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.
  ↗Tasmanian Senior Practitioner (Disability)T3✓
- Statutory anchor: Agomelatine 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.
  ↗Disability Rights, Inclusion and Safeguarding Act 2024 (Tas)T3✓
VIC2 citations
- In Victoria, use of Agomelatine 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.
  ↗Victorian Senior PractitionerT3✓
- Statutory anchor: Agomelatine 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.
  ↗Disability Act 2006 (Vic)T3✓
WA1 citation
- In Western Australia, use of Agomelatine 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.
  ↗WA Department of CommunitiesT3✓

§02

↗TGA PIT1✓

TGA-approved indications

major depressive disorder (MDD) including prevention of relapse
generalised anxiety disorder (GAD)

§03

Adverse effects

Common (top 5)

↗TGA PIT1✓

Headache
Nausea
Nasopharyngitis
Dizziness
Somnolence

Serious

§04

↗TGA PIT1✓

Contraindications

with a history of previous hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 - List of excipients.
with hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 times the upper limit of normal (see section 4.2 - Dose and method of administration and section –4.4 Special warnings and precautions for use ).
taking potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin).

§05

Mechanism & pharmacology

“Agomelatine is a melatonin receptor (MT 1 and MT 2 ) agonist and 5-HT 2C receptor antagonist.”
↗TGA PIT1✓

“The mean plasma half-life is between one and two hours.”
↗TGA PIT1✓

“AGOMELATINE-WGR (agomelatine) is metabolised mainly by cytochromes CYP1A2 (90 %) and CYP2C9/19 (10 %).”

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At a glance

Also known as

Jurisdictional framework

TGA-approved indications

Adverse effects

Common (top 5)

Serious

Contraindications

Mechanism & pharmacology