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aripiprazole lauroxil

Long-acting injectable antipsychoticLAI available

Brands: ARISTADA, ARISTADA INITIO

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is aripiprazole lauroxil?

    Aripiprazole lauroxil (Aristada) is a long-acting injectable prodrug of aripiprazole for schizophrenia maintenance. It supports extended dosing intervals (monthly through every 2 months, depending on strength), which can reduce relapse risk driven by inconsistent daily medication use.

  • What is ARISTADA?

    ARISTADA is a brand name for aripiprazole lauroxil (other brands: ARISTADA INITIO).

  • What is ARISTADA (aripiprazole lauroxil) used for?

    Label indications include: Schizophrenia.

  • What drug class is ARISTADA (aripiprazole lauroxil)?

    Long-acting injectable antipsychotic.

  • What is the mechanism of action of ARISTADA (aripiprazole lauroxil)?

    Long-acting injectable prodrug of aripiprazole (D2/D3 partial agonist with 5-HT1A partial agonism and 5-HT2A antagonism) designed for extended dosing intervals to support adherence in schizophrenia maintenance.

  • What strengths does ARISTADA (aripiprazole lauroxil) come in?

    Intramuscular injection (interval varies by strength): monthly, every 6 weeks, or every 2 months per labeled schedules.

  • Is ARISTADA (aripiprazole lauroxil) a controlled substance?

    No — it is not scheduled as a controlled substance under U.S. federal law.

Snapshot

  • Class: Long-acting injectable antipsychotic
  • Common US brands: ARISTADA, ARISTADA INITIO
  • Long-acting injectable formulation available.
  • Therapeutic drug monitoring not routinely recommended; reference range 120–270 ng/mL.
  • Last reviewed: 2025-12-30

Label indications

Schizophrenia.

View labelExact

Clinical Highlights

Aripiprazole lauroxil (Aristada) is a long-acting injectable prodrug of aripiprazole for schizophrenia maintenance. It supports extended dosing intervals (monthly through every 2 months, depending on strength), which can reduce relapse risk driven by inconsistent daily medication use. This page focuses on aripiprazole lauroxil; the oral parent drug (with broader indications) is summarized on the aripiprazole overview. The LAI hub provides interval and overlap logistics across depots: LAI Navigator.

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  • Aripiprazole-class partial agonists often have lower sedation and prolactin burden than many SGAs, but activation symptoms (insomnia, anxiety) and Akathisia can be limiting. Because depot washout is slow, tolerability planning usually emphasizes early identification of adverse effects.
  • The compare view provides a risk snapshot across common depot options; the evidence feed can help track newer comparative studies.
  • Schizophrenia (adults): long-acting maintenance formulation.

Dosing & Formulations

Dosing interval depends on strength (monthly, every 6 weeks, or every 2 months in labeled schedules). Injection site (deltoid vs gluteal) can vary by dose and product instructions. Initiation requires bridging: either a multi-week oral aripiprazole overlap or a one-day initiation strategy using Aristada Initio per label. Clinics often standardize initiation checklists to reduce missed-step errors.

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  • Missed-dose management is interval-specific; the need to re-start oral supplementation or adjust injection timing depends on the time since the last injection and the prior maintenance schedule.
  • Switching from oral aripiprazole generally uses the established effective oral dose to choose a depot strength/interval. Switching from another antipsychotic is individualized to relapse risk and prior tolerability.

Monitoring & Risks

Boxed warning: increased mortality in elderly patients with dementia-related psychosis (antipsychotic class warning). Common tolerability limits include Akathisia/restlessness, insomnia or anxiety, nausea, and injection-site discomfort. Because depot concentrations change slowly, improvement or worsening after a dose change can be delayed.

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  • Metabolic monitoring remains standard even when weight gain risk is lower than with high-metabolic SGAs; follow routine monitoring of weight/BMI, lipids, and glucose/HbA1c.
  • Class risks still apply: NMS, tardive dyskinesia, orthostatic hypotension, leukopenia/neutropenia, and seizures are uncommon but clinically important in high-risk patients.
  • Impulse-control problems are uncommon but are a distinctive counseling point for aripiprazole-class partial agonists.

Drug Interactions

Exposure is sensitive to CYP2D6 and CYP3A4 inhibitors/inducers. Strong inhibitors can raise aripiprazole exposure and may require dose adjustment; strong inducers can substantially lower exposure and are generally avoided with depot formulations. Additive psychomotor impairment can occur with alcohol, benzodiazepines, opioids, or sedative hypnotics; monitor for falls and daytime somnolence.

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  • Combined dopamine-blocking agents can increase EPS risk; movement disorder monitoring is often used when combinations are unavoidable.

Practice Notes

Initiation logistics are the practical bottleneck: confirm oral tolerability, choose a bridging strategy, schedule follow-up, and document the missed-dose plan at the start. Longer dosing intervals can reduce visit burden, but they also extend the time to fully adjust if adverse effects or underdosing emerge; treatment teams often weigh interval convenience against clinical “steerability.”.

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Long-acting injectable (LAI) options

  • Aripiprazole lauroxil (Aristada/Aristada Initio)
    Interval
    q4–8wk (varies by strength)
    Oral overlap
    Yes — typically 21 days (unless using Initio loading)
    Injection site
    Deltoid or gluteal
    Notes
    • Initio option available for loading; see label

References

  1. ARISTADA prescribing information (DailyMed, 2025). — DailyMed (2025)
  2. Aristada Initio (aripiprazole Lauroxil) Extended Release Injectable Suspension — Prescribing Information — DailyMed (2025)
  3. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia — American Psychiatric Association (2020)
  4. Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017 — Pharmacopsychiatry (2018)
Aripiprazole lauroxil (ARISTADA, ARISTADA INITIO) — Summary — PsychMed