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aripiprazole monohydrate

Long-acting injectable antipsychoticLAI available

Brands: ABILIFY MAINTENA

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

  • What is aripiprazole monohydrate?

    Aripiprazole monohydrate (Abilify Maintena) is a monthly LAI formulation of aripiprazole used for schizophrenia and bipolar I maintenance. It is often considered when adherence challenges or frequent relapse make a scheduled injection visit preferable to daily pills.

  • What is ABILIFY MAINTENA?

    ABILIFY MAINTENA is a brand name for aripiprazole monohydrate.

  • What is ABILIFY MAINTENA (aripiprazole monohydrate) used for?

    Label indications include: Schizophrenia; maintenance treatment of bipolar I disorder.

  • What drug class is ABILIFY MAINTENA (aripiprazole monohydrate)?

    Long-acting injectable antipsychotic.

  • What is the mechanism of action of ABILIFY MAINTENA (aripiprazole monohydrate)?

    Long-acting injectable aripiprazole formulation (D2/D3 partial agonist with 5-HT1A partial agonism and 5-HT2A antagonism) intended for maintenance treatment when monthly dosing supports adherence and relapse prevention.

  • What strengths does ABILIFY MAINTENA (aripiprazole monohydrate) come in?

    Intramuscular injection (monthly): 300 mg, 400 mg (deltoid or gluteal).

  • Is ABILIFY MAINTENA (aripiprazole monohydrate) 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: ABILIFY MAINTENA
  • 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; maintenance treatment of bipolar I disorder.

View labelExact

Clinical Highlights

Aripiprazole monohydrate (Abilify Maintena) is a monthly LAI formulation of aripiprazole used for schizophrenia and bipolar I maintenance. It is often considered when adherence challenges or frequent relapse make a scheduled injection visit preferable to daily pills. This page focuses on the depot product; the oral parent medication (with broader indications) is summarized on the aripiprazole overview. The LAI hub provides a workflow-focused view of intervals and overlap logistics: LAI Navigator.

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  • Compared with many second-generation antipsychotics, aripiprazole tends to have lower sedation, weight gain, and prolactin burden, but Akathisia/restlessness and insomnia can be limiting. With depot formulations, the long “tail” can make adverse effects slower to resolve after a dose change.
  • The compare view provides a quick risk snapshot across common depot options; the evidence feed can help track newer comparative or real-world adherence studies.
  • Schizophrenia (adults): maintenance treatment via long-acting injection.
  • Bipolar I disorder: maintenance treatment (monotherapy).

Dosing & Formulations

Typical maintenance dosing is an intramuscular injection every 4 weeks. Common strengths are 300 mg and 400 mg, with deltoid or gluteal administration depending on dose and patient factors. Oral tolerability is usually established before depot initiation. Label initiation typically includes a short oral aripiprazole overlap after the first injection to maintain coverage while depot concentrations rise.

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  • Missed-dose management is formulation-specific: the need for oral re-initiation or modified injection timing depends on the time since the last dose. Many clinics standardize a “missed injection” checklist to reduce accidental undertreatment.
  • Switching from oral aripiprazole commonly uses the established effective oral dose to guide depot selection. Switching from another antipsychotic is individualized to relapse risk, prior response, injection readiness, and recent adverse effects.
  • Injection-site selection and documentation matter: rotating sites and recording deltoid vs gluteal dosing help reduce local reactions and support consistent absorption over time.

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 the depot continues to release medication between visits, symptom changes after a dose adjustment can lag behind the clinic encounter.

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  • Metabolic monitoring (weight/BMI, lipids, glucose/HbA1c) remains standard even when a medication is comparatively weight-neutral versus higher-risk agents (e.g., olanzapine).
  • Class risks still apply: NMS, tardive dyskinesia, orthostatic hypotension, leukopenia/neutropenia, and seizures are uncommon but clinically important in high-risk patients.
  • Impulse-control warnings (new urges to gamble, binge, shop, or hypersexuality) are uncommon but are a specific counseling point for aripiprazole-class partial agonists.

Drug Interactions

Aripiprazole exposure is sensitive to CYP2D6 and CYP3A4 inhibitors/inducers. Dose or interval modifications may be needed with strong inhibitors; strong inducers can substantially reduce exposure and are generally avoided with long-acting formulations. Additive sedation or psychomotor impairment can occur with alcohol, benzodiazepines, opioids, or sedative hypnotics; clinical monitoring focuses on falls, daytime somnolence, and functional status.

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  • Concomitant dopamine-blocking agents can increase EPS risk, while antihypertensives can compound orthostasis; these combinations are common in practice and usually managed with careful titration rather than strict avoidance.

Practice Notes

Depot success depends on system design: reliable reminders, same-day injection capability, and clear documentation of last injection date and site reduce missed doses and dosing errors. Because washout is slow, side-effect plans often emphasize early identification of akathisia and timely interventions (dose adjustment, adjunctive beta-blocker, or formulation change) rather than waiting for weeks of spontaneous resolution.

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  • Cross-setting transitions (inpatient to outpatient, jail/prison to community) can be safer when the next injection date and any oral overlap plan are explicitly handed off in discharge paperwork.
  • The print handout can support clinic workflows; the schizophrenia hub and bipolar disorder hub cover longitudinal relapse-prevention pathways.

Long-acting injectable (LAI) options

  • Aripiprazole monohydrate (Abilify Maintena)
    Interval
    Monthly (q4wk)
    Oral overlap
    Yes — typically 14 days
    Injection site
    Deltoid or gluteal
    Notes
    • Consider 2‑week oral overlap after first injection

References

  1. ABILIFY MAINTENA prescribing information (DailyMed, 2025). — DailyMed (2025)
  2. Safety OF Once Monthly Aripiprazole Initiation IN Schizophrenia — Current Medical Research and Opinion (2013)
  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 monohydrate (ABILIFY MAINTENA) — Summary — PsychMed