Last reviewed 2026-04-20 · How we verify

Adasuve (LOXAPINE)

Adasuve (loxapine) is a small molecule drug class loxapine that targets the 5-hydroxytryptamine receptor 2A. Originally developed and currently owned by Nova Pneuma, it was FDA approved in 1975 for the treatment of bipolar disorder and schizophrenia. Adasuve is a patented medication with no generic manufacturers available. Key safety considerations include its potential for respiratory depression and other serious side effects. It has a bioavailability of 30%.

At a glance

Approved indications

• Bipolar disorder
• Schizophrenia

Boxed warnings

• WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).

Common side effects

• Drowsiness
• Sedation
• Dizziness
• Faintness
• Staggering gait
• Shuffling gait
• Muscle twitching
• Weakness
• Insomnia
• Agitation
• Tension
• Seizures

Drug interactions

• cabergoline
• entacapone
• levodopa
• pergolide
• pramipexole
• ropinirole

Key clinical trials

• Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
• A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
• Staccato Prochlorperazine Single Dose PK Study (PHASE1)
• Outcomes of Antipsychotic Medication Used in the Emergency Department
• AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine (PHASE3)
• Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg (PHASE1)
• A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders
• Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain (PHASE2)

Patents

Primary sources

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