Managing acute agitation and aggression in the world of drug shortages

Miller, Jennifer

doi:10.9740/mhc.2021.11.334

Cited by 8 publications

(14 citation statements)

References 68 publications

(151 reference statements)

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“…Each component is scored from 1 (minimum) to 7 (maximum) and summed together to correlate to the severity of agitation: scores of 5-13 represents mild agitation, 14-19 represents moderate, and 20-35 represents severe. 13,22 Five doses of dexmedetomidine sublingual film (20, 60, 80, 120, 180 μg) were compared with placebo and study participants were randomized in a 2:1 ratio to receive each dose of study drug or matching placebo. Study drug was given as an initial dose of 20 μg followed by single doses of 60, 80, 120, and 180 μg, except for the 20 μg treatment arm.…”

Section: Clinical Trialsmentioning

confidence: 99%

“…Participants were required to meet standard inclusion criteria for agitation including a baseline total score on the PEC of ≥14 and a score ≥4 on at least one of the PEC items. 13…”

Section: Clinical Trialsmentioning

confidence: 99%

“…Expected behaviors seen moderate agitation would include excitement, hostility, poor impulse control, tension, and uncooperativeness. 13…”

Section: Clinical Trialsmentioning

confidence: 99%

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Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders

2023

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Objective: The objective of this study was to review the available literature for dexmedetomidine sublingual film use in the treatment of acute agitation associated with schizophrenia and bipolar disorders. Data Sources: A literature search of PubMed (January 2017-March 2023) and EMBASE (January 2017-March 2023) was performed using the terms: Igalmi, dexmedetomidine, schizophrenia, bipolar disorder, and agitation. Additional information sources include ClinicalTrials.gov, scientific posters, and articles identified through review of references from clinical trials publications. Study Selection and Data Extraction: Relevant English-language articles conducted in humans were considered, with a preference for phase 3 clinical trials. Trial analyses and articles discussing pharmacology, pharmacokinetics, efficacy, and safety were also evaluated. Data Synthesis: Dexmedetomidine sublingual film was evaluated for use in schizophrenia in the SERENITY 1 pivotal trial and for bipolar disorders in the SERENITY 2 pivotal trial. Both studies found treatment of mild to moderate agitation with dexmedetomidine sublingual film 180 and 120 μg to be superior to placebo in reducing the severity of agitation. Treatment effect was seen as early as 20 minutes. Somnolence was the most common adverse effect in both studies. Cardiovascular adverse effects were mild and transient in most cases. Relevance to Patient Care and Clinical Practice: Dexmedetomidine sublingual film is a new and novel treatment for agitation and gives clinicians an alternative to antipsychotic and benzodiazepine use. It has advantageous properties including its noninvasive route of administration, fast absorption, and rapid onset of effect. Cost may limit its use. Conclusion: Dexmedetomidine sublingual film provides an alternative approach to treatment of acute agitation in adults with schizophrenia and bipolar disorders based on both mechanism of action and route of administration.

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Section: Clinical Trialsmentioning

confidence: 99%

“…Participants were required to meet standard inclusion criteria for agitation including a baseline total score on the PEC of ≥14 and a score ≥4 on at least one of the PEC items. 13…”

Section: Clinical Trialsmentioning

confidence: 99%

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Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders

2023

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“…For acute agitation as a result of schizophrenia or bipolar disorder, oral antipsychotics and/or oral benzodiazepines are first line, followed by intramuscular antipsychotics and/or benzodiazepines [5][6][7][8][9][10]. With high prevalence of acute agitation in emergency care settings, combined with recent shortages of medications commonly used for agitation and concerns related to current therapies, there has been an increasing interest in new treatment options for acute agitation management [11,12].…”

Section: Introductionmentioning

confidence: 99%

Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

Smith

Santalucia

Bunn

et al. 2023

Clin Psychopharmacol Neurosci

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Acute agitation is common amongst individuals with bipolar disorder and schizophrenia and represents a medical emergency. Commonly used medications for agitation, such as benzodiazepines and antipsychotics, are often delivered intramuscularly and may cause adverse effects. Non-invasive, effective, and safe alternative treatment options are needed. The purpose of this review article is to describe the efficacy and safety of sublingual formulation of dexmedetomidine (Igalmi), a selective α2-adrenergic receptor agonist, U.S. Food and Drug Administration approved for the treatment of acute agitation in adults with schizophrenia or bipolar I and II disorder. In two phase 3 trials, two dose strengths of sublingual dexmedetomidine 180 μg and 120 μg were safe and effective in managing acute agitation in patients with bipolar disorder or schizophrenia. Both doses significantly reduced Positive and Negative Syndrome Scale-Exited Component scores two hours after receiving a single dose as compared to placebo, indicating a substantial improvement in agitation. The beneficial effects of sublingual dexmedetomidine were achieved without serious adverse events with the most common side effect being mild somnolence. The clinical trial data suggest that sublingual dexmedetomidine represents a safe and effective treatment option in the armamentarium for acute agitation for people with schizophrenia or bipolar disorder.

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“…If these treatment modalities are not effective, pharmacological treatment is then suggested. In the past, Haldol combined with a benzodiazepine administered intramuscularly was commonly used for the treatment of agitation (Miller, 2021). However, recent studies have suggested the use of ketamine as more effective in rapid sedation of patients with moderate to severe agitation in the ED.…”

mentioning

confidence: 99%

Is Ketamine an Effective Treatment of Acute Agitation in the Emergency Department? Implications for APRN Practice

Brown,

Evans,

Tucker

2023

Advanced Emergency Nursing Journal

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This article reviews the results of a randomized controlled trial, “Rapid Agitation Control with Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial” by D. Barbic et al. (2021), comparing time to sedation, level of sedation, and adverse outcomes between intramuscular ketamine versus intramuscular midazolam and haloperidol among acutely agitated patients presenting to the emergency department (ED). The findings are discussed in the context of practice change for patient stabilization within the ED. Emergency department nurse practitioners must employ continuing education and remain current with clinical practices and treatment options to ensure that patients receive optimal safe care. Although the use of midazolam and haloperidol has historically been the first-line treatment for the acutely agitated patient, use of ketamine shows promise in providing a safe alternative for expedited patient stabilization for acutely agitated patients presenting to the ED.

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Managing acute agitation and aggression in the world of drug shortages

Cited by 8 publications

References 68 publications

Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders

Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders

Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

Is Ketamine an Effective Treatment of Acute Agitation in the Emergency Department? Implications for APRN Practice

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