What is the incidence of Vraylar (cariprazine)-induced somnolence?

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Incidence of Vraylar (Cariprazine)-Induced Somnolence

Cariprazine causes somnolence in approximately 3-8% of patients, with rates varying by indication and dose, representing a low somnolence risk profile among antipsychotics. 1, 2, 3

Specific Incidence Rates by Indication

Schizophrenia

  • Somnolence occurred in 7% of cariprazine-treated patients versus 6% of placebo-treated patients in 6-week trials 1
  • In pooled analysis of eight Phase II/III studies (n=2048), somnolence was reported in 3.1% of patients receiving cariprazine 1.5-6 mg/day 3
  • Sedation occurred in 3.7% of patients in the same pooled analysis 3

Bipolar Mania

  • Somnolence was reported in 8% of cariprazine-treated patients compared to 4% of placebo-treated patients in 3-week trials 1

Bipolar Depression

  • In 6-week and 8-week trials, 7% of cariprazine-treated patients reported somnolence versus 4% in placebo-treated patients 1

Major Depressive Disorder (Adjunctive Treatment)

  • In 6-week trials, somnolence occurred in 6% of cariprazine-treated patients versus 4% of placebo-treated patients 1
  • In one 8-week trial, rates were higher at 11% for cariprazine versus 6% for placebo 1

Classification Among Antipsychotics

Cariprazine is classified as a "low somnolence" antipsychotic based on absolute risk increase (ARI) analysis across multiple psychiatric conditions 2. This places it in the same category as aripiprazole, asenapine, haloperidol, lurasidone, and paliperidone, distinguishing it from:

  • High somnolence agents: clozapine 2
  • Moderate somnolence agents: olanzapine, perphenazine, quetiapine, risperidone, ziprasidone 2

Clinical Characteristics of Somnolence

  • Most somnolence events were mild (71.0%) or moderate (26.5%) in severity 3
  • The FDA label warns that cariprazine may cause somnolence and has the potential to impair judgment, thinking, or motor skills 1
  • Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that cariprazine does not affect them adversely 1

Risk Factors and Management Considerations

Populations Requiring Vigilance

  • Complete fall risk assessments should be performed when initiating cariprazine in patients with diseases, conditions, or medications that could exacerbate somnolence, postural hypotension, or motor instability 1
  • Elderly patients may be at higher risk for falls and injuries related to somnolence 1

Dosing Considerations

  • The incidence of somnolence appears dose-related for some antipsychotics but not consistently demonstrated for cariprazine in the available data 2
  • Starting at lower doses with slower titration may help minimize somnolence risk 2

Concurrent Medications

  • Minimizing concurrent somnolence-prone agents is recommended to reduce additive sedative effects 2

Tolerance Development

Most cases of antipsychotic-induced somnolence are mild to moderate, and allowing tolerance to develop over at least 4 weeks is reasonable before considering discontinuation 2. This suggests that initial somnolence with cariprazine may improve with continued treatment.

References

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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