Can Vraylar (cariprazine) cause insomnia?

Vraylar (Cariprazine) and Insomnia

Yes, Vraylar (cariprazine) can cause insomnia, with clinical trials showing insomnia rates of 7-10% in patients taking cariprazine compared to 4-7% in placebo groups. 1

Evidence of Insomnia as a Side Effect

The FDA drug label for cariprazine (Vraylar) clearly identifies insomnia as a common adverse reaction:

• In bipolar depression trials, insomnia occurred in 7-10% of cariprazine-treated patients compared to 7% in placebo groups 1
• In adjunctive therapy trials for major depressive disorder, insomnia was identified as one of the common adverse reactions (≥5% and at least twice the rate of placebo) 1
• In safety studies pooling data from eight Phase II/III clinical trials, insomnia was reported in 14.0% of cariprazine-treated patients, making it the second most common adverse event after akathisia (14.6%) 2

Clinical Significance and Management

Risk Factors and Presentation

• Insomnia with cariprazine appears to be dose-dependent, with higher rates at 3 mg doses compared to 1.5 mg doses 1
• The insomnia may present as initial insomnia, middle insomnia, or terminal insomnia 1
• Patients with pre-existing sleep disturbances may be at higher risk

Management Options

If insomnia occurs with cariprazine, consider these evidence-based approaches:

1. Dose adjustment:

   • Consider using the lowest effective dose of cariprazine
   • Morning administration may help reduce sleep disturbances

2. Sleep hygiene interventions 3:

   • Implement strict sleep hygiene, including consistent sleep-wake schedule
   • Limit daytime napping to 30 minutes maximum and not after 2pm
   • Regular morning or afternoon exercise
   • Limiting screen time before bed
   • Creating a calm, quiet, dark sleep environment

3. Adjunctive medications (if necessary):

   • For short-term management, consider melatonin as a safer option 3
   • In some cases, clinicians have reported using cariprazine with a benzodiazepine or another sedating agent for patients with agitation or insomnia 4
   • Avoid benzodiazepines in older patients and those with cognitive impairment due to risk of decreased cognitive performance 3

Comparative Context

Insomnia appears to be more common with cariprazine than with some other antipsychotics:

• Cariprazine causes more akathisia than aripiprazole or brexpiprazole but is less prone to sedation 5
• The insomnia profile of cariprazine differs from more sedating antipsychotics like quetiapine or olanzapine

Important Considerations

• Most adverse events with cariprazine, including insomnia, are considered mild (71.0%) or moderate (26.5%) 2
• Despite insomnia being common, it rarely leads to discontinuation of treatment 2
• The long half-life of cariprazine (7-8 days) means that side effects may persist for some time after dose adjustment or discontinuation 5
• When switching from other antipsychotics to cariprazine, a gradual cross-titration approach may help minimize sleep disturbances

Monitoring Recommendations

• Assess sleep quality at baseline and during follow-up visits
• Consider using standardized sleep assessment tools such as the Insomnia Severity Index or Pittsburgh Sleep Quality Index 3
• Follow up within 2-4 weeks of initiating cariprazine to assess for insomnia and other side effects 3

In conclusion, while insomnia is a recognized side effect of Vraylar, it can often be managed through proper dosing strategies, sleep hygiene interventions, and in some cases, adjunctive treatments. The benefits of cariprazine in treating the underlying condition should be weighed against the impact of insomnia on the patient's quality of life.