Does Caplyta Cause Dry Mouth?
Yes, Caplyta (lumateperone) causes dry mouth as one of its most common side effects, occurring in 5-6% of patients taking the medication—significantly more than the 1-2% rate seen with placebo. 1
Evidence from FDA Drug Labeling
The FDA-approved prescribing information for Caplyta explicitly lists dry mouth as one of the most common adverse reactions across all approved indications:
In schizophrenia trials: Dry mouth occurred in 6% of Caplyta-treated patients versus 2% of placebo patients, making it one of the most common side effects (defined as ≥5% incidence and greater than twice the placebo rate). 1
In bipolar depression monotherapy trials: Dry mouth occurred in 5% of Caplyta patients versus 1% of placebo patients. 1
In bipolar depression adjunctive therapy trials: Dry mouth occurred in 5% of Caplyta patients versus 1% of placebo patients. 1
The FDA patient medication guide specifically lists dry mouth among "the most common side effects of CAPLYTA" alongside sleepiness, dizziness, and nausea. 1
Clinical Context and Mechanism
While Caplyta's mechanism for causing dry mouth is not explicitly anticholinergic (unlike many other psychotropic medications), the consistent reporting across multiple clinical trials establishes this as a genuine medication-related adverse effect. 1 This distinguishes it from strongly anticholinergic medications like tricyclic antidepressants or first-generation antipsychotics, where dry mouth rates are typically much higher. 2
Management Recommendations
If dry mouth occurs with Caplyta, the following stepwise approach is recommended:
First-line conservative measures:
- Optimize hydration by increasing water intake throughout the day and limiting caffeine consumption. 3, 4
- Use saliva substitutes such as moisture-preserving mouth rinses, sprays, or gels with neutral pH. 3, 4
- Employ salivary stimulants including sugar-free chewing gum, lozenges, or candy containing xylitol. 3, 4
- Implement dietary modifications by avoiding crunchy, spicy, acidic, or hot foods that may exacerbate discomfort. 3, 4
For persistent or severe cases:
- Consider systemic sialagogues such as pilocarpine (5 mg orally three to four times daily) or cevimeline for severe cases not responding to conservative measures. 3, 4
- Refer to dentistry for patients with moderate to severe dry mouth to ensure adequate oral hygiene and protect against dental caries, which is a significant risk with chronic xerostomia. 3
Important Clinical Caveats
- The relatively low incidence (5-6%) means most patients will not experience this side effect, and it should not automatically preclude Caplyta use when clinically indicated. 1
- Dry mouth from Caplyta is generally mild to moderate in severity, as evidenced by the fact that no single adverse reaction (including dry mouth) led to discontinuation in >2% of patients in clinical trials. 1
- Chronic dry mouth, if left unmanaged, increases risk for dental caries, periodontal disease, and oral infections—making proactive management important even for mild symptoms. 3, 5
- Polypharmacy can compound dry mouth risk, so review all medications the patient is taking for cumulative xerogenic effects. 5, 6