Does Vesicare (solifenacin) affect sleep?

Does Vesicare (Solifenacin) Affect Sleep?

Solifenacin can cause insomnia as an adverse effect, though this occurs infrequently and is primarily reported when compared to tolterodine rather than placebo. 1

Evidence for Sleep-Related Effects

Documented Insomnia Risk

• Insomnia was more frequently reported with oxybutynin than tolterodine in comparative trials, and this antimuscarinic class effect has been documented across multiple agents 1
• While solifenacin's FDA label does not specifically list insomnia as a common adverse reaction (>4%), the drug does cause central nervous system antimuscarinic effects including headache, confusion, hallucinations, and somnolence 2

Central Nervous System Considerations

• Solifenacin is a tertiary amine that crosses the blood-brain barrier, which explains its potential for CNS effects including sleep disturbances 3
• The FDA label explicitly warns about antimuscarinic CNS adverse reactions and recommends monitoring patients for these effects, particularly after initiating treatment or dose increases 2
• Patients experiencing CNS adverse reactions should be advised not to drive or operate heavy machinery until they understand how solifenacin affects them 2

Clinical Context

Comparison to Other Antimuscarinics

• The insomnia risk appears lower with solifenacin compared to oxybutynin, based on comparative safety data 1
• Among antimuscarinics, solifenacin 5 mg is associated with the lowest risk of treatment discontinuation, suggesting better overall tolerability 4

Dose-Related Considerations

• Most adverse effects with solifenacin are dose-dependent, with the 10 mg dose showing higher rates of anticholinergic effects than the 5 mg dose 2, 5
• If sleep disturbances occur, dose reduction from 10 mg to 5 mg should be considered before discontinuation 2, 5

Practical Recommendations

If a patient reports sleep disturbances on solifenacin:

• Consider whether the symptom began after starting the medication or increasing the dose 2
• Evaluate for other CNS antimuscarinic effects (confusion, somnolence, headache) that may indicate CNS sensitivity 2
• Reduce the dose to 5 mg if currently on 10 mg, as this may resolve the issue while maintaining efficacy 2, 5
• If insomnia persists on 5 mg, consider switching to mirabegron (a β3-adrenergic agonist with a different adverse effect profile and less anticholinergic CNS effects) 4

Important Caveat

While insomnia is documented with antimuscarinic agents as a class, it is not among the most common adverse effects of solifenacin (which are dry mouth, constipation, urinary tract infection, and blurred vision at higher doses) 2. The sleep disturbance risk should be weighed against the significant benefits in reducing overactive bladder symptoms 6, 7, 8.