Is Belsomra (suvorexant) safe in the elderly?

Safety of Belsomra (Suvorexant) in Elderly Patients

Belsomra (suvorexant) can be used safely in elderly patients, but should be initiated at a lower dose of 15 mg with careful monitoring for side effects, particularly daytime somnolence and fall risk.

Dosing and Administration for Elderly

• The FDA-approved starting dose for elderly patients (≥65 years) is 15 mg, taken 30 minutes before bedtime 1
• Lower doses (5-10 mg) may be considered for frail elderly patients or those with multiple comorbidities 2
• The maximum recommended dose for elderly patients is 15 mg, as higher doses increase risk of adverse effects 1, 3

Efficacy in Elderly Population

• Clinical trials specifically evaluating suvorexant in elderly patients (≥65 years) demonstrated effectiveness for:
  • Improving sleep maintenance
  • Reducing time to sleep onset
  • Enhancing sleep efficiency 3
• In pooled analyses of Phase III trials, suvorexant 15 mg showed efficacy in elderly patients with insomnia, though the onset effect was less evident at later time points 3

Safety Considerations and Adverse Effects

Common Adverse Effects

• Somnolence is the most common adverse effect, occurring in 5.4% of elderly patients taking 15 mg compared to 3.2% with placebo 2, 3
• The discontinuation rate due to adverse effects was 3.5% with the 15 mg dose over 3 months 2, 3

Important Warnings

1. CNS Depression and Fall Risk: Belsomra can cause daytime impairment and increase fall risk, which is particularly concerning in elderly patients 1
2. Cognitive Effects: May cause next-day impairment of driving and other activities requiring mental alertness 1
3. Complex Sleep Behaviors: Sleep-walking, sleep-driving, and engaging in other activities while not fully awake have been reported 1
4. Sleep Paralysis and Hallucinations: Hypnagogic/hypnopompic hallucinations and sleep paralysis can occur 1

Special Considerations for Elderly Patients

Polypharmacy Concerns

• Elderly patients are more likely to be on multiple medications that might interact with Belsomra 4
• Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases risk of CNS depression and requires dosage adjustments 1

Respiratory Function

• Use with caution in elderly patients with compromised respiratory function
• Belsomra has not been studied in patients with severe obstructive sleep apnea (OSA) or severe COPD 1

Hepatic Impairment

• No dose adjustment required for mild to moderate hepatic impairment
• Not recommended for patients with severe hepatic impairment 1

Monitoring Recommendations

• Assess for daytime somnolence, which may increase fall risk
• Monitor for cognitive impairment, particularly when initiating therapy
• Evaluate for complex sleep behaviors
• Consider discontinuing if a patient experiences a complex sleep behavior 1

Advantages Over Other Hypnotics

• Suvorexant has a unique mechanism of action as an orexin receptor antagonist, which may offer advantages over traditional hypnotics 2
• Lower risk of physical dependence compared to some other sleep medications 2
• Minimal withdrawal effects observed after gradual discontinuation 2, 5

Clinical Approach to Prescribing Belsomra in Elderly

1. Start with 15 mg dose in patients ≥65 years
2. Consider lower doses (5-10 mg) in frail elderly or those with multiple comorbidities
3. Monitor for daytime somnolence and fall risk
4. Avoid combining with other CNS depressants when possible
5. Counsel patients about potential next-day impairment and complex sleep behaviors

Belsomra represents a useful option for treating insomnia in elderly patients when used at appropriate doses with careful monitoring for adverse effects.