What are the guidelines for using Belsomra (suvorexant) in elderly patients?

Guidelines for Using Belsomra (Suvorexant) in Elderly Patients

Belsomra (suvorexant) should be used at a reduced dose of 15 mg in elderly patients (≥65 years) compared to the standard 20 mg dose used in non-elderly adults, with careful monitoring for adverse effects, particularly somnolence. 1

Efficacy and Dosing in Elderly Patients

Belsomra is an orexin receptor antagonist approved for treating insomnia. Clinical trials specifically evaluated its use in elderly populations:

• FDA-approved dosing for elderly patients (≥65 years) is 15 mg, compared to 20 mg for non-elderly adults 1
• In clinical trials, elderly patients (mean age 71 years) showed significant improvements in:
  • Sleep onset time
  • Total sleep time
  • Wake time after sleep onset 1
• Efficacy was demonstrated at both week 1 and maintained through month 3 of treatment 1, 2

Safety Considerations for Elderly Patients

Potential Adverse Effects

• Somnolence is the most common adverse effect (5.4% with 15 mg dose vs. 3.2% with placebo) 2
• FDA labeling warns about:
  • Cognitive and behavioral changes (amnesia, anxiety, hallucinations)
  • Complex behaviors such as sleep driving
  • Worsening depression or suicidal thinking in patients with depression
  • Daytime impairments
  • Sleep paralysis
  • Hypnagogic/hypnopompic hallucinations 3, 1

Special Precautions for Elderly

1. Fall Risk: Elderly patients are at higher risk for falls due to increased drowsiness 1
2. Cognitive Effects: Monitor for next-day impairment in cognition or driving ability 3
3. Medication Interactions: Elderly patients often take multiple medications, increasing risk of drug interactions 3, 4
4. Discontinuation: No strong signals for rebound or withdrawal were observed after 1-12 months of treatment 5, 6

Practical Recommendations for Use in Elderly

Initial Assessment

• Conduct comprehensive assessment of elderly patients for declining function 3
• Consider comorbidities, especially:
  • Respiratory conditions (COPD, sleep apnea)
  • Hepatic impairment (avoid in severe hepatic impairment)
  • Depression or psychiatric conditions 1

Dosing Algorithm

1. Starting dose: Begin with 15 mg in elderly patients (≥65 years) 1
2. Timing: Administer 30 minutes before bedtime
3. Dose adjustment: Lower doses (5-10 mg) may be considered for patients with:
   • Multiple comorbidities
   • Polypharmacy concerns
   • History of sensitivity to CNS medications 3
4. Duration: Efficacy has been demonstrated for up to 12 months of continuous use 6

Monitoring

• Assess for daytime somnolence and cognitive effects at follow-up visits
• Monitor for falls, especially in frail elderly
• Evaluate continued efficacy and need for treatment at regular intervals
• Discontinuation rate due to adverse effects is approximately 3.5% with the 15 mg dose 2

Comparison to Other Sleep Medications

The American Academy of Sleep Medicine clinical practice guidelines recommend several medications for treating insomnia in adults, including suvorexant 3. For elderly patients specifically:

• Suvorexant has a different mechanism of action (orexin receptor antagonism) compared to traditional hypnotics
• Lower risk of physical dependence compared to benzodiazepines
• May have fewer next-day effects than some benzodiazepines or Z-drugs
• Demonstrated efficacy specifically in elderly populations 2

Common Pitfalls to Avoid

1. Overdosing: Using the standard adult dose (20 mg) in elderly patients
2. Ignoring drug interactions: Particularly with other CNS depressants
3. Inadequate monitoring: Failing to assess for daytime impairment or falls
4. Prolonged use without reassessment: Continuing therapy without evaluating ongoing need
5. Abrupt discontinuation: Although studies show minimal withdrawal effects, gradual discontinuation may be preferable 6

By following these guidelines, clinicians can optimize the use of Belsomra in elderly patients while minimizing potential adverse effects and maximizing therapeutic benefit.