What are the new medication options available for insomnia?

New Medications for Insomnia Management

Suvorexant (Belsomra) is the newest FDA-approved medication for insomnia, representing a novel class of dual orexin receptor antagonists (DORAs) that effectively treats both sleep onset and maintenance insomnia. 1, 2

First-Line Treatment Approach

Before considering medication:

• Cognitive Behavioral Therapy for Insomnia (CBT-I) should be implemented for 4-8 weeks as first-line treatment
• CBT-I components include sleep restriction/consolidation, stimulus control, cognitive restructuring, sleep hygiene education, and relaxation techniques 1

Newer Medication Options

Dual Orexin Receptor Antagonists (DORAs)

• Suvorexant (Belsomra)
  • Mechanism: First-in-class dual antagonist of orexin receptors OX1R and OX2R
  • Dosage: 10-20mg (standard adult), lower doses for elderly (15mg)
  • Indication: Both sleep onset and maintenance insomnia 1, 2
  • Efficacy: Improves subjective total sleep time by approximately 22.7 minutes and reduces time to sleep onset by 9.5 minutes compared to placebo 3
  • Safety profile: Generally well-tolerated with somnolence (13%) as the most common side effect 4
  • Contraindications: Narcolepsy; use with caution in patients at risk for REM sleep behavior disorder, depression, or delirium 5

Other Recent Options

• Ramelteon (8mg)

  • Melatonin receptor agonist specifically for sleep onset insomnia 1
  • Lower risk profile than traditional hypnotics

• Low-dose Doxepin (3-6mg)

  • Indicated for sleep maintenance insomnia 1
  • Lower doses minimize anticholinergic side effects seen with higher doses

Medication Selection Algorithm

1. Determine insomnia type:

   • Sleep onset insomnia: Zaleplon (10mg), Ramelteon (8mg), or Zolpidem (10mg; 5mg for elderly)
   • Sleep maintenance insomnia: Doxepin (3-6mg), Eszopiclone (2-3mg), Temazepam (15mg)
   • Both onset and maintenance: Suvorexant (10-20mg) 1

2. Consider patient factors:

   • Elderly patients: Use lower doses (zolpidem 5mg, doxepin 3mg)
   • History of substance use: Prefer non-scheduled options (ramelteon, doxepin)
   • Respiratory conditions: Avoid sedating medications
   • Cognitive impairment/dementia: Avoid benzodiazepines and sedating medications 1

3. Alternative options:

   • Low-dose melatonin (1-3mg) 1-2 hours before bedtime as a safer alternative
   • Mirtazapine (7.5-15mg) for patients with comorbid depression and insomnia 1

Monitoring and Follow-up

• Reassess within 2-4 weeks after initiating treatment
• Monitor for side effects, particularly daytime sedation, falls, and cognitive changes
• Schedule regular medication reviews to assess continued need
• Consider periodic medication-free intervals 1

Important Caveats

• Long-term use of any sleep medication is generally not recommended
• Use the lowest effective dose for the shortest duration necessary
• Benzodiazepines should be avoided in elderly patients due to increased risk of falls, confusion, and dependence
• Antihistamines have limited efficacy data for long-term use and risk of anticholinergic side effects 1

While suvorexant has demonstrated efficacy in clinical trials lasting up to one year 4, it has not been directly compared to traditional sleep agents in head-to-head trials 6. A small open-label study suggests potential benefit in patients with psychiatric disorders 7, though larger studies are needed in this population.