What is the recommended treatment approach for insomnia, including non‑pharmacologic measures and pharmacologic options?

Treatment of Insomnia

Cognitive behavioral therapy for insomnia (CBT-I) should be the first-line treatment for all adults with chronic insomnia disorder, and pharmacologic therapy should only be added if CBT-I alone is unsuccessful. 1

Initial Treatment Approach

Start with CBT-I as monotherapy for chronic insomnia disorder (strong recommendation, moderate-quality evidence) 1. This recommendation applies to:

• All adult age groups, including older adults
• Patients with comorbid medical or psychiatric conditions
• Both sleep-onset and sleep-maintenance insomnia 2

What CBT-I Includes

CBT-I is a multicomponent intervention combining:

• Cognitive therapy addressing dysfunctional beliefs about sleep
• Behavioral interventions: sleep restriction therapy and stimulus control therapy
• Sleep hygiene education (though insufficient as monotherapy) 1

CBT-I Delivery Methods

Multiple delivery formats are effective 1:

• In-person individual therapy (most studied, generally considered optimal)
• Group therapy sessions
• Digital/internet-based programs
• Telephone-based modules
• Self-help books

Choose the delivery method based on availability, cost, and patient preference—all formats show efficacy. The key is ensuring patients receive the core components (sleep restriction, stimulus control, cognitive therapy) rather than focusing on a specific delivery modality 2.

When to Add Pharmacotherapy

Only consider adding medications after CBT-I has been tried and proven insufficient (weak recommendation, low-quality evidence) 1. Use shared decision-making to discuss:

• Benefits: improved sleep onset latency, total sleep time, and in some cases global outcomes
• Harms: daytime impairment, "sleep driving," behavioral abnormalities, worsening depression, and observational data linking hypnotics to dementia, serious injury, and fractures 1
• Duration: FDA approval is for short-term use (4-5 weeks); longer-term use lacks sufficient evidence 1

Evidence-Based Medication Options

For short-term use (≤4 weeks):

• Benzodiazepine receptor agonists (zolpidem, eszopiclone): Low-to-moderate quality evidence for improved sleep outcomes in general population and older adults 1
• Dual orexin receptor antagonists (suvorexant, daridorexant, lemborexant): Moderate-quality evidence for improved treatment response and sleep outcomes; can be used up to 3 months 1, 3
• Low-dose doxepin: Moderate-quality evidence for improved ISI scores and sleep outcomes in older adults 1

For patients ≥55 years:

• Prolonged-release melatonin: Can be used up to 3 months 3

Ramelteon: Low-quality evidence showed no statistically significant difference from placebo in the general population, though it decreased sleep onset latency in older adults 1

Medications NOT Recommended

• Antihistamines (diphenhydramine): Not adequately studied, not recommended 1, 3
• Trazodone: Not adequately studied despite common use 1
• Antipsychotics: Not recommended 3
• Fast-release melatonin: Not recommended 3
• Benzodiazepines: Widely used but insufficient evidence in the systematic review; associated with serious adverse effects 1

Critical Pitfalls to Avoid

1. Do not use sleep hygiene as monotherapy—it is minimally effective as a single intervention and may divert resources from more effective treatments 2

2. Do not combine CBT-I with medication from the start—recent evidence suggests against combination treatment over CBT-I alone (conditional recommendation against) 4. The exception: patients who highly value rapid improvement in total sleep time over reduction in daytime symptoms may reasonably choose combination therapy 4

3. Do not prescribe long-term pharmacotherapy without clear justification—evidence is insufficient for long-term use, and observational studies show serious harms including dementia and fractures 1

4. Use lower doses than studied, especially in older adults—FDA guidance suggests lower dosages than those used in many clinical trials 1

Treatment Algorithm

1. Diagnose chronic insomnia: Symptoms ≥3 nights/week for ≥3 months causing functional impairment 1

2. Initiate CBT-I monotherapy (any delivery format based on access and preference)

3. If CBT-I insufficient after adequate trial: Engage in shared decision-making about adding short-term pharmacotherapy (4-5 weeks)

4. Select medication based on:

   • Patient age (consider doxepin or prolonged-release melatonin for ≥55 years)
   • Primary symptom (sleep onset vs. maintenance)
   • Comorbidities and fall risk
   • Preference for shorter vs. potentially longer duration (orexin antagonists can extend to 3 months)

5. Reassess regularly and attempt medication discontinuation after short-term use