What is the recommended treatment approach for insomnia in adults, including first‑line non‑pharmacologic and pharmacologic options?

Treatment for Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be initiated as the first-line treatment for all adults with chronic insomnia before any medication is prescribed. 1, 2, 3

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First-Line Treatment: CBT-I

• CBT-I provides superior long-term efficacy compared to pharmacotherapy, with sustained benefits persisting up to 2 years after treatment ends, whereas medication effects cease when stopped. 1, 2, 3, 4

• Core components that must be implemented include:

  • Stimulus control therapy – use the bed only for sleep; leave the bed if unable to fall asleep within ~20 minutes and return only when drowsy. 2, 5
  • Sleep restriction therapy – limit time in bed to approximate actual sleep time plus 30 minutes (minimum 5 hours), adjusting weekly based on sleep efficiency. 2, 5
  • Cognitive restructuring – systematically challenge maladaptive beliefs such as "I cannot sleep without medication." 2, 5
  • Relaxation techniques – progressive muscle relaxation, guided imagery, or controlled breathing to reduce physiological arousal. 2, 5
  • Sleep hygiene education – maintain consistent sleep-wake schedule, avoid caffeine ≥6 hours before bedtime, eliminate screens ≥1 hour before sleep, optimize bedroom environment (quiet, dark, cool). 2, 3

• Sleep hygiene education alone is insufficient as monotherapy and must be combined with stimulus control and sleep restriction to achieve sustained improvement. 2, 5

• CBT-I can be delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all formats demonstrate comparable effectiveness. 1, 2

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Pharmacologic Options (Only After CBT-I Initiation)

For Sleep-Onset Insomnia

• Zolpidem 10 mg (5 mg if age ≥65 years) shortens sleep-onset latency by ~25 minutes; take within 30 minutes of bedtime with ≥7 hours remaining before awakening. 2

• Zaleplon 10 mg (5 mg if age ≥65 years) has an ultrashort half-life (~1 hour), providing rapid sleep initiation with minimal next-day sedation; suitable for middle-of-night dosing when ≥4 hours remain. 2

• Ramelteon 8 mg is a melatonin-receptor agonist with no abuse potential, no DEA scheduling, and no withdrawal symptoms; appropriate for patients with substance-use history. 2

For Sleep-Maintenance Insomnia

• Low-dose doxepin 3–6 mg reduces wake after sleep onset by 22–23 minutes via selective H₁-histamine antagonism, with minimal anticholinergic effects and no abuse potential. 2

• Suvorexant 10 mg (orexin-receptor antagonist) reduces wake after sleep onset by 16–28 minutes and carries lower risk of cognitive and psychomotor impairment than benzodiazepine-type agents. 2

For Combined Sleep-Onset and Maintenance Insomnia

• Eszopiclone 2–3 mg (1 mg if age ≥65 years or hepatic impairment) increases total sleep time by 28–57 minutes and produces moderate-to-large improvements in subjective sleep quality. 2

• Take within 30 minutes of bedtime with at least 7 hours remaining before planned awakening. 2

• If 2 mg is tolerated but insufficient after 1–2 weeks, increase to 3 mg (maximum 2 mg for age ≥65 years). 2

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Medications Explicitly NOT Recommended

• Trazodone yields only ~10 minutes reduction in sleep latency with no improvement in subjective sleep quality; adverse events occur in ~75% of older adults. 2

• Over-the-counter antihistamines (diphenhydramine, doxylamine) lack efficacy data, cause strong anticholinergic effects (confusion, urinary retention, falls, daytime sedation, delirium), and develop tolerance within 3–4 days. 2, 3

• Traditional benzodiazepines (lorazepam, clonazepam, diazepam) have long half-lives leading to drug accumulation, prolonged daytime sedation, higher fall and cognitive-impairment risk, and associations with dementia and fractures. 2

• Antipsychotics (quetiapine, olanzapine) have weak evidence for benefit and significant risks including weight gain, metabolic dysregulation, extrapyramidal symptoms, and increased mortality in elderly with dementia. 2, 3

• Melatonin supplements produce only ~9 minutes reduction in sleep latency with insufficient supporting evidence. 2

• Herbal supplements (valerian, L-tryptophan) lack adequate evidence to support use for primary insomnia. 2

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Treatment Algorithm

1. Initiate CBT-I immediately for all patients with chronic insomnia, incorporating stimulus control, sleep restriction, relaxation, cognitive restructuring, and sleep-hygiene education. 1, 2, 3

2. Add first-line pharmacotherapy only if CBT-I alone is insufficient after 4–8 weeks:

   • Sleep-onset difficulty → zaleplon, ramelteon, or zolpidem (dose adjusted for age). 2
   • Sleep-maintenance difficulty → low-dose doxepin or suvorexant. 2
   • Combined difficulty → eszopiclone or zolpidem extended-release. 2

3. If the chosen first-line agent fails after 1–2 weeks, switch to an alternative agent within the same class (e.g., zaleplon → zolpidem for onset; doxepin → suvorexant for maintenance). 2

4. If multiple first-line agents are ineffective, consider sedating antidepressants (e.g., mirtazapine 7.5–30 mg), especially when comorbid depression or anxiety is present. 2

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Safety and Monitoring

• FDA labeling indicates hypnotics are intended for short-term use (≤4 weeks) for acute insomnia; evidence beyond 4 weeks is limited. 1, 2

• Reassess after 1–2 weeks to evaluate sleep-onset latency, total sleep time, nocturnal awakenings, daytime functioning, and adverse effects (somnolence, cognitive impairment, complex sleep behaviors). 2

• All benzodiazepine-receptor agonists carry FDA warnings for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating); discontinue immediately if these occur. 2

• Use the lowest effective dose for the shortest necessary duration; taper gradually when discontinuing to avoid rebound insomnia, using CBT-I to support cessation. 2

• For elderly patients (≥65 years), reduce maximum doses: zolpidem ≤5 mg, eszopiclone ≤2 mg, zaleplon ≤5 mg, doxepin ≤6 mg. 2

• Avoid alcohol while using these agents; it markedly increases risk of complex sleep behaviors and respiratory depression. 2

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Common Pitfalls to Avoid

• Initiating pharmacotherapy without first implementing CBT-I violates strong guideline recommendations and results in less durable benefit. 1, 2, 3

• Using adult dosing in older adults increases fall risk; age-adjusted dosing is mandatory. 2

• Combining multiple sedative agents markedly increases risk of respiratory depression, cognitive impairment, falls, and complex sleep behaviors. 2

• Continuing pharmacotherapy long-term without periodic reassessment (every 2–4 weeks) contradicts FDA labeling and guideline advice. 1, 2

• Prescribing agents without matching pharmacologic profile to insomnia phenotype (e.g., using zaleplon for maintenance rather than onset). 2

• Using trazodone, OTC antihistamines, antipsychotics, or traditional benzodiazepines despite lack of efficacy and significant safety concerns. 2, 3