What are the recommended non‑pharmacologic and pharmacologic treatment options for insomnia in adults, including dosing considerations for patients aged 65 years or older?

Treatment of Insomnia in Adults

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for all adults with chronic insomnia and must be initiated before or alongside any pharmacotherapy. 1, 2

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Non-Pharmacologic Treatment (First-Line for All Patients)

Core CBT-I Components

• Stimulus control therapy – Use the bedroom only for sleep and sex; leave the bedroom if unable to fall asleep within ~20 minutes; return only when sleepy; maintain consistent sleep-wake times; avoid daytime napping. 2

• Sleep restriction/compression therapy – Limit time in bed to match actual sleep time (calculated from a 1–2 week sleep diary), maintaining sleep efficiency ≥85%; never set time in bed below 5 hours; adjust weekly by 15–20 minutes based on sleep efficiency. 2

• Relaxation techniques – Progressive muscle relaxation, guided imagery, and diaphragmatic breathing to achieve a calm state conducive to sleep onset. 2

• Cognitive restructuring – Address unrealistic sleep expectations and anxiety about sleep through structured cognitive therapy. 2

• Sleep hygiene modifications – Cool, dark, quiet bedroom; avoid caffeine after noon; avoid nicotine and alcohol in the evening; avoid vigorous exercise within 2 hours of bedtime; limit evening fluids; maintain stable bedtime and wake time. 2

CBT-I provides superior long-term efficacy compared to medications, with sustained benefits for up to 2 years after treatment ends. 2, 3 It can be delivered via individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all formats show effectiveness. 2, 4

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Pharmacologic Treatment (Second-Line, After CBT-I Initiation)

When to Consider Medication

Pharmacotherapy should only be added when CBT-I alone has been insufficient after 4–8 weeks, using shared decision-making that discusses benefits, harms, and costs of short-term medication use. 2 Medications should supplement—not replace—ongoing behavioral interventions. 2, 4

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First-Line Pharmacologic Agents

For Sleep-Onset Insomnia

• Zolpidem 10 mg (5 mg for adults ≥65 years) – Shortens sleep-onset latency by ~25 minutes and increases total sleep time by ~29 minutes; take within 30 minutes of bedtime with ≥7 hours remaining before awakening. 2, 4

• Zaleplon 10 mg (5 mg for adults ≥65 years) – Very short half-life (~1 hour); provides rapid sleep initiation with minimal next-day sedation; suitable for middle-of-night dosing when ≥4 hours remain before awakening. 2, 4

• Ramelteon 8 mg – Melatonin-receptor agonist with no abuse potential, no DEA scheduling, and no withdrawal symptoms; appropriate for patients with substance-use history. 2, 4

For Sleep-Maintenance Insomnia

• Low-dose doxepin 3–6 mg – Reduces wake after sleep onset by 22–23 minutes via selective H₁-histamine antagonism; minimal anticholinergic effects at hypnotic doses; no abuse potential; preferred first-line option for elderly patients (≥65 years). 2, 4, 3

• Suvorexant 10 mg – Orexin-receptor antagonist; reduces wake after sleep onset by 16–28 minutes; lower risk of cognitive and psychomotor impairment than benzodiazepine-type agents. 2, 4

For Combined Sleep-Onset and Maintenance Insomnia

• Eszopiclone 2–3 mg (1 mg for adults ≥65 years; maximum 2 mg for elderly) – Improves both sleep onset and maintenance; increases total sleep time by 28–57 minutes; moderate-to-large gains in perceived sleep quality. 2, 4

• Zolpidem extended-release 10 mg (6.25 mg for adults ≥65 years) – Maintains therapeutic concentrations for >6 hours, supporting sleep continuity throughout the night. 2

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Dosing Adjustments for Adults ≥65 Years

All hypnotic doses must be reduced in elderly patients due to increased sensitivity, reduced drug clearance, and higher risk of falls, cognitive impairment, and complex sleep behaviors. 2

• Zolpidem: maximum 5 mg 2
• Eszopiclone: start 1 mg, maximum 2 mg 2, 4
• Zaleplon: maximum 5 mg 2
• Doxepin: start 3 mg, maximum 6 mg 2, 3
• Suvorexant: start 10 mg 2

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Medications Explicitly NOT Recommended

Strong Recommendations Against

• Trazodone – Yields only ~10 minutes reduction in sleep latency and ~8 minutes reduction in wake after sleep onset; no improvement in subjective sleep quality; adverse events in ~75% of older adults (headache, somnolence); harms outweigh minimal benefits. 2, 4, 3

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

• Traditional benzodiazepines (lorazepam, clonazepam, diazepam, temazepam) – Long half-lives lead to drug accumulation and prolonged daytime sedation; higher risk of falls, cognitive impairment, respiratory depression, dependence, and associations with dementia and fractures; especially dangerous in elderly patients. 2, 4, 3

• Antipsychotics (quetiapine, olanzapine) – Weak evidence for insomnia benefit; significant risks including weight gain, metabolic dysregulation, extrapyramidal symptoms, and increased mortality in elderly patients with dementia. 2, 4

• Melatonin supplements – Produce only ~9 minutes reduction in sleep latency; insufficient evidence of efficacy. 2, 4

• Herbal supplements (valerian, L-tryptophan) – Insufficient evidence to support use for primary insomnia. 2, 4

• Barbiturates and chloral hydrate – Absolutely contraindicated due to unacceptable safety profile. 2, 4

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Treatment Duration and Safety Monitoring

Duration Guidelines

• FDA labeling recommends hypnotics for short-term use (≤4 weeks) for acute insomnia; evidence does not support routine use beyond this period. 2, 4

• Use the lowest effective dose for the shortest necessary duration. 2, 4

• Consider periodic "drug holidays" to assess ongoing need. 2

• Taper gradually when discontinuing to avoid rebound insomnia; CBT-I facilitates successful medication discontinuation. 2, 4

Monitoring Requirements

• Reassess after 1–2 weeks to evaluate effects on sleep-onset latency, total sleep time, nocturnal awakenings, and daytime functioning. 2, 4

• Monitor for adverse effects: morning sedation, cognitive impairment, falls, complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating). 2, 4

• Discontinue medication immediately if complex sleep behaviors occur. 2, 4

• If insomnia persists beyond 7–10 days despite treatment, evaluate for comorbid sleep disorders (sleep apnea, restless-legs syndrome, periodic limb movement disorder, circadian-rhythm disorders). 2, 4

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Stepwise 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. 2, 4

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

   • Sleep-onset difficulty → zaleplon, ramelteon, or zolpidem (age-adjusted dose) 2, 4
   • Sleep-maintenance difficulty → low-dose doxepin or suvorexant 2, 4, 3
   • Combined difficulty → eszopiclone or zolpidem extended-release 2, 4

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

4. If multiple first-line agents are ineffective, consider sedating antidepressants (low-dose mirtazapine 7.5–30 mg) or alternative orexin-receptor antagonists, especially when comorbid depression or anxiety is present. 2, 4

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Common Pitfalls to Avoid

• Initiating pharmacotherapy without first employing CBT-I – Behavioral interventions provide more durable benefits than medication alone. 2, 4

• Using adult dosing in older adults – Age-adjusted dosing is essential to reduce fall and cognitive-impairment risk. 2

• Combining multiple sedative agents – Markedly increases risk of respiratory depression, cognitive impairment, falls, and complex sleep behaviors. 2, 4

• Failing to reassess pharmacotherapy regularly – Evaluate efficacy, side effects, and plan tapering every 2–4 weeks. 2, 4

• Prescribing agents without matching their pharmacologic profile to the specific insomnia phenotype – Use zaleplon for onset only, doxepin for maintenance only, and eszopiclone for combined symptoms. 2, 4

• Using trazodone, OTC antihistamines, antipsychotics, or traditional benzodiazepines for primary insomnia – These lack efficacy and carry significant safety concerns. 2, 4, 3

• Overlooking medication-induced insomnia – β-blockers, bronchodilators, corticosteroids, decongestants, diuretics, SSRIs, and SNRIs frequently cause or worsen insomnia in elderly patients. 2