What are the first‑line non‑pharmacologic and pharmacologic treatments for insomnia in adults, including recommended medications, dosing, duration, and special considerations for patients aged 65 years and older?

First-Line Treatment for Insomnia in Adults

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the mandatory first-line treatment for all adults with chronic insomnia, and pharmacotherapy should only be added if CBT-I alone is insufficient after 4–8 weeks. 1, 2

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Non-Pharmacologic Treatment (Primary Intervention)

Core CBT-I Components

• Stimulus control therapy – Use the bed 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 daily (including weekends); eliminate daytime napping. 1, 3

• Sleep restriction therapy – Calculate mean total sleep time from a 1–2 week sleep diary, then prescribe time-in-bed to match that duration (minimum 5 hours); adjust weekly by 15–20 minutes based on sleep efficiency (increase if >85–90%, decrease if <80%). 1, 3

• Cognitive restructuring – Address maladaptive beliefs about sleep consequences, unrealistic sleep expectations, and anxiety about insomnia through structured cognitive therapy. 1, 4

• Relaxation techniques – Progressive muscle relaxation, guided imagery, or diaphragmatic breathing to reduce physiological and mental hyperarousal at bedtime. 1, 3

• Sleep hygiene education – Avoid caffeine ≥6 hours before bedtime, eliminate evening alcohol and nicotine, avoid vigorous exercise within 2 hours of sleep, keep bedroom cool/dark/quiet, limit evening fluids; this is insufficient as monotherapy and must be combined with other CBT-I components. 1, 2

CBT-I Delivery and Efficacy

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

• CBT-I provides superior long-term outcomes compared to medication alone, with sustained benefits for up to 2 years after treatment ends, whereas medication effects cease upon discontinuation. 1, 2, 5

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

First-Line Medications

For Sleep-Onset Insomnia

• Zolpidem 10 mg (5 mg for adults ≥65 years) – Reduces 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. 1

• Zaleplon 10 mg (5 mg for adults ≥65 years) – Ultra-short half-life (~1 hour) for rapid sleep initiation with minimal next-day sedation; can be taken middle-of-night if ≥4 hours remain before awakening. 1

• Ramelteon 8 mg – Melatonin-receptor agonist with no abuse potential, no DEA scheduling, no withdrawal symptoms; appropriate for patients with substance-use history. 1, 6

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 maintenance insomnia. 1

• Suvorexant 10 mg – Orexin-receptor antagonist reducing wake after sleep onset by 16–28 minutes; lower risk of cognitive/psychomotor impairment than benzodiazepine-type agents. 1

For Combined Sleep-Onset and Maintenance Insomnia

• Eszopiclone 2–3 mg (1 mg for adults ≥65 years or hepatic impairment) – Increases total sleep time by 28–57 minutes; moderate-to-large improvement in subjective sleep quality; take within 30 minutes of bedtime with ≥7 hours remaining. 1

• Zolpidem extended-release 10 mg (5 mg for adults ≥65 years) – Maintains therapeutic concentrations for >6 hours to support sleep continuity throughout the night. 1

• Temazepam 15 mg – Benzodiazepine-receptor agonist for both onset and maintenance, though carries higher risk profile than non-benzodiazepine alternatives. 1

Treatment Algorithm

1. Initiate CBT-I immediately for all patients with chronic insomnia. 1, 2

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

   • Sleep-onset difficulty → zaleplon, ramelteon, or zolpidem (age-adjusted dose)
   • Sleep-maintenance difficulty → low-dose doxepin or suvorexant
   • Combined difficulty → eszopiclone or zolpidem extended-release 1

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). 1

4. If multiple first-line agents are ineffective, consider sedating antidepressants (mirtazapine, low-dose doxepin >6 mg), especially when comorbid depression or anxiety is present. 1

Duration and Monitoring

• FDA labeling recommends hypnotics for short-term use (≤4 weeks) for acute insomnia; evidence does not support routine use beyond this period. 1

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

• Use the lowest effective dose for the shortest necessary duration; prescribe periodic "drug holidays" to assess ongoing need; taper gradually to avoid rebound insomnia. 1

• Pharmacotherapy should supplement—not replace—CBT-I, as behavioral interventions provide more sustained effects than medication alone. 1, 2

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Special Considerations for Adults ≥65 Years

Mandatory Dose Reductions

• Zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity and fall risk. 1, 3

• Eszopiclone maximum 2 mg (start at 1 mg) due to reduced drug clearance and heightened sensitivity. 1, 3

• Zaleplon maximum 5 mg (not 10 mg) to mitigate fall and cognitive impairment risk. 1

Preferred Agents for Older Adults

• Low-dose doxepin 3 mg and ramelteon 8 mg are the safest first-line options for adults ≥65 years due to minimal fall risk, no cognitive impairment, and no abuse potential. 1, 3

• Avoid benzodiazepines (lorazepam, clonazepam, diazepam) due to long half-lives causing drug accumulation, prolonged daytime sedation, higher fall/cognitive-impairment risk, and associations with dementia and fractures. 1, 3

Additional Safety Monitoring in Older Adults

• Screen for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating) at every visit; discontinue medication immediately if identified. 1

• Evaluate for underlying sleep disorders (sleep apnea, restless-legs syndrome, periodic limb movement disorder, circadian-rhythm disorders) if insomnia persists beyond 7–10 days despite treatment. 1

• Review all medications for insomnia-inducing agents: β-blockers, bronchodilators, corticosteroids, decongestants, diuretics, SSRIs, SNRIs. 3

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Medications Explicitly NOT Recommended

• 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. 1

• 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. 1, 3

• Traditional benzodiazepines (lorazepam, clonazepam, diazepam) – Long half-lives lead to drug accumulation, prolonged daytime sedation, higher fall/cognitive-impairment risk, associations with dementia and fractures. 1, 3

• Antipsychotics (quetiapine, olanzapine) – Weak evidence for insomnia benefit; significant risks (weight gain, metabolic dysregulation, extrapyramidal symptoms, increased mortality in elderly with dementia). 1, 2

• Melatonin supplements – Produce only ~9 minutes reduction in sleep latency; insufficient evidence of efficacy. 1

• Herbal supplements (valerian, L-tryptophan) – Insufficient evidence to support use for primary insomnia. 1, 7

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Critical Safety Warnings

• All benzodiazepine-receptor agonists carry FDA warnings for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating); patients must be counseled about these potentially life-threatening risks and instructed to discontinue immediately if they occur. 1

• Alcohol must be avoided while using hypnotics, as it markedly increases risk of complex sleep behaviors and respiratory depression. 1

• Next-day impairment occurs with all hypnotics; patients often do not perceive the impairment, so driving or operating machinery should be avoided until fully awake. 1

• Falls, fractures, and cognitive decline are increased with all hypnotics, especially in adults ≥65 years. 1, 6

• Observational data suggest possible associations between hypnotic use and higher dementia risk, though causality remains unproven. 1, 6

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Common Pitfalls to Avoid

• Initiating pharmacotherapy without first implementing CBT-I – leads to less durable benefit and higher relapse rates. 1, 2

• Using adult dosing in older adults – age-adjusted dosing (e.g., zolpidem ≤5 mg, eszopiclone ≤2 mg) is essential to reduce fall risk. 1, 3

• Combining multiple sedative agents – markedly increases risk of respiratory depression, cognitive impairment, falls, and complex sleep behaviors. 1

• Failing to reassess pharmacotherapy regularly – efficacy, side effects, and continued need should be evaluated every 2–4 weeks. 1

• Prescribing hypnotics without matching the pharmacologic profile to the insomnia phenotype – use zaleplon for sleep-onset only, doxepin for sleep-maintenance only, and eszopiclone for combined symptoms. 1

• Continuing hypnotic therapy long-term without periodic reassessment – FDA labeling indicates short-term use; routine use beyond 4 weeks is not supported by evidence. 1

• Using agents that are explicitly not recommended (trazodone, OTC antihistamines, antipsychotics, traditional benzodiazepines) – they lack efficacy and carry significant safety concerns. 1, 3, 2