What is the recommended treatment approach for a patient presenting with insomnia?

Treatment of Insomnia

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

Initial Treatment Approach

All patients with insomnia must receive CBT-I as the foundation of treatment, regardless of whether medications are added later. 1, 2 This recommendation is based on superior long-term efficacy compared to medications, with sustained benefits after discontinuation and minimal adverse effects. 1, 2

Core Components of CBT-I

CBT-I combines multiple behavioral interventions that must be implemented together: 1

• Sleep restriction therapy: Limit time in bed to match actual sleep duration (e.g., if sleeping only 5 hours but spending 8 hours in bed, restrict bed time to 5.5 hours initially), then increase by 15-30 minutes weekly when sleep efficiency exceeds 85-90% 1

• Stimulus control therapy: Use bed only for sleep and sex; leave bedroom if unable to sleep within 15-20 minutes; maintain consistent wake time regardless of sleep obtained 1

• Cognitive restructuring: Address catastrophic thinking about sleep loss and dysfunctional beliefs about sleep requirements 1, 3

• Sleep hygiene education: Avoid caffeine after noon, eliminate evening alcohol, avoid late heavy meals, ensure bedroom is dark/quiet/cool, limit daytime napping to 30 minutes before 2 PM 1, 2

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

Critical Caveat for Sleep Restriction

Exercise caution with sleep restriction in patients with seizure disorder or bipolar disorder due to sleep deprivation effects. 2

Pharmacological Treatment Algorithm

Medications should supplement, not replace CBT-I, and are indicated only when behavioral interventions alone are insufficient. 1, 2

First-Line Pharmacotherapy Options

For sleep onset insomnia specifically:

• Zaleplon 10 mg (5 mg in elderly) 2
• Ramelteon 8 mg (melatonin receptor agonist with no dependence risk) 2, 4
• Zolpidem 10 mg (5 mg in elderly; addresses both onset and maintenance) 2, 5

For sleep maintenance insomnia specifically:

• Eszopiclone 2-3 mg (also effective for sleep onset) 2, 6
• Zolpidem 10 mg (5 mg in elderly) 2, 5
• Temazepam 15 mg 2

For both sleep onset AND maintenance:

• Eszopiclone 2-3 mg is the most versatile first-line option, showing 28-57 minute increase in total sleep time with moderate-to-large improvement in sleep quality 2

Second-Line Pharmacotherapy Options

If first-line agents fail or are contraindicated:

• Low-dose doxepin 3-6 mg for sleep maintenance (reduces wake after sleep onset by 22-23 minutes with minimal anticholinergic burden at this dose) 2
• Suvorexant (orexin receptor antagonist) for sleep maintenance (reduces wake after sleep onset by 16-28 minutes) 2

Third-Line Options for Comorbid Depression/Anxiety

Sedating antidepressants are appropriate when comorbid depression or anxiety is present:

• Mirtazapine 15-30 mg at bedtime (must be taken nightly, not PRN; requires several days to reach steady-state) 2, 3
• Trazodone at full antidepressant doses (150-300 mg), though the American Academy of Sleep Medicine explicitly recommends against trazodone for insomnia without depression 2, 3

Critical warning: Do NOT use low-dose sedating antidepressants (e.g., trazodone 50 mg, mirtazapine 7.5 mg) as monotherapy, as this undertreats depression. 3

Medications to Avoid

The following agents are explicitly NOT recommended:

• Over-the-counter antihistamines (diphenhydramine): Lack efficacy data, cause daytime sedation and delirium risk especially in elderly 2
• Herbal supplements (valerian) and melatonin: Insufficient evidence of efficacy 2
• Barbiturates and chloral hydrate: Outdated with unacceptable safety profiles 2
• Antipsychotics (quetiapine, olanzapine): Problematic metabolic side effects without evidence for insomnia 2
• Long-acting benzodiazepines (diazepam, clonazepam as first-line): Increased fall risk, cognitive impairment, and drug accumulation 2

Critical Safety Considerations

Complex Sleep Behaviors

All benzodiazepine receptor agonists (zolpidem, eszopiclone, zaleplon) carry FDA warnings about complex sleep behaviors including sleep-driving, sleep-walking, and sleep-eating. 6, 5 These can occur at therapeutic doses and may be life-threatening. Discontinue medication immediately if complex sleep behavior occurs. 6, 5

Next-Day Impairment

Risk of next-day psychomotor impairment increases with: 6, 5

• Less than 7-8 hours remaining for sleep after taking medication
• Doses higher than recommended
• Concomitant use with alcohol or other CNS depressants
• Elderly patients (who require lower doses)

Patients must be warned against driving or operating machinery the morning after use, especially with eszopiclone 3 mg. 6

Elderly-Specific Dosing

Mandatory dose reductions in patients ≥65 years: 2

• Zolpidem: Maximum 5 mg (not 10 mg)
• Eszopiclone: Start 1 mg, maximum 2 mg (not 3 mg)
• Zaleplon: 5 mg (not 10 mg)

Elderly patients have increased sensitivity, higher fall risk, and greater cognitive impairment with all hypnotics. 2

Duration of Treatment

The FDA indicates hypnotics are intended for short-term use. 2 Few studies evaluate medications beyond 4 weeks, and there is insufficient evidence to determine the balance of benefits and harms of long-term pharmacologic treatment. 2

If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) or psychiatric/medical conditions. 2, 5, 4

Monitoring Requirements

Reassess patients after 1-2 weeks to evaluate: 2

• Efficacy on sleep latency, sleep maintenance, and daytime functioning
• Adverse effects including morning sedation, cognitive impairment, complex sleep behaviors
• Need for ongoing treatment versus tapering

Implement periodic "drug holidays" to assess ongoing need when treatment extends beyond 2 weeks. 2

Common Pitfalls to Avoid

• Failing to implement CBT-I before or alongside medication (behavioral interventions provide more sustained effects than medication alone) 1, 2
• Using doses appropriate for younger adults in elderly patients (requires age-adjusted dosing) 2
• Prescribing multiple sedating agents simultaneously (increases fall risk, cognitive impairment, respiratory depression) 2, 3
• Continuing pharmacotherapy long-term without periodic reassessment 2
• Using sedating agents without considering specific effects on sleep onset versus maintenance 2
• Prescribing SSRIs/SNRIs for depression without addressing their sleep-disrupting effects 3

Special Populations

Patients with Comorbid Depression

Select an antidepressant with favorable sleep-promoting properties rather than adding a separate hypnotic: 3

• Mirtazapine 15-30 mg at bedtime (first-line for depression with insomnia)
• Trazodone 150-300 mg (full antidepressant dose, not low-dose for sleep only)

Always implement CBT-I alongside antidepressant therapy. 3

Patients with Substance Abuse History

Avoid benzodiazepines; consider ramelteon or suvorexant instead. 2

Patients with Hepatic Impairment

Zaleplon dose must be reduced to 5 mg in hepatic impairment (70-87% reduction in clearance). 2 Ramelteon is contraindicated in severe hepatic impairment. 4