What are the best management strategies for a patient with insomnia, considering non-pharmacological and pharmacological interventions, including cognitive behavioral therapy for insomnia (CBT-I) and medications like melatonin, zolpidem, or eszopiclone?

Management of Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be the initial treatment for all adults with chronic insomnia before considering any pharmacological intervention. 1, 2, 3

First-Line Treatment: CBT-I

CBT-I is the gold standard with superior long-term efficacy compared to all pharmacological options, providing sustained benefits for up to 2 years after treatment completion. 2, 3 The American College of Physicians issues a strong recommendation (Grade: strong recommendation, moderate-quality evidence) that all adult patients receive CBT-I as initial treatment. 1

Core Components of Effective CBT-I

CBT-I must include at least three of the following evidence-based components: 3, 4

• Sleep Restriction Therapy: Limits time in bed to match actual sleep duration, creating mild sleep deprivation that strengthens homeostatic sleep drive and consolidates sleep. 3, 4 Initial restriction matches average sleep duration from sleep diary, then gradually adjusts based on sleep efficiency thresholds (typically ≥85% to increase, <80% to decrease). 3

• Stimulus Control Therapy: Strengthens the association between bed/bedroom and sleep by instructing patients to: go to bed only when sleepy, use bed only for sleep and sex, leave bedroom if unable to sleep within 15-20 minutes, and maintain consistent wake time. 3, 4

• Cognitive Therapy: Targets maladaptive beliefs about sleep using structured psychoeducation, Socratic questioning, thought records, and behavioral experiments to address Dysfunctional Beliefs and Attitudes About Sleep (DBAS). 3, 4

• Sleep Hygiene Education: Addresses environmental and behavioral factors including avoiding caffeine/nicotine before bed, limiting alcohol, maintaining comfortable sleep environment, and consistent sleep schedule—but is insufficient as monotherapy. 3, 5, 6

Treatment Delivery and Structure

• Standard format: 4-8 sessions with trained CBT-I specialist, using sleep diary data throughout to monitor progress and guide adjustments. 3, 4

• Alternative delivery methods are effective when in-person therapy is unavailable: individual or group therapy, telephone-based programs, web-based modules, or self-help books. 1, 3

• Brief Behavioral Therapy for Insomnia (BBT-I): Abbreviated 1-4 session version emphasizing behavioral components (sleep restriction, stimulus control) when resources are limited, though CBT-I has more robust evidence. 1, 3

Efficacy Data

Moderate-quality evidence demonstrates CBT-I produces clinically meaningful improvements: 1

• Reduced sleep onset latency by 19-30 minutes 1
• Decreased wake after sleep onset by 26-38 minutes 1
• Improved sleep efficiency to 85-90% 1, 3
• Enhanced subjective sleep quality with reduced ISI and PSQI scores 1
• Sustained benefits persist 6-24 months after treatment completion 2, 3

Critical Contraindications for Sleep Restriction

Sleep restriction may be contraindicated in: 3

• Patients working in high-risk occupations (commercial drivers, heavy machinery operators)
• Those predisposed to mania/hypomania
• Poorly controlled seizure disorders

Second-Line Treatment: Pharmacotherapy

Medications should only be considered when CBT-I alone is unsuccessful, unavailable, or as temporary adjunct—never as first-line monotherapy. 1, 2 The American College of Physicians recommends shared decision-making including discussion of benefits, harms, and costs before adding short-term pharmacotherapy. 1

First-Line Pharmacological Options

When medication is necessary after CBT-I failure: 1, 2, 5

For Sleep Onset and Maintenance Insomnia:

• Eszopiclone 2-3 mg: Most robust evidence for both sleep onset and maintenance, approved for long-term use, improves sleep latency by 10-15 minutes and total sleep time by 25-60 minutes. 1, 5, 7 However, carries higher risk of adverse events including unpleasant taste (15-30%), daytime drowsiness, and complex sleep behaviors. 8, 7

• Zolpidem 10 mg (5 mg in elderly/women): Effective for both sleep onset and maintenance with moderate-quality evidence, but FDA warns of complex sleep behaviors (sleep-driving, sleep-walking) and next-day impairment. 1, 5, 9 Maximum dose 5 mg in elderly due to increased fall risk and cognitive impairment. 1, 5

• Lemborexant 5-10 mg: Orexin receptor antagonist with favorable safety profile, lower risk of cognitive/psychomotor effects and complex sleep behaviors compared to benzodiazepines and Z-drugs. 2, 7 Demonstrates optimal balance between efficacy and tolerability at 5 mg starting dose. 2

For Sleep Onset Only:

• Zaleplon 10 mg (5 mg in elderly): Ultra-short-acting, can be taken middle-of-night if ≥4 hours remain before awakening. 2, 5

• Ramelteon 8 mg: Melatonin receptor agonist with no abuse potential, safe for long-term use, but low-quality evidence showed no statistically significant difference from placebo in general population. 1, 5

For Sleep Maintenance Only:

• Low-dose doxepin 3-6 mg: Highly selective H1 antagonist, reduces wake after sleep onset by 22-23 minutes with moderate-quality evidence, minimal anticholinergic burden at low doses. 1, 2, 5

• Suvorexant 10-20 mg: Orexin receptor antagonist with moderate-quality evidence for sleep maintenance, improved treatment response and reduced wake after sleep onset by 16-28 minutes. 1, 2, 5

Medications Explicitly NOT Recommended

The following should be avoided based on guideline recommendations: 1, 2, 5

• Trazodone: American Academy of Sleep Medicine explicitly recommends against use—insufficient efficacy data, modest improvements in sleep parameters but no improvement in subjective sleep quality, harms outweigh benefits. 1, 2, 5

• Over-the-counter antihistamines (diphenhydramine): Lack of efficacy data, daytime sedation, anticholinergic effects, delirium risk especially in elderly. 1, 2, 5

• Melatonin: Insufficient evidence in general population and older adults. 1, 2, 3

• Benzodiazepines (temazepam, triazolam, lorazepam, diazepam): Higher risk of tolerance, dependence, cognitive impairment, falls, fractures, and complex sleep behaviors compared to newer agents—insufficient evidence in systematic reviews. 1, 2, 5, 7

• Herbal supplements (valerian): Insufficient evidence of efficacy. 2, 5

• Antipsychotics: Should not be used as first-line treatment due to problematic metabolic side effects. 2, 5

Critical Safety Warnings for All Hypnotics

FDA black box warnings and safety concerns: 9, 8, 9

• Complex sleep behaviors: Sleep-driving, sleep-walking, eating, having sex, making phone calls while not fully awake—can result in serious injury or death. Discontinue medication immediately if occurs. 9

• Next-day impairment: Risk increased if taken with <7-8 hours sleep remaining, higher than recommended dose, or with alcohol/CNS depressants. 9

• Falls and fractures: Particularly in elderly patients due to drowsiness and decreased consciousness. 1

• Cognitive and behavioral changes: Driving impairment, memory impairment (anterograde amnesia), behavioral abnormalities, worsening depression. 1, 9

• Observational studies link hypnotics to: Dementia, serious injury, fractures (though primarily from benzodiazepine studies). 1

Medication Use Principles

Short-term use only (4-5 weeks maximum) is FDA-approved—insufficient evidence for long-term safety and efficacy. 1, 5 Key principles: 1, 2, 5

• Use lowest effective dose for shortest duration possible
• Always supplement with CBT-I, never replace it
• Take medication only when able to stay in bed 7-8 hours
• Do not take with or after meals (delays absorption)
• Reassess after 1-2 weeks for efficacy and adverse effects
• Taper when discontinuing to prevent rebound insomnia
• If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) 1, 5

Special Population: Elderly Patients (≥65 years)

Elderly require extra caution and dose adjustments: 1, 5

• Zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity
• Ramelteon 8 mg or low-dose doxepin 3 mg are safest choices—minimal fall risk and cognitive impairment
• Higher risk of falls, cognitive impairment, complex sleep behaviors, and daytime sedation
• More likely to report sleep maintenance problems than sleep onset problems

Treatment Algorithm

Step 1: Initial Assessment 1, 5

• Obtain 2-week sleep diary documenting sleep quality, parameters, napping, daytime impairment, medications, caffeine/alcohol use
• Assess for underlying causes: recent stressors, comorbid psychiatric/medical conditions, medication review
• Evaluate impact on quality of life, daytime functioning, driving ability, employment, relationships, mood
• Screen for other sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders)

Step 2: Initiate CBT-I 1, 2, 3

• Implement multicomponent CBT-I with trained specialist
• Deliver over 4-8 sessions (or abbreviated BBT-I if resources limited)
• Use sleep diary throughout to monitor progress
• Continue for full treatment course before declaring failure

Step 3: If CBT-I Insufficient 1, 2

• Continue CBT-I while adding pharmacotherapy (supplement, not replace)
• Use shared decision-making to select medication based on:
  • Primary complaint (sleep onset vs. maintenance vs. both)
  • Patient age (dose adjustments for elderly)
  • Comorbid conditions (depression/anxiety may favor sedating antidepressants)
  • History of substance abuse (avoid benzodiazepines, consider ramelteon or orexin antagonists)
  • Safety profile and patient preference

Step 4: Medication Trial 1, 2, 5

• Start lowest effective dose
• Reassess after 1-2 weeks for efficacy and adverse effects
• If ineffective, try alternative agent from same class before switching classes
• Maximum duration 4-5 weeks unless compelling reason for longer use
• Taper when discontinuing

Step 5: If First-Line Medication Fails 1, 2, 5

• Try alternative first-line agent
• Consider sedating antidepressants if comorbid depression/anxiety
• Refer to sleep medicine specialist if diagnosis uncertain or treatment challenging

Common Pitfalls to Avoid

• Using sleep hygiene education alone as treatment: Insufficient as monotherapy, may make patients less receptive to effective treatments like CBT-I. 1, 3, 6

• Prescribing medications as first-line without attempting CBT-I: Undermines long-term outcomes, creates dependency risk, violates guideline recommendations. 2, 3, 5

• Continuing pharmacotherapy long-term without periodic reassessment: No evidence for safety/efficacy beyond 4-5 weeks. 1, 5

• Using inappropriate doses in elderly: Zolpidem must be 5 mg maximum (not 10 mg) in patients ≥65 years. 1, 5

• Combining multiple sedatives: Significantly increases fall risk, cognitive impairment, and complex sleep behaviors. 1, 2

• Failing to screen for underlying sleep disorders: Sleep apnea, restless legs syndrome, circadian rhythm disorders require different treatment approaches. 1, 5

• Using benzodiazepines or trazodone: Not recommended based on current evidence—higher risks without clear benefits compared to alternatives. 1, 2, 5