What is the best approach to managing a patient with chronic insomnia?

Approach to the Patient with Chronic Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be offered as first-line treatment to all adults with chronic insomnia before considering any pharmacological intervention. This represents a strong recommendation from the American College of Physicians, American Academy of Sleep Medicine, and VA/DoD guidelines, based on moderate-quality evidence demonstrating superior long-term efficacy compared to medications, with sustained benefits and no risk of tolerance or adverse effects 1, 2.

Initial Assessment and Diagnosis

Before initiating treatment, evaluate for:

• Sleep pattern specifics: Difficulty with sleep onset (taking >30 minutes to fall asleep), sleep maintenance (waking during the night with difficulty returning to sleep), or early morning awakening 1
• Duration and frequency: Symptoms occurring ≥3 nights per week for ≥3 months 1
• Daytime consequences: Fatigue, cognitive impairment, mood disturbance, or functional impairment 1
• Comorbid conditions requiring evaluation: Obstructive sleep apnea (snoring, witnessed apneas, gasping), restless legs syndrome (uncomfortable leg sensations with urge to move), circadian rhythm disorders (delayed or advanced sleep phase), psychiatric disorders (depression, anxiety, PTSD), and medical conditions (chronic pain, GERD, cardiovascular disease) 1

Critical pitfall: If insomnia fails to remit after 7-10 days of treatment, this indicates an underlying primary psychiatric or medical illness requiring further evaluation 3.

First-Line Treatment: Cognitive Behavioral Therapy for Insomnia

Core Components That Must Be Included

CBT-I is a multicomponent intervention delivered over 4-8 sessions that must include at least three of the following elements 1, 2:

• Sleep restriction therapy: Initially limit time in bed to match actual total sleep time (minimum 5 hours), then adjust weekly based on sleep efficiency (time asleep/time in bed × 100%). If sleep efficiency >85-90%, increase time in bed by 15-20 minutes; if <80%, decrease by 15-20 minutes 1, 2

• Stimulus control therapy: Go to bed only when sleepy; use bed only for sleep and sex; if unable to sleep within approximately 20 minutes, leave the bedroom and engage in quiet activity until drowsy, then return to bed; maintain consistent wake time regardless of sleep duration; avoid daytime napping 1, 2

• Cognitive therapy: Identify and restructure maladaptive beliefs about sleep, such as "I can't sleep without medication," "My life will be ruined if I can't sleep," or "I need 8 hours of sleep to function" 1, 2

• Relaxation training: Progressive muscle relaxation, diaphragmatic breathing, or guided imagery to reduce physiological and cognitive arousal 1

• Sleep hygiene education: Avoid caffeine after noon, evening alcohol, nicotine, late evening exercise (>3 hours before bed), excessive fluids before bed; optimize sleep environment (dark, quiet, cool); maintain regular sleep-wake schedule 1, 2

Delivery Methods

CBT-I can be effectively delivered through multiple formats 1, 2:

• Individual face-to-face therapy (most effective, with incremental odds ratio of 1.83) 2
• Group therapy sessions 1
• Telephone-based programs 1
• Internet-based self-directed modules 1
• Self-help books 1

Brief Behavioral Therapy for Insomnia (BBT-I) is an abbreviated 1-4 session version focusing on behavioral components (sleep restriction, stimulus control, sleep hygiene) that may be appropriate when resources are limited, though CBT-I has more robust evidence 1, 2.

Expected Outcomes and Timeline

Moderate-quality evidence demonstrates that CBT-I produces 1, 4:

• Reduced sleep onset latency by 19 minutes 4
• Reduced wake after sleep onset by 26 minutes 4
• Improved sleep efficiency by 9.91% 4
• Increased remission rates (36% vs 16.9% in controls) 5
• Benefits sustained at long-term follow-up with continued improvement beyond treatment end 2, 6

Important consideration: Improvements are gradual, with initial mild sleepiness and fatigue that typically resolve quickly 7. Sleep restriction may cause temporary daytime sleepiness but strengthens homeostatic sleep drive 2.

Contraindications and Precautions

Sleep restriction therapy should be used with caution or avoided in 2, 7:

• Patients with seizure disorders (sleep deprivation may lower seizure threshold) 7
• Bipolar disorder (sleep deprivation may trigger manic episodes) 7
• High-risk occupations requiring alertness (commercial drivers, heavy machinery operators) 2

Second-Line Treatment: Pharmacotherapy

Medications should only be considered after CBT-I has been attempted or when CBT-I alone is insufficient, using shared decision-making that includes discussion of benefits, harms, and costs. This represents a weak recommendation based on low-quality evidence 1.

Medication Selection Algorithm

For sleep onset insomnia 1, 7:

• First-line: Ramelteon 8 mg (melatonin receptor agonist with no abuse potential, safe for long-term use) 7, 3
• Alternatives: Zaleplon 10 mg (ultra-short-acting, can be taken mid-night if ≥4 hours remain before awakening), zolpidem 5-10 mg (5 mg maximum in elderly), triazolam 0.25 mg 7

For sleep maintenance insomnia 1, 7:

• First-line: Low-dose doxepin 3-6 mg (highly selective H1 antagonist, reduces wake after sleep onset by 22-23 minutes) 1, 8
• Alternatives: Suvorexant 10-20 mg (orexin receptor antagonist, reduces wake after sleep onset by 16-28 minutes), eszopiclone 2-3 mg, zolpidem 10 mg (5 mg in elderly), temazepam 15 mg 1, 7

For combined sleep onset and maintenance insomnia 7:

• Eszopiclone 2-3 mg (approved for long-term use) 7
• Zolpidem 10 mg (5 mg in elderly) 7

For patients with comorbid depression/anxiety 7:

• Sedating antidepressants are preferred as they simultaneously address mood disorder and sleep disturbance 7

Critical Safety Considerations

All hypnotic medications carry risks including 1, 8, 7:

• Daytime impairment and residual sedation 1
• Complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating) with amnesia 3
• Falls and fractures (particularly in elderly) 1, 8
• Cognitive impairment 1
• Rare but serious: angioedema, anaphylaxis (requiring emergency treatment) 3

Observational studies have shown associations with dementia, serious injury, and fractures with chronic hypnotic use 1.

Special considerations for elderly patients (≥65 years) 8, 7:

• Use lowest effective doses (e.g., zolpidem maximum 5 mg) 8
• Higher risk of falls, cognitive impairment, and complex sleep behaviors 8
• Increased sensitivity to medications requiring dose adjustment 8

Medications to Avoid

The following should NOT be used for chronic insomnia 1, 8, 7:

• Over-the-counter antihistamines (diphenhydramine, doxylamine): Lack efficacy data, cause daytime sedation, anticholinergic effects, and delirium risk especially in elderly 1, 8, 7

• Melatonin: Insufficient evidence for chronic insomnia treatment (only 7-minute decrease in sleep latency, 8-minute increase in total sleep time of unclear clinical significance) 1

• Trazodone: Explicitly not recommended due to insufficient efficacy data despite widespread use 8, 7

• Herbal supplements (valerian, chamomile): Insufficient evidence of efficacy 7

• Antipsychotics: Should not be used as first-line treatment due to problematic metabolic side effects 8

• Long-acting benzodiazepines (flurazepam): Increased risks without clear benefit, rarely prescribed due to extended half-life 1, 8

Prescribing Principles

When pharmacotherapy is necessary 8, 7:

• Use the lowest effective dose for the shortest duration possible (typically <4 weeks for acute insomnia) 8
• Prescribe for short-term use only due to concerns about tolerance, dependence, and adverse effects 8
• Always supplement with CBT-I—pharmacotherapy should never replace behavioral interventions 1, 7
• Reassess after 1-2 weeks to evaluate efficacy and monitor for adverse effects 7
• Conduct periodic reassessment if continuing long-term, with attempts at tapering 8
• Educate patients about treatment goals, realistic expectations, safety concerns (no alcohol, no driving after taking medication), and potential side effects 7

Common Pitfalls to Avoid

• Using sleep hygiene education alone as monotherapy: Sleep hygiene is insufficient as standalone treatment and may make patients less receptive to effective behavioral treatments; it should only serve as an adjunct to other CBT-I components 1, 2, 8

• Prescribing medications as first-line treatment: This undermines long-term outcomes, creates dependency risk, and diverts resources from more effective treatments 2

• Failing to implement CBT-I alongside medication: Behavioral interventions provide more sustained effects than medication alone and should be extended throughout any drug tapering 1, 7

• Combining multiple sedative medications: Significantly increases fall risk, cognitive impairment, and complex sleep behaviors 8

• Using doses appropriate for younger adults in elderly patients: Age-adjusted dosing is essential (e.g., zolpidem 5 mg maximum in those ≥65 years) 8, 7

• Continuing pharmacotherapy long-term without periodic reassessment: Regular monitoring is essential to evaluate ongoing need and consider tapering 8, 7

• Not evaluating for underlying sleep disorders: Insomnia persisting beyond 7-10 days of treatment requires assessment for sleep apnea, restless legs syndrome, or circadian rhythm disorders 7, 3

Monitoring and Follow-Up

• Collect sleep diary data before and during treatment to monitor progress and guide adjustments 2
• Follow-up regularly until insomnia stabilizes or resolves, then every 6 months 2
• Reassess for treatment response on sleep latency, sleep maintenance, daytime functioning, and adverse effects 7
• If insomnia fails to remit after 7-10 days, evaluate for primary psychiatric or medical illness 3

Special Populations

Patients with comorbid psychiatric conditions: CBT-I is effective for insomnia comorbid with depression, anxiety, and PTSD, with moderate to large improvements in sleep parameters and small to medium positive effects on comorbid symptoms (larger effects on psychiatric than medical conditions) 1, 5

Patients with comorbid medical conditions: CBT-I remains effective for insomnia comorbid with chronic pain and other medical conditions 1, 5

Patients with severe sleep apnea: Ramelteon has not been studied in this population and is not recommended 3

Patients with severe hepatic impairment: Ramelteon should not be used 3