What are the recommended treatment options for a patient presenting with insomnia, considering their medical history and potential underlying mental health conditions?

Treatment of Insomnia

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

First-Line Treatment: CBT-I

• The American Academy of Sleep Medicine and American College of Physicians provide a STRONG recommendation that all patients with chronic insomnia receive CBT-I as initial treatment, based on moderate-quality evidence from 49 randomized controlled trials demonstrating clinically meaningful improvements in remission rates, sleep quality, sleep latency, and wake after sleep onset. 1, 2

• CBT-I produces sustained benefits lasting up to 2 years, unlike pharmacotherapy which shows degradation of benefit after discontinuation. 2

• CBT-I is effective across all patient populations including those with comorbid psychiatric conditions, medical conditions, and no comorbidities. 1

Components of Effective CBT-I

CBT-I is a multimodal intervention delivered over 4-8 sessions across 6 weeks that includes: 2, 3

• Sleep restriction therapy - limiting time in bed to increase sleep efficiency 1, 3
• Stimulus control therapy - associating the bed with sleep rather than wakefulness 1, 3
• Cognitive therapy - addressing unhelpful sleep-related beliefs and worry about consequences of poor sleep 1, 3
• Relaxation training - reducing physiological and mental hyperarousal 1, 3
• Sleep hygiene education - optimizing sleep environment, avoiding excessive caffeine, evening alcohol, and late exercise (insufficient as monotherapy but necessary as adjunct) 1, 3

Delivery Methods

• In-person, therapist-led programs are most beneficial, but digital CBT-I is an effective and scalable alternative when in-person therapy is unavailable. 2
• CBT-I can be delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all showing effectiveness. 2

Important Contraindications for Sleep Restriction

• Sleep restriction therapy may be contraindicated in patients with poorly controlled seizure disorders, bipolar disorder (risk of mania/hypomania), or those working in high-risk occupations (heavy machinery operators, drivers) due to sleep deprivation effects. 1

Second-Line Treatment: Pharmacotherapy

Pharmacotherapy should only be considered after CBT-I has been attempted or when CBT-I is unavailable, and should supplement—not replace—behavioral interventions. 2, 4

First-Line Pharmacological Agents

When medication is necessary, the American Academy of Sleep Medicine recommends: 4

For sleep onset insomnia:

• Zaleplon 10 mg 4
• Ramelteon 8 mg (melatonin receptor agonist) 4
• Zolpidem 10 mg (5 mg in elderly) 4
• Triazolam 0.25 mg (associated with rebound anxiety, not preferred) 4

For sleep maintenance insomnia:

• Eszopiclone 2-3 mg 4
• Zolpidem 10 mg (5 mg in elderly) 4
• Temazepam 15 mg 4
• Doxepin 3-6 mg (low-dose) 4
• Suvorexant (orexin receptor antagonist) 4

Special Considerations for Comorbid Conditions

For patients with comorbid depression or anxiety: Sedating antidepressants are the preferred initial pharmacological choice as they simultaneously address both the mood disorder and sleep disturbance. 4

For patients with cardiovascular disease: Avoid long-acting benzodiazepines; consider ramelteon or low-dose doxepin with careful monitoring. 4, 5

Critical Safety Warnings from FDA Drug Labels

Zolpidem (and all sedative-hypnotics) carry serious risks: 6

• Complex sleep behaviors (sleep-driving, sleep-walking, preparing food, making phone calls, having sex) can occur after the first or any subsequent dose, with or without alcohol—discontinue immediately if this occurs 6
• CNS-depressant effects and next-day impairment, especially with less than 7-8 hours of sleep remaining 6
• Higher risk of falls in elderly patients 6
• Failure of insomnia to remit after 7-10 days requires evaluation for underlying sleep disorders (sleep apnea, restless legs syndrome) 6

Suvorexant (Belsomra) specific warnings: 7

• Dose-dependent increase in suicidal ideation observed in clinical trials—immediately evaluate patients with suicidal thoughts 7
• Complex sleep behaviors, sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms can occur 7
• Not studied in severe obstructive sleep apnea or severe COPD 7
• Higher risk of falls in elderly patients 7

Agents NOT Recommended

The American Academy of Sleep Medicine explicitly recommends against the following: 4

• Over-the-counter antihistamines (diphenhydramine) - lack of efficacy data, daytime sedation, delirium risk especially in elderly 4
• Trazodone - not recommended for sleep onset or maintenance insomnia 4
• Tiagabine (anticonvulsant) - not recommended 4
• Herbal supplements (valerian) and melatonin - insufficient evidence of efficacy 4
• Barbiturates and chloral hydrate - not recommended 4

Dosing Considerations for Elderly Patients (≥65 years)

• Zolpidem maximum dose is 5 mg (not 10 mg) due to increased sensitivity and fall risk in older adults. 4
• All hypnotics carry increased risks of falls, cognitive impairment, and complex sleep behaviors in elderly patients. 4, 6
• Use the lowest effective dose for the shortest duration possible. 4

Treatment Algorithm

1. Initiate CBT-I immediately as first-line treatment for all patients with chronic insomnia 1, 2

2. If CBT-I is insufficient after adequate trial (4-8 sessions over 6 weeks) or unavailable, add pharmacotherapy through shared decision-making 2, 4

3. Select medication based on symptom pattern: 4

   • Sleep onset difficulty: zaleplon, ramelteon, or zolpidem
   • Sleep maintenance: eszopiclone, temazepam, doxepin, or suvorexant
   • Comorbid depression/anxiety: sedating antidepressants

4. Start with lowest effective dose for shortest duration 4

5. Reassess after 1-2 weeks to evaluate efficacy and monitor for adverse effects (morning sedation, cognitive impairment, complex sleep behaviors) 4

6. If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) 6, 7

7. Continue CBT-I alongside any pharmacotherapy as behavioral interventions provide more sustained effects than medication alone 2, 4

Common Pitfalls to Avoid

• Never prescribe hypnotics as first-line treatment without attempting CBT-I—this violates guideline recommendations and deprives patients of more effective, durable therapy. 1, 2

• Never rely on sleep hygiene education alone—it lacks efficacy as a single intervention and must be combined with other CBT-I components. 1, 3

• Never use standard adult doses of zolpidem (10 mg) in elderly patients—maximum dose is 5 mg due to increased fall risk. 4

• Never combine multiple sedative medications—this significantly increases risks of complex sleep behaviors, cognitive impairment, falls, and fractures. 4

• Never continue pharmacotherapy long-term without periodic reassessment and attempts to taper when conditions allow. 4

• Never fail to screen for underlying sleep disorders (sleep apnea, restless legs syndrome) if insomnia persists beyond 7-10 days of treatment. 6, 7

• Never expect immediate results from CBT-I—counsel patients that improvements are gradual but sustained, unlike pharmacotherapy which degrades after discontinuation. 2