What are the treatment options for insomnia?

Treatment Options for Insomnia

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

First-Line Treatment: CBT-I

CBT-I is designated as the standard of care by the American Academy of Sleep Medicine and receives a strong recommendation from the American College of Physicians based on moderate-quality evidence. 1, 2 This approach produces clinically meaningful improvements that are sustained for up to 2 years, unlike pharmacotherapy which shows degradation of benefit after discontinuation. 2

Core Components of CBT-I

The most effective behavioral interventions include: 1

• Stimulus control therapy - establishing a positive association between bed and sleeping (Standard level evidence) 1
• Sleep restriction therapy - limiting time in bed to actual sleep time (Guideline level evidence) 1
• Cognitive therapy - addressing dysfunctional beliefs about sleep 1, 3
• Relaxation training - progressive muscle relaxation, breathing exercises (Standard level evidence) 1

Delivery Formats

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

• Individual therapy sessions (4-8 sessions over 6 weeks)
• Group therapy
• Telephone-based programs
• Web-based modules (digital CBT-I is an effective and scalable alternative)
• Self-help books

Important Caveat About Sleep Hygiene

Sleep hygiene education alone is insufficient as monotherapy and lacks efficacy as a single intervention. 1, 2 It must be combined with other CBT-I components. 1 Sleep hygiene includes avoiding excessive caffeine, evening alcohol, late exercise, and optimizing sleep environment, but should never be the sole treatment approach. 4, 5

Pharmacological Treatment Options

Pharmacotherapy should only be considered after CBT-I has been attempted or when CBT-I is unavailable, and should always supplement—not replace—behavioral interventions. 1, 4

First-Line Medications

The American Academy of Sleep Medicine recommends the following sequence: 1, 4

For sleep onset insomnia:

• Zolpidem 10 mg (5 mg in elderly) - FDA-approved for short-term treatment of insomnia characterized by difficulty with sleep initiation 4, 6
• Zaleplon 10 mg - specifically for sleep onset 4
• Ramelteon 8 mg - melatonin receptor agonist, FDA-approved for difficulty with sleep onset, non-DEA-scheduled (particularly appropriate for patients with substance use history) 4, 7
• Triazolam 0.25 mg - though associated with rebound anxiety and not considered first-line 4

For sleep maintenance insomnia:

• Eszopiclone 2-3 mg - addresses both sleep onset and maintenance 4
• Temazepam 15 mg - for both onset and maintenance 4
• Low-dose doxepin 3-6 mg - specifically for sleep maintenance 4
• Suvorexant - orexin receptor antagonist for sleep maintenance 4

Second-Line Options

If first-line medications are ineffective: 1, 4

• Sedating antidepressants - particularly when comorbid depression/anxiety is present (trazodone, amitriptyline, mirtazapine) 1, 4
• Combined BzRA or ramelteon with sedating antidepressant 1

Important note: Trazodone is NOT recommended by the American Academy of Sleep Medicine for sleep onset or maintenance insomnia despite widespread off-label use. 4

Third-Line Options (Use with Caution)

• Anti-epilepsy medications (gabapentin) 1
• Atypical antipsychotics (quetiapine, olanzapine) - only suitable for specific patient populations 1

Critical warning: Tiagabine is NOT recommended for insomnia. 4

Medications NOT Recommended

The following should be avoided: 4

• Over-the-counter antihistamines (diphenhydramine, hydroxyzine) - lack efficacy data and cause daytime sedation, delirium risk especially in elderly 4
• Herbal supplements (valerian) - insufficient evidence 4
• Melatonin - insufficient evidence for chronic insomnia 4, 2
• Older hypnotics (barbiturates, chloral hydrate) 4
• Long-acting benzodiazepines - increased risks without clear benefit 4

Treatment Selection Algorithm

When pharmacotherapy is necessary, selection should be directed by: 1

1. Symptom pattern (sleep onset vs. maintenance)
2. Treatment goals
3. Past treatment responses
4. Patient preference
5. Cost and availability
6. Comorbid conditions (depression, anxiety, substance use history)
7. Contraindications
8. Concurrent medication interactions
9. Side effects profile

Special Population Considerations

Elderly Patients (Age 65+)

• Use zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity and fall risk 4
• Higher risk of cognitive impairment, falls, fractures, and complex sleep behaviors 4
• Avoid benzodiazepines in older adults with cognitive impairment 4

Patients with Substance Use History

• Avoid benzodiazepines and BzRAs due to substantial risk of dependence 3
• Prefer ramelteon or melatonin as non-DEA-scheduled options 3
• CBT-I is especially critical in this population 3

Patients with Comorbid Depression/Anxiety

• Sedating antidepressants are the preferred initial choice as they simultaneously address both conditions 4
• Examples: mirtazapine, amitriptyline, doxepin 1, 4

Critical Safety Considerations

All hypnotics carry significant risks: 4

• Complex sleep behaviors (sleep-driving, sleep-walking)
• Daytime impairment and cognitive changes
• Falls and fractures (especially in elderly)
• Anterograde amnesia (particularly with doses >10 mg zolpidem) 6
• Driving impairment the morning after use

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

Monitoring and Follow-Up

Clinical reassessment should occur: 1

• Every few weeks initially until insomnia appears stable or resolved
• Every 6 months thereafter as relapse rate is high 1
• Collect sleep diary data before, during, and after treatment 1

Use the lowest effective dose for the shortest duration possible, with regular reassessment and attempts at medication tapering when conditions allow. 4, 3

Common Pitfalls to Avoid

• Never prescribe hypnotics as first-line treatment - this violates guideline recommendations and deprives patients of more effective, durable therapy 1, 2
• Never rely on sleep hygiene education alone - it must be combined with other CBT-I components 1, 2
• Never use doses appropriate for younger adults in elderly patients - age-adjusted dosing is essential 4
• Never fail to implement CBT-I alongside medication - behavioral interventions provide more sustained effects 4, 3
• Never continue pharmacotherapy long-term without periodic reassessment 4
• Never use over-the-counter sleep aids with limited efficacy data 4

When Initial Treatment Fails

If a single treatment or combination is ineffective: 1

• Consider other behavioral therapies
• Try alternative pharmacological therapies
• Implement combined therapies (CBT-I + medication)
• Reevaluate for occult comorbid disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) - especially if insomnia persists beyond 7-10 days of treatment 4