What are the recommended treatments for insomnia?

Insomnia Treatment

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for all patients with chronic insomnia and should be initiated before any pharmacological intervention. 1, 2, 3

Why CBT-I First?

CBT-I demonstrates superior long-term efficacy compared to medications, with sustained benefits lasting up to 2 years without risks of tolerance, dependence, or adverse effects inherent to pharmacological options 1, 3. Meta-analyses confirm robust effectiveness across all age groups and comorbid conditions, with large effect sizes for insomnia severity (Hedges g = 0.98), sleep efficiency (g = 0.71), and sleep quality (g = 0.65) 4, 5.

Essential CBT-I components that must be included: 1, 3

• Sleep restriction therapy: Limits time in bed to match actual sleep duration, creating mild sleep deprivation that strengthens homeostatic sleep drive
• Stimulus control therapy: Breaks the association between bed/bedroom and wakefulness through specific behavioral instructions
• Cognitive restructuring: Targets maladaptive thoughts and beliefs about sleep using structured psychoeducation and behavioral experiments
• Sleep hygiene education: Addresses environmental and behavioral factors (though insufficient as monotherapy)

Face-to-face CBT-I with at least four sessions is more effective than self-help interventions or abbreviated formats 5. Brief behavioral therapy (2-4 sessions emphasizing behavioral components) may be appropriate when resources are limited 2.

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Pharmacological Treatment (Second-Line Only)

When to Consider Medications

Medications should only be used when: 1, 2

• Patients are unable to participate in CBT-I
• Symptoms persist despite adequate CBT-I trial
• As a temporary adjunct to CBT-I

Critical principle: Use the lowest effective dose for the shortest period possible (typically less than 4 weeks for acute insomnia). 2

First-Line Pharmacological Options

For sleep onset insomnia: 2

• Ramelteon 8 mg: Melatonin receptor agonist, FDA-approved for difficulty with sleep onset, demonstrated efficacy in reducing latency to persistent sleep in trials up to 6 months 6
• Zaleplon 10 mg: Short-acting BzRA specifically for sleep onset 2
• Zolpidem 10 mg (5 mg in elderly): Effective for both sleep onset and maintenance, superior to placebo on sleep latency and efficiency in chronic insomnia trials 2, 7
• Triazolam 0.25 mg: For sleep onset, though associated with rebound anxiety and not considered first-line 2

For sleep maintenance insomnia: 2

• Eszopiclone 2-3 mg: Effective for both onset and maintenance 2
• Temazepam 15 mg: Intermediate-acting benzodiazepine for onset and maintenance 2
• Zolpidem 10 mg (5 mg in elderly): Also effective for maintenance 2

Second-Line Pharmacological Options

• Low-dose doxepin 3-6 mg: Specifically for sleep maintenance insomnia 2, 3
• Suvorexant (orexin receptor antagonist): For sleep maintenance 2
• Sedating antidepressants (amitriptyline, mirtazapine): Consider when comorbid depression/anxiety is present 2, 3

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What NOT to Use

The following are explicitly NOT recommended: 1, 2, 3

• Over-the-counter antihistamines (diphenhydramine): Lack efficacy data, cause daytime sedation and delirium especially in older patients
• Herbal supplements (valerian) and melatonin: Insufficient evidence of efficacy for chronic insomnia
• Trazodone: Not recommended for sleep onset or maintenance
• Antipsychotics: Should not be used as first-line due to problematic metabolic side effects
• Long-acting benzodiazepines: Increased risks without clear benefit
• Older hypnotics (barbiturates, chloral hydrate): Not recommended

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Treatment Algorithm

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

• All patients with chronic insomnia should start here
• Minimum 4 face-to-face sessions when possible
• Include all core components (sleep restriction, stimulus control, cognitive therapy, sleep hygiene)

Step 2: If CBT-I insufficient or unavailable 1, 2

• Consider short-term pharmacotherapy (typically <4 weeks)
• Select medication based on primary complaint:
  • Sleep onset difficulty: Ramelteon, zaleplon, or zolpidem
  • Sleep maintenance: Eszopiclone, zolpidem, temazepam, or low-dose doxepin
• Always supplement medication with behavioral/cognitive therapies when possible

Step 3: If first-line medications fail 2

• Try alternative BzRA in same class
• Consider sedating antidepressants if comorbid depression/anxiety present
• Reassess diagnosis and contributing factors

Step 4: Regular monitoring 1, 3

• Follow-up regularly during initial treatment period
• Assess effectiveness, side effects, and need for adjustments
• Periodic reassessment every 6 months once stabilized
• Taper medications when conditions allow

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Critical Pitfalls to Avoid

Do not: 1, 2, 3

• Use medications as first-line treatment without attempting CBT-I
• Continue pharmacotherapy long-term without periodic reassessment and concurrent behavioral interventions
• Prescribe medications without considering specific sleep complaint pattern (onset vs. maintenance)
• Use higher doses when lower doses are effective (e.g., 16 mg ramelteon confers no additional benefit over 8 mg and increases side effects) 6
• Ignore drug interactions and contraindications
• Prescribe long-acting benzodiazepines or antipsychotics for insomnia

Special caution in older adults: 1, 2

• Use extra caution with all medications due to increased risk of falls, cognitive impairment, and adverse effects
• Lower doses required (e.g., zolpidem 5 mg instead of 10 mg)
• Benzodiazepines and non-benzodiazepine hypnotics carry particularly high risks in this population