What are the recommended treatments for insomnia?

Recommended Treatments for Insomnia

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

First-Line Treatment: CBT-I

CBT-I demonstrates superior long-term efficacy compared to medications, with sustained benefits lasting up to 2 years without risk of tolerance, dependence, or adverse effects. 1, 2

Core Components of Effective CBT-I

• Sleep restriction therapy limits time in bed to match actual sleep duration, creating mild sleep deprivation that strengthens homeostatic sleep drive and consolidates sleep 2

• Stimulus control therapy breaks the association between bed/bedroom and wakefulness through specific behavioral instructions 2

• Cognitive therapy targets maladaptive thoughts and beliefs about sleep using structured psychoeducation, Socratic questioning, and behavioral experiments 2

• Sleep hygiene education addresses environmental and behavioral factors (avoiding excessive caffeine, evening alcohol, late exercise, optimizing sleep environment), though this alone is insufficient as monotherapy 1, 2

CBT-I Delivery Formats

• CBT-I can be effectively delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all showing effectiveness 3, 4

• Face-to-face treatments of at least four sessions appear more effective than self-help interventions or fewer sessions 4

• Treatment typically consists of 4-10 weekly or biweekly sessions 5

CBT-I Efficacy Data

• 36.0% of patients receiving CBT-I achieve remission from insomnia compared to 16.9% in control conditions (odds ratio 3.28) 6

• Effect sizes are medium to large for most sleep parameters: sleep efficiency (g=0.91), sleep onset latency (g=0.80), wake after sleep onset (g=0.68), and sleep quality (g=0.84) 6

• CBT-I is effective for insomnia comorbid with psychiatric and medical conditions, with small to medium positive effects on comorbid symptoms 6, 7

Second-Line Treatment: Pharmacotherapy

Medications should only be considered when patients cannot participate in CBT-I, still have symptoms despite CBT-I, or as a temporary adjunct to CBT-I—never as monotherapy. 1, 2

First-Line Pharmacological Options

For sleep onset insomnia:

• Ramelteon 8 mg is recommended for sleep onset difficulty, with no abuse potential and safe for long-term use 1, 3, 8

• Zaleplon 10 mg (ultra-short-acting BzRA) can be used for sleep onset only and can be taken mid-night if ≥4 hours remain before awakening 1, 3

• Zolpidem 10 mg (5 mg in elderly) is effective for sleep onset, though carries increased risks in older adults 3, 9

For sleep maintenance insomnia:

• Low-dose doxepin 3-6 mg (highly selective H1 antagonist) reduces wake after sleep onset by 22-23 minutes with strong evidence 1, 3

• Suvorexant (orexin receptor antagonist) is recommended for sleep maintenance insomnia 1, 3

For both sleep onset and maintenance:

• Eszopiclone 2-3 mg addresses both sleep initiation and maintenance and is approved for long-term use 1, 3

• Temazepam 15 mg is suggested for both sleep onset and maintenance 3

Medications to Avoid

• Trazodone is explicitly NOT recommended due to insufficient efficacy data 1, 3

• Over-the-counter antihistamines (diphenhydramine) should not be used due to lack of efficacy data, daytime sedation, anticholinergic effects, and delirium risk, especially in older patients 1, 2, 3

• Benzodiazepines should be avoided due to higher risk of tolerance, dependence, cognitive impairment, falls, and complex sleep behaviors compared to newer agents 1, 3

• Antipsychotics should not be used as first-line treatment due to problematic metabolic side effects 1, 3

• Melatonin is not recommended for chronic insomnia treatment due to insufficient evidence 2

Treatment Algorithm

1. Start with CBT-I as primary intervention for all patients with chronic insomnia 1, 2, 3

2. If CBT-I is ineffective, unavailable, or patient cannot participate, consider pharmacotherapy as supplement (not replacement) 1, 2

3. Select medication based on symptom pattern:

   • Sleep onset only: ramelteon, zaleplon, or zolpidem 3
   • Sleep maintenance only: low-dose doxepin or suvorexant 3
   • Both onset and maintenance: eszopiclone or temazepam 3

4. Use lowest effective dose for shortest duration possible 3

5. Continue or implement CBT-I alongside any medication 1, 3

6. Regular follow-up to monitor effectiveness and side effects, with periodic reassessment 1, 3

Special Population Considerations

Older Adults (≥65 years)

• Use extra caution with medications due to increased risk of falls, cognitive impairment, and adverse effects 1

• Zolpidem maximum dose is 5 mg in elderly patients due to increased sensitivity 3, 9

• All hypnotics carry higher risks in elderly, including complex sleep behaviors, falls, fractures, and cognitive impairment 3

Patients with Comorbid Depression/Anxiety

• Sedating antidepressants are preferred initial choice as they simultaneously address both mood disorder and sleep disturbance 3

• CBT-I should still be started before or alongside any pharmacotherapy 3

Critical Pitfalls to Avoid

• Never use pharmacotherapy without implementing or optimizing CBT-I, as behavioral interventions provide more sustained effects than medication alone 1, 3

• Never combine multiple sedative medications, as this significantly increases fall risk, cognitive impairment, and complex sleep behaviors 1, 3

• Never continue pharmacotherapy long-term without periodic reassessment and concurrent behavioral interventions 1, 3

• Never use sleep hygiene education alone as it is insufficient as monotherapy for chronic insomnia 1, 2, 5

• Never prescribe benzodiazepines or antihistamines as first-line treatment due to unfavorable risk-benefit profiles 1, 2, 3