What are the treatment options for a patient with insomnia?

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 or alongside any pharmacotherapy. 1, 2, 3

First-Line Treatment: CBT-I

CBT-I produces clinically meaningful improvements in sleep parameters that are sustained for up to 2 years, unlike pharmacotherapy which shows degradation of benefit after discontinuation. 2, 3, 4

Core Components of 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 extinguishes the association between bed/bedroom and wakefulness by instructing patients to go to bed only when sleepy, get out of bed if unable to sleep within 15-20 minutes, and use the bed only for sleep and sex 1, 2
• Cognitive therapy targets maladaptive thoughts and beliefs about sleep using structured psychoeducation, Socratic questioning, thought records, and behavioral experiments 2
• Relaxation techniques such as progressive muscle relaxation, guided imagery, or breathing exercises are effective components 5
• Sleep hygiene education includes waking at the same time daily, exercising regularly, avoiding caffeine/nicotine before bedtime, and keeping the bedroom quiet and temperature-regulated, though this alone is insufficient as monotherapy 1, 5, 3

CBT-I Delivery Methods

• In-person, therapist-led programs are most beneficial, typically requiring 4-8 sessions over 6 weeks 3
• Digital CBT-I is an effective and scalable alternative when in-person therapy is unavailable 3
• Group therapy, telephone-based programs, web-based modules, and self-help books all show effectiveness 1, 2

Pharmacotherapy: When and What to Prescribe

Pharmacotherapy should only be considered after CBT-I has been attempted or when CBT-I is unavailable, and must always supplement—not replace—behavioral interventions. 1, 5, 2

First-Line Pharmacological Agents

For sleep onset insomnia:

• Zolpidem 10 mg (5 mg in elderly/women) is effective for both sleep onset and maintenance 5, 6
• Zaleplon 10 mg specifically for sleep onset 5
• Ramelteon 8 mg is a melatonin receptor agonist with minimal adverse effects and no dependence risk 5, 7

For sleep maintenance insomnia:

• Eszopiclone 2-3 mg addresses both sleep initiation and maintenance with moderate-to-large improvement in sleep quality and 28-57 minute increase in total sleep time 5
• Temazepam 15 mg for both sleep onset and maintenance 5
• Low-dose doxepin 3-6 mg specifically for sleep maintenance, reducing wake after sleep onset by 22-23 minutes 5

Second-Line Options

• Suvorexant (orexin receptor antagonist) for sleep maintenance insomnia, reducing wake after sleep onset by 16-28 minutes 5
• Sedating antidepressants (mirtazapine, low-dose doxepin) particularly when comorbid depression/anxiety is present 5, 2

Agents NOT Recommended

• Trazodone is explicitly not recommended for sleep onset or maintenance insomnia 5
• Over-the-counter antihistamines (diphenhydramine) are not recommended due to lack of efficacy data, daytime sedation, and delirium risk especially in elderly 5
• Herbal supplements (valerian) and melatonin have insufficient evidence of efficacy 5
• Antipsychotics (quetiapine, olanzapine) are problematic due to metabolic side effects and lack of evidence 5
• Sleep hygiene alone as single-component therapy is insufficient and should not be prescribed as monotherapy 1, 3

Treatment Algorithm

1. Initiate CBT-I immediately for all patients with chronic insomnia (sleep problems ≥3 nights/week for ≥3 months) 1, 2

2. If CBT-I insufficient after 4-8 weeks, add pharmacotherapy based on symptom pattern:

   • Sleep onset difficulty: Zaleplon 10 mg, ramelteon 8 mg, or zolpidem 10 mg (5 mg elderly/women) 5
   • Sleep maintenance difficulty: Eszopiclone 2-3 mg, doxepin 3-6 mg, or suvorexant 5
   • Both onset and maintenance: Eszopiclone 2-3 mg, zolpidem 10 mg (5 mg elderly/women), or temazepam 15 mg 5

3. If first-line medication fails, try alternative agent from same class before moving to second-line 5

4. If comorbid depression/anxiety present, consider sedating antidepressants as second-line 5, 2

5. Reassess after 1-2 weeks to evaluate efficacy on sleep latency, sleep maintenance, daytime functioning, and monitor for adverse effects including morning sedation, cognitive impairment, and complex sleep behaviors 5

Critical Safety Considerations

• All hypnotics carry risks including daytime impairment, complex sleep behaviors (sleep-driving, sleep-walking), falls, fractures, and cognitive impairment, particularly in elderly 5
• Use lowest effective dose for shortest duration possible, typically less than 4 weeks for acute insomnia 5
• Elderly patients require dose reduction: zolpidem maximum 5 mg, consider ramelteon 8 mg or low-dose doxepin 3 mg as safest choices 5, 2
• FDA labeling indicates pharmacologic treatments are intended for short-term use, and patients should be discouraged from extended use 5
• Observational studies link benzodiazepine use to increased risk of dementia, fractures, and major injury 5
• Medication should be tapered when conditions allow to prevent discontinuation symptoms, with CBT-I facilitating successful discontinuation 5

Common Pitfalls to Avoid

• Do not prescribe hypnotics as first-line treatment without initiating CBT-I, as this violates guideline recommendations and deprives patients of more effective, durable therapy 1, 2, 3
• Do not use benzodiazepines like lorazepam or clonazepam as first-line treatment for insomnia 5
• Do not combine multiple sedative medications, as this significantly increases risks of complex sleep behaviors, cognitive impairment, falls, and fractures 5
• Do not continue pharmacotherapy long-term without periodic reassessment 5
• Do not expect immediate results from CBT-I—counsel patients that improvements are gradual but sustained 5
• Do not use sleep hygiene education alone, as it lacks efficacy as a single intervention 1, 3

Special Population Considerations

Elderly patients (≥65 years):

• More likely to report sleep maintenance problems rather than sleep onset difficulty 1
• Require lower medication doses: zolpidem 5 mg maximum, ramelteon 8 mg, or doxepin 3 mg 5, 2
• Higher risk of falls, cognitive impairment, and complex sleep behaviors with all hypnotics 5

Patients with comorbid depression/anxiety:

• CBT-I remains first-line treatment 2
• If medications needed, sedating antidepressants (mirtazapine, low-dose doxepin) are preferred as they simultaneously address mood disorder and sleep disturbance 5, 2

Patients with substance abuse history:

• Avoid benzodiazepines 5
• Consider ramelteon or suvorexant as safer alternatives 5