What are the recommended treatment options for a patient with insomnia?

Treatment of Insomnia

First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)

All adults with chronic insomnia should receive CBT-I as the initial treatment before any pharmacological intervention. 1, 2, 3

• 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
• The treatment demonstrates superior long-term efficacy compared to medications, with sustained benefits after treatment ends and minimal adverse effects 1, 2
• CBT-I is effective for adults of all ages, including older adults and chronic hypnotic users 2

Core Components of CBT-I

CBT-I is a multicomponent intervention that must include at least three of the following elements 1, 4:

• 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 (go to bed only when sleepy, get out of bed if unable to sleep within 15-20 minutes, use 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: Progressive muscle relaxation, guided imagery, or breathing exercises 1
• Sleep hygiene education: While insufficient as monotherapy, should be included as part of comprehensive treatment (consistent wake time, avoiding caffeine/nicotine before bed, regular exercise, optimizing bedroom environment) 1, 2

Delivery Modalities

• In-person one-on-one delivery by a trained CBT-I provider is the most widely evaluated and generally considered the best available treatment 1
• Alternative effective delivery methods include group therapy, telephone-based programs, web-based modules, or self-help books when access to trained providers is limited 1, 2, 3
• Treatment typically requires 4-8 sessions over 6 weeks 3

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. 5, 2, 3

First-Line Pharmacotherapy

The following agents are recommended as first-line options when medication is necessary 5:

For Sleep Onset Insomnia:

• Zaleplon 10 mg (5 mg in elderly): Specifically targets sleep initiation 5
• Ramelteon 8 mg: Melatonin receptor agonist with minimal adverse effects and no dependence risk; FDA-approved for difficulty with sleep onset 5, 6
• Zolpidem 10 mg (5 mg in elderly/women): Effective for both sleep onset and maintenance 5, 7
• Triazolam 0.25 mg: Though associated with rebound anxiety and not considered optimal first-line 5

For Sleep Maintenance Insomnia:

• Eszopiclone 2-3 mg: Effective for both sleep onset and maintenance with moderate-to-large improvement in sleep quality 5
• Temazepam 15 mg: Intermediate-acting benzodiazepine receptor agonist 5
• Zolpidem 10 mg (5 mg in elderly/women): Addresses both initiation and maintenance 5

Second-Line Pharmacotherapy

• Doxepin 3-6 mg: Specifically for sleep maintenance insomnia, with moderate-quality evidence showing 22-23 minute reduction in wake after sleep onset 5
• Suvorexant: Orexin receptor antagonist for sleep maintenance insomnia 5
• Sedating antidepressants (mirtazapine, low-dose doxepin): Particularly appropriate when comorbid depression or anxiety is present 5

Medications NOT Recommended

• Trazodone: Explicitly not recommended by the American Academy of Sleep Medicine for sleep onset or maintenance insomnia 5
• Over-the-counter antihistamines (diphenhydramine, doxylamine): Not recommended due to lack of efficacy data, safety concerns, daytime sedation, and delirium risk especially in elderly 5, 8
• Herbal supplements (valerian) and melatonin: Insufficient evidence of efficacy 5
• Older hypnotics (barbiturates, chloral hydrate): Not recommended 5
• Antipsychotics (quetiapine, olanzapine): Should be avoided due to problematic metabolic side effects and lack of evidence 5
• Traditional benzodiazepines (lorazepam, diazepam, clonazepam): Not first-line; only considered if first-line agents fail and patient has comorbid anxiety or specific need for longer duration of action 5

Treatment Algorithm

1. Initiate CBT-I immediately as first-line treatment for all patients with chronic insomnia 1, 2, 3

2. If CBT-I is insufficient or unavailable, add pharmacotherapy using the following approach 5:

   • Assess primary sleep complaint (onset vs. maintenance vs. both)
   • Consider patient-specific factors (age, comorbidities, substance abuse history, medication interactions)
   • For sleep onset difficulty: zaleplon, ramelteon, or zolpidem 5
   • For sleep maintenance: eszopiclone, zolpidem, temazepam, doxepin, or suvorexant 5
   • For comorbid depression/anxiety: sedating antidepressants 5

3. If first-line medication unsuccessful, try alternative agent in same class before moving to second-line options 5

4. Use lowest effective dose for shortest duration possible, with regular reassessment 5

Special Population Considerations

Elderly Patients (≥65 years)

• Zolpidem maximum dose 5 mg (not 10 mg) due to increased sensitivity and fall risk 5
• Ramelteon 8 mg or low-dose doxepin 3 mg are safest choices due to minimal fall risk and cognitive impairment 5
• All benzodiazepine receptor agonists carry increased risks of falls, cognitive impairment, and complex sleep behaviors in older adults 5

Patients with Comorbid Conditions

• Depression/anxiety: Sedating antidepressants (mirtazapine, low-dose doxepin) as preferred initial pharmacotherapy 5
• Substance abuse history: Avoid benzodiazepines; consider ramelteon or suvorexant 5
• Seizure disorder or bipolar disorder: Use caution with sleep restriction component of CBT-I due to sleep deprivation effects 5

Critical Safety Considerations

• All benzodiazepine receptor agonists may cause complex sleep behaviors (sleep-driving, sleep-walking); patients must be warned and medication stopped immediately if these occur 5
• Driving impairment and motor vehicle accidents are documented risks with all hypnotics 5
• Observational studies suggest associations between hypnotic drugs and dementia, fractures, and major injuries 5
• Lower doses required in women and older adults due to cognitive and behavioral changes 5
• Combining multiple sedative medications significantly increases risks of cognitive impairment, falls, and fractures 5

Common Pitfalls to Avoid

• Failing to initiate CBT-I before or alongside pharmacotherapy: This deprives patients of more effective, durable therapy 5, 3
• Using sleep hygiene education alone: Insufficient as monotherapy; must be combined with other CBT-I components 1, 2
• Prescribing hypnotics as first-line treatment: Violates guideline recommendations 3
• Continuing pharmacotherapy long-term without periodic reassessment: Medications should be tapered when conditions allow 5
• Using over-the-counter sleep aids or herbal supplements: Limited efficacy data and potential safety concerns 5
• Failing to consider drug interactions and contraindications before prescribing 5
• Using traditional benzodiazepines (lorazepam, diazepam) as first-line: These carry significant risks without clear benefit over newer agents 5

Patient Education Requirements

Before prescribing any sleep medication, educate patients about 5:

• Treatment goals and realistic expectations
• Safety concerns and potential side effects
• Drug interactions and contraindications
• Importance of behavioral treatments alongside medication
• Risk of complex sleep behaviors and need to stop medication if they occur
• Expected gradual improvement with CBT-I (not immediate results) 5

Monitoring and Follow-Up

• Assess effectiveness after 1-2 weeks of pharmacotherapy: sleep latency, sleep maintenance, daytime functioning 5
• Monitor for adverse effects: morning sedation, cognitive impairment, complex sleep behaviors, falls 5
• Regular follow-up essential to assess ongoing need for medication and opportunities for tapering 5
• If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) 5