What is the recommended treatment protocol for a patient presenting with insomnia?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 2, 2026View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Insomnia Treatment Protocol

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

All adults with chronic insomnia must receive CBT-I as initial treatment before any pharmacological intervention, as it provides superior long-term efficacy with sustained benefits up to 2 years after discontinuation, unlike medications which lose effectiveness after stopping. 1, 2

Core CBT-I Components (Implement All)

Stimulus Control Therapy:

  • Use bed only for sleep and sex 3, 2
  • Leave bed if unable to fall asleep within 20 minutes; engage in relaxing activity until drowsy, then return 2
  • Maintain consistent wake time every morning regardless of sleep obtained 2

Sleep Restriction Therapy:

  • Calculate total sleep time from 2-week sleep diary 2
  • Restrict time in bed to match actual sleep time (minimum 5 hours) 2
  • Adjust weekly based on achieving >85% sleep efficiency (total sleep time/time in bed × 100%) 2
  • Contraindications: Seizure disorders, bipolar disorder, high-risk occupations (heavy machinery, driving) 2

Relaxation Training:

  • Progressive muscle relaxation, guided imagery, or abdominal breathing exercises 3, 2
  • Reduces somatic tension and cognitive arousal perpetuating sleep problems 3

Cognitive Therapy:

  • Address unhelpful beliefs like "I must get 8 hours" or "My day is ruined if I wake up" 2
  • Use structured psychoeducation, thought records, and behavioral experiments 3

Sleep Hygiene Education (Supplement Only, Never Monotherapy):

  • Wake at same time daily 1
  • Avoid caffeine after noon and evening alcohol 1
  • Exercise regularly but not within 3 hours of bedtime 1
  • Keep bedroom quiet, dark, and cool 1

CBT-I Delivery Options (All Formats Effective)

  • Individual therapy: 4-8 sessions over 6 weeks 2
  • Group therapy 1
  • Telephone-based programs 1
  • Web-based modules 1
  • Self-help books 1

Pharmacotherapy Algorithm (Only After or Alongside CBT-I)

Step 1: First-Line Medications

For Sleep Onset Insomnia:

  • Zaleplon 10 mg (5 mg in elderly) 1
  • Ramelteon 8 mg (minimal adverse effects, no dependence risk) 1
  • Zolpidem 10 mg (5 mg in elderly) 1
  • Triazolam 0.25 mg (associated with rebound anxiety, not preferred) 1

For Sleep Maintenance Insomnia:

  • Eszopiclone 2-3 mg (addresses both onset and maintenance) 1, 2
  • Zolpidem 10 mg (5 mg in elderly) 1
  • Temazepam 15 mg 1
  • Low-dose doxepin 3-6 mg (reduces wake after sleep onset by 22-23 minutes) 1, 2
  • Suvorexant 10 mg (orexin receptor antagonist, reduces wake after sleep onset by 16-28 minutes) 1

Step 2: Second-Line Options (If First-Line Fails)

For Comorbid Depression/Anxiety:

  • Sedating antidepressants: mirtazapine, low-dose doxepin 1
  • NOT trazodone (explicitly not recommended by American Academy of Sleep Medicine due to harms outweighing benefits) 1

Alternative Orexin Antagonists:

  • Lemborexant 5 mg (lower risk of cognitive/psychomotor effects than benzodiazepines) 1

Step 3: Agents to Consider Only After Multiple Failures

Benzodiazepines NOT Approved for Insomnia (e.g., lorazepam, clonazepam):

  • Consider only if: 1
    • First-line BzRAs have failed
    • Comorbid anxiety disorder present
    • Longer duration of action specifically needed for sleep maintenance
  • Significant risks: Dependence, withdrawal, cognitive impairment, falls (especially elderly), daytime sedation 1

Critical Dosing Adjustments

Elderly Patients (≥65 years):

  • Zolpidem maximum 5 mg (not 10 mg) 1, 2
  • Eszopiclone maximum 2 mg (start 1 mg) 1
  • Safest options: Ramelteon 8 mg or low-dose doxepin 3 mg (minimal fall risk) 1, 2

Hepatic Impairment:

  • Zaleplon 5 mg (clearance reduced 70% in compensated cirrhosis, 87% in decompensated) 1

Medications Explicitly NOT Recommended

Never Use:

  • Over-the-counter antihistamines (diphenhydramine): Lack efficacy data, cause daytime sedation and delirium risk in elderly 1
  • Herbal supplements (valerian): Insufficient evidence 1
  • Melatonin supplements: Insufficient evidence (except in documented deficiency) 1, 4
  • Antipsychotics (quetiapine, olanzapine): Significant metabolic side effects, seizures, weight gain without proven efficacy 1
  • Tiagabine: Not recommended 1
  • Barbiturates and chloral hydrate: Not recommended 1

Critical Safety Warnings

Complex Sleep Behaviors (All Hypnotics):

  • Sleep-driving, sleep-walking, sleep-eating can occur with first or any subsequent dose 5
  • Discontinue immediately if complex sleep behavior occurs 5
  • Risk increased with: alcohol, other CNS depressants, doses above recommended 5

Next-Day Impairment:

  • Risk increased if: 5
    • Less than 7-8 hours sleep time remaining
    • Higher than recommended dose
    • Coadministration with CNS depressants or alcohol
  • Warn patients against driving until response known 5

Falls and Fractures:

  • Elderly at highest risk due to drowsiness and decreased consciousness 5
  • Observational studies link hypnotic use to increased fractures and major injuries 1

Cognitive Impairment:

  • Anterograde amnesia can occur, especially with doses >10 mg zolpidem 5
  • Benzodiazepines cause marked cognitive impairment in elderly 1

Treatment Duration and Monitoring

Short-Term Use Principle:

  • Use lowest effective dose for shortest duration possible 1
  • Typical duration: Less than 4 weeks for acute insomnia 1
  • Evidence for long-term use (>4 weeks) is insufficient 1

Reassessment Schedule:

  • After 1-2 weeks: Evaluate efficacy on sleep latency, maintenance, daytime functioning 1
  • Monitor for: Morning sedation, cognitive impairment, complex sleep behaviors 1
  • If insomnia persists beyond 7-10 days: Evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) 5, 2

Discontinuation:

  • Taper medications when conditions allow to prevent withdrawal symptoms 1
  • CBT-I facilitates successful medication discontinuation 1

Special Populations

Patients with Depression:

  • Monitor for worsening depression and suicidal ideation 5
  • Prescribe smallest feasible quantity due to overdose risk 5
  • Consider sedating antidepressants as first-line pharmacotherapy 1

Patients with Dementia/Alzheimer's Disease:

  • Avoid benzodiazepines (unacceptable risk-benefit ratio) 4
  • Consider: Trazodone 50 mg or orexin antagonists (suvorexant, lemborexant) 4
  • Implement bright light therapy (3,000-5,000 lux for 2 hours morning) 4
  • Structured physical and social activities during daytime 4

Patients with Substance Abuse History:

  • Avoid benzodiazepines 1
  • Consider ramelteon or suvorexant 1

Common Pitfalls to Avoid

  • Failing to initiate CBT-I before or alongside pharmacotherapy (medications alone provide inferior long-term outcomes) 1, 2
  • Using sedating agents without matching to specific sleep complaint (onset vs. maintenance) 1
  • Continuing pharmacotherapy long-term without periodic reassessment 1
  • Combining multiple CNS depressants (significantly increases risks of cognitive impairment, falls, complex sleep behaviors) 1
  • Using standard adult doses in elderly patients (requires age-adjusted dosing) 1, 2
  • Prescribing benzodiazepines as first-line treatment (should be second or third-line only) 1
  • Ignoring underlying sleep disorders (sleep apnea, restless legs syndrome) that present as insomnia 2, 5

References

Guideline

Pharmacotherapy of Insomnia

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Treatment of Chronic Intermittent Nighttime Awakening

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Treatment of Insomnia in Patients with Alzheimer's Disease

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.