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:
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