Guideline-Directed Medical Treatment for 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 any pharmacological intervention. 1, 2
Primary Treatment: CBT-I
The American Academy of Sleep Medicine issues a STRONG recommendation that clinicians use multicomponent cognitive behavioral therapy for insomnia as the standard of care. 1 This represents the highest level of evidence-based recommendation and should be followed under most circumstances.
Core Components of Effective CBT-I
CBT-I must include at least three of the following evidence-based components 1, 2:
- Sleep restriction therapy - Limiting time in bed to actual sleep time, then gradually expanding the sleep window 1
- Stimulus control therapy - Reassociating the bed with sleep by going to bed only when sleepy, leaving bed if unable to sleep within 15-20 minutes, and using the bed only for sleep and sex 1
- Cognitive restructuring - Addressing maladaptive beliefs about sleep consequences and unrealistic sleep expectations 1, 2
- Relaxation techniques - Progressive muscle relaxation, guided imagery, or breathing exercises 1
- Sleep hygiene education - Environmental and behavioral optimization, though insufficient as monotherapy 1
CBT-I Delivery Formats
CBT-I demonstrates equivalent efficacy across multiple delivery methods 2, 3:
- Individual face-to-face therapy (4-10 sessions) 4, 5
- Group therapy sessions 2
- Telephone-based programs 2
- Web-based digital CBT (dCBT) platforms 2, 3
- Self-help books with structured protocols 2
Expected Outcomes from CBT-I
CBT-I produces clinically meaningful improvements that are sustained long-term 6:
- Sleep onset latency reduces by 19 minutes 6
- Wake after sleep onset reduces by 26 minutes 6
- Sleep efficiency improves by 9.91% 6
- Benefits persist for up to 2 years after treatment completion 2, 7
Pharmacological Treatment (Second-Line Only)
Medications should only be considered when patients cannot participate in CBT-I, still have residual symptoms despite CBT-I, or as a temporary adjunct to CBT-I—never as monotherapy. 1, 2, 7
First-Line Pharmacotherapy Options
When pharmacotherapy is necessary, the American Academy of Sleep Medicine recommends short/intermediate-acting benzodiazepine receptor agonists (BzRAs) or ramelteon 1, 2, 8:
For sleep onset insomnia:
- Zaleplon 10 mg (5 mg in elderly) 2, 8
- Zolpidem 10 mg (5 mg in elderly) 2, 8
- Ramelteon 8 mg 2, 8
- Triazolam 0.25 mg (though associated with rebound anxiety) 8
For sleep maintenance insomnia:
- Eszopiclone 2-3 mg 2, 8
- Zolpidem 10 mg (5 mg in elderly) 2, 8
- Temazepam 15 mg 2, 8
- Low-dose doxepin 3-6 mg 2, 8
- Suvorexant (orexin receptor antagonist) 2, 8
Second-Line Pharmacotherapy
Sedating antidepressants should be considered when comorbid depression or anxiety is present 1, 2, 8:
- Low-dose doxepin 3-6 mg (reduces wake after sleep onset by 22-23 minutes) 2, 7, 8
- Mirtazapine (requires nightly scheduled dosing, not PRN) 7, 8
Medications Explicitly NOT Recommended
The American Academy of Sleep Medicine recommends against the following 1, 2, 7:
- Over-the-counter antihistamines (diphenhydramine, doxylamine) - Lack efficacy data, cause daytime sedation, anticholinergic effects, and delirium risk in elderly 2, 7, 8
- Trazodone - Insufficient efficacy evidence, harms outweigh benefits 7, 8
- Antipsychotics (quetiapine, olanzapine) - Problematic metabolic side effects, lack of efficacy evidence 7, 8
- Long-acting benzodiazepines - Increased fall risk, cognitive impairment, drug accumulation 2, 7
- Herbal supplements and melatonin - Insufficient evidence of efficacy 1, 2, 8
- Sleep hygiene as monotherapy - Insufficient for chronic insomnia treatment 1
Treatment Algorithm
Step 1: Initial Assessment and CBT-I Implementation
- Establish diagnosis using ICSD-3 or DSM-5 criteria 1
- Initiate multicomponent CBT-I immediately 1, 2
- Implement 2-week sleep diary to document patterns 8
- Assess for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) 2, 8
Step 2: Evaluate CBT-I Response
- Reassess after 4-8 weeks of CBT-I 5
- If insomnia persists beyond 7-10 days despite adequate CBT-I trial, evaluate for underlying sleep disorders 2, 7
- Continue CBT-I even if adding pharmacotherapy 1, 2
Step 3: Add Pharmacotherapy if Necessary
- Select medication based on primary sleep complaint pattern (onset vs. maintenance) 2, 8
- Start with lowest effective dose 2, 7
- Use short-term only (typically less than 4 weeks for acute insomnia) 7, 8
- Maintain concurrent CBT-I throughout medication use 1, 2
Step 4: Ongoing Management
- Reassess after 1-2 weeks of medication trial 7, 8
- Monitor for adverse effects: daytime sedation, cognitive impairment, complex sleep behaviors, falls 2, 7
- Taper medication when conditions allow, using CBT-I to facilitate discontinuation 2, 8
- Periodic reassessment is mandatory for any continued pharmacotherapy 2, 7
Special Population Considerations
Elderly Patients (Age 65+)
Elderly patients require significantly lower medication doses and have increased risk of adverse effects 2, 7, 8:
- Zolpidem maximum 5 mg (not 10 mg) 2, 7
- Avoid benzodiazepines entirely due to fall risk, cognitive impairment, and dementia associations 2, 7
- Preferred agents: ramelteon 8 mg or low-dose doxepin 3 mg (minimal fall risk) 8
- Monitor closely for complex sleep behaviors, falls, and cognitive changes 2, 7
Patients with Comorbid Depression or Anxiety
Sedating antidepressants are the preferred initial pharmacotherapy choice 8:
- Simultaneously address mood disorder and sleep disturbance 8
- Options include low-dose doxepin, mirtazapine (requires nightly dosing, not PRN) 7, 8
- CBT-I remains mandatory alongside pharmacotherapy 8
Patients with Substance Abuse History
- Avoid benzodiazepines completely 7
- Consider ramelteon (no abuse potential) or suvorexant 7
- Emphasize CBT-I as primary intervention 7
Critical Safety Considerations
All Hypnotics Carry Significant Risks
The FDA warns about serious adverse effects with all benzodiazepine and non-benzodiazepine hypnotics 2, 7:
- Complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating) 2, 7
- Daytime impairment and motor vehicle accidents 7, 8
- Falls and fractures, particularly in elderly 2, 7
- Cognitive and behavioral changes 2, 7
- Dependence and withdrawal reactions with prolonged use 7, 8
- Observational associations with dementia (primarily benzodiazepine data) 7, 8
Medication Discontinuation
Rapid discontinuation produces withdrawal symptoms including rebound insomnia 8:
- Taper gradually when discontinuing 8
- Intensify CBT-I during tapering period 4
- Monitor for rebound insomnia and withdrawal symptoms 8
Common Pitfalls to Avoid
Critical errors that compromise treatment outcomes 2, 7, 8:
Starting with medications before attempting CBT-I - Violates guideline recommendations and deprives patients of superior long-term treatment 2, 7
Using sleep hygiene education alone - Insufficient as monotherapy for chronic insomnia 1, 2
Prescribing over-the-counter antihistamines or herbal supplements - Lack efficacy data and carry safety concerns 2, 7, 8
Continuing pharmacotherapy long-term without reassessment - Increases risks without documented benefit 2, 7, 8
Using standard adult doses in elderly patients - Elderly require age-adjusted lower doses (e.g., zolpidem 5 mg maximum) 2, 7
Prescribing trazodone for insomnia - Explicitly not recommended by American Academy of Sleep Medicine 7, 8
Combining multiple sedative medications - Significantly increases fall risk, cognitive impairment, and respiratory depression 7, 8
Failing to assess for underlying sleep disorders - Sleep apnea, restless legs syndrome, and circadian rhythm disorders require specific treatment 2, 8
Using medications as monotherapy without behavioral interventions - Pharmacotherapy must supplement, not replace, CBT-I 1, 2, 7
Prescribing PRN hypnotics for chronic insomnia - Chronic insomnia requires scheduled treatment approach, not as-needed dosing 7, 8