Treatment Approach for Insomnia
First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)
All patients with chronic insomnia must receive CBT-I as the initial treatment intervention before any pharmacological therapy is considered. 1, 2 This is a strong recommendation based on the American Academy of Sleep Medicine and American College of Physicians guidelines, with CBT-I demonstrating sustained benefits lasting up to 2 years after treatment completion. 2, 3
Core Components of Effective CBT-I
CBT-I must include at least three of the following evidence-based components 1, 2:
- Sleep restriction therapy: Limits time in bed to match actual sleep time, consolidating sleep and increasing sleep drive 2
- Stimulus control therapy: Re-establishes the bed as a cue for sleep rather than wakefulness 1, 2
- Cognitive restructuring: Addresses maladaptive thoughts and beliefs about sleep 2
- Relaxation techniques: Reduces physiological and cognitive arousal 1, 4
- Sleep hygiene education: Must be combined with other components, as it is insufficient as monotherapy 1, 2
Delivery Formats
CBT-I can be effectively delivered through multiple formats, all showing comparable efficacy 2, 3:
- Individual face-to-face therapy 4
- Group therapy sessions 2
- Telephone-based programs 2
- Web-based digital modules 5
- Self-help books with structured guidance 2
This flexibility addresses common barriers including cost, geographic limitations, and provider availability. 2
When to Consider Pharmacotherapy
Pharmacological treatment should only be added in specific circumstances 1, 2:
- Patients unable to participate in CBT-I due to cognitive impairment, severe psychiatric illness, or logistical constraints 1
- Persistent symptoms despite adequate CBT-I trial (typically 4-8 weeks) 1
- As a temporary adjunct to CBT-I in select cases during the initial treatment phase 1
Critical principle: Pharmacotherapy must supplement, not replace, CBT-I, as medications alone lack the durable long-term effects seen with behavioral interventions. 1, 3
Pharmacological Treatment Algorithm
First-Line Medications
When pharmacotherapy is indicated, the American Academy of Sleep Medicine recommends short/intermediate-acting benzodiazepine receptor agonists (BzRAs) or ramelteon as first-line agents 1, 2, 6:
For sleep onset insomnia 2, 6:
- Zaleplon 10 mg
- Zolpidem 10 mg (5 mg maximum in elderly)
- Ramelteon 8 mg (melatonin receptor agonist)
- Triazolam 0.25 mg (not preferred due to rebound anxiety risk)
For sleep maintenance insomnia 2, 6:
- Eszopiclone 2-3 mg
- Zolpidem 10 mg (5 mg in elderly)
- Temazepam 15 mg
- Doxepin 3-6 mg (low-dose formulation)
- Suvorexant (orexin receptor antagonist)
Second-Line Options
If first-line agents fail or are contraindicated 1, 6:
- Sedating antidepressants (trazodone, mirtazapine) for patients with comorbid depression/anxiety 1, 6
- Alternative orexin receptor antagonists (lemborexant, daridorexant) for sleep maintenance 6
Medications Explicitly NOT Recommended
The following should be avoided as they lack efficacy evidence or have unfavorable risk profiles 1, 2, 6:
- Over-the-counter antihistamines (diphenhydramine, doxylamine) - lack efficacy data, cause daytime sedation and delirium risk in elderly 1, 2
- Herbal supplements (valerian) and melatonin - insufficient evidence 1, 6
- Antipsychotics - problematic metabolic side effects without indication 1, 2
- Long-acting benzodiazepines - increased risks without clear benefit 1, 2
- Trazodone - explicitly not recommended by AASM due to harms outweighing benefits 6
Special Population Considerations
Elderly Patients (Age 65+)
Elderly patients require modified dosing and heightened monitoring 2, 6:
- Zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity 2, 6
- Avoid benzodiazepines entirely due to fall risk, cognitive impairment, and fracture risk 2
- Higher risk of complex sleep behaviors (sleep-walking, sleep-driving) 7
- Consider ramelteon or low-dose doxepin as safer alternatives 6, 8
Patients with Comorbid Depression/Anxiety
Sedating antidepressants are the preferred initial pharmacological choice for patients with comorbid mood disorders, as they simultaneously address both conditions 1, 6. However, CBT-I should still be initiated alongside medication. 2
Patients with Respiratory Compromise
Exercise caution with all hypnotics in patients with severe obstructive sleep apnea or severe COPD, as these medications have not been adequately studied in these populations 7, 8. Ramelteon has not been studied in severe sleep apnea and is not recommended. 8
Critical Safety Considerations
All hypnotic medications carry significant risks that must be discussed with patients 2, 7:
- Complex sleep behaviors: Sleep-driving, sleep-walking, eating, making phone calls while not fully awake, with amnesia for events 7, 8
- Daytime impairment: Driving impairment, cognitive slowing, increased accident risk 7
- Falls and fractures: Particularly in elderly patients 2
- Dependence and withdrawal: Risk increases with duration of use 1
- Worsening depression/suicidal ideation: Dose-dependent increase observed with suvorexant 7
If complex sleep behaviors occur, discontinue the medication immediately. 7, 8
Prescribing Principles
When prescribing hypnotics, adhere to these evidence-based principles 1, 2, 6:
- Use the lowest effective dose for the specific patient 2
- Prescribe for the shortest duration possible, typically less than 4 weeks for acute exacerbations 2
- Reassess after 1-2 weeks to evaluate efficacy on sleep latency, maintenance, and daytime functioning 6
- Monitor for adverse effects: Morning sedation, cognitive impairment, complex behaviors 6
- Taper when discontinuing to prevent withdrawal symptoms 6
When to Reassess for Underlying Disorders
If insomnia persists beyond 7-10 days of treatment, further evaluation is mandatory to identify primary psychiatric or medical illness 7, 8. Specifically assess for:
- Sleep apnea (snoring, witnessed apneas, daytime sleepiness) 6
- Restless legs syndrome (uncomfortable leg sensations, urge to move) 6
- Circadian rhythm disorders (delayed/advanced sleep phase) 6
- Unrecognized psychiatric disorders (depression, anxiety, PTSD) 1, 8
- Medical conditions (chronic pain, GERD, hyperthyroidism) 1
Common Pitfalls to Avoid
- Starting with medications before attempting CBT-I - This violates guideline recommendations and deprives patients of more effective, durable therapy 2, 3
- Using sleep hygiene education alone - Insufficient as monotherapy and must be combined with other CBT-I components 1, 2
- Prescribing over-the-counter antihistamines or herbal supplements - Lack efficacy data and carry safety concerns 1, 2
- Continuing pharmacotherapy long-term without reassessment - Increases risk of dependence and adverse effects 2, 6
- Using standard adult doses in elderly patients - Requires age-adjusted dosing (e.g., zolpidem 5 mg maximum) 2, 6
- Failing to educate patients about complex sleep behaviors - Patients must understand risks and report any episodes immediately 7, 8
- Combining multiple sedative medications - Significantly increases risks of cognitive impairment, falls, and complex behaviors 2
Patient Education Requirements
Before prescribing any sleep medication, educate patients about 6, 7, 8:
- Treatment goals and realistic expectations (improvement, not perfection)
- Safety concerns, particularly complex sleep behaviors and driving impairment
- Potential side effects specific to the medication
- The importance of continuing behavioral treatments alongside medication
- Avoiding alcohol and other CNS depressants while taking hypnotics
- Confining activities after taking medication to preparing for bed only