Insomnia Treatment
First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)
All patients with chronic insomnia should receive CBT-I as the initial treatment before any pharmacological intervention. 1, 2, 3
Why CBT-I First
- 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, 4
- CBT-I provides sustained benefits without risk of tolerance, dependence, or adverse effects associated with medications 2, 4
- The American College of Physicians provides a strong recommendation (moderate-quality evidence) that CBT-I be used as initial treatment for all adults with chronic insomnia 3
- CBT-I is effective across all age groups, including older adults and chronic hypnotic users 2
Core Components of CBT-I
CBT-I is a multimodal intervention delivered over 4-8 sessions that includes: 2, 5
- 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 by establishing consistent sleep-wake schedules and removing wakeful activities from the bedroom 1, 2
- Cognitive therapy: Targets maladaptive thoughts and beliefs about sleep using structured psychoeducation, Socratic questioning, and behavioral experiments 2
- Relaxation techniques: Reduces physiological and mental hyperarousal 1, 5
- Sleep hygiene education: Addresses environmental and behavioral factors, though insufficient as monotherapy 1, 5
Delivery Modalities
- In-person, therapist-led programs are most beneficial, but digital CBT-I is an effective and scalable alternative when in-person therapy is unavailable 3
- CBT-I can be delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all showing effectiveness 1, 2
Pharmacological Treatment: When and What to Prescribe
Pharmacotherapy should only be considered after CBT-I has been attempted or when CBT-I is unavailable, and should supplement—not replace—behavioral interventions. 1, 6, 3
First-Line Pharmacotherapy Options
For sleep onset insomnia: 6
- Zaleplon 10 mg 6
- Ramelteon 8 mg (melatonin receptor agonist) 6
- Zolpidem 10 mg (5 mg in elderly) 6
- Triazolam 0.25 mg (associated with rebound anxiety, not preferred first-line) 6
For sleep maintenance insomnia: 6
- Eszopiclone 2-3 mg 6
- Zolpidem 10 mg (5 mg in elderly) 6
- Temazepam 15 mg 6
- Doxepin 3-6 mg (low-dose, second-line option) 6
- Suvorexant (orexin receptor antagonist) 6, 7
For both sleep onset and maintenance: 6
Second-Line and Alternative Options
- Doxepin 3-6 mg: Specifically recommended for sleep maintenance insomnia with moderate-quality evidence showing reduction in wake after sleep onset by 22-23 minutes 6
- Sedating antidepressants (e.g., mirtazapine, amitriptyline): Consider when comorbid depression/anxiety is present 6, 2
- Suvorexant: Orexin receptor antagonist for sleep maintenance, with moderate-quality evidence showing reduction in wake after sleep onset by 16-28 minutes 6, 7
Agents NOT Recommended
Do not prescribe the following: 6
- Trazodone: Explicitly not recommended by AASM for sleep onset or maintenance insomnia; harms outweigh benefits 6
- Over-the-counter antihistamines (e.g., diphenhydramine): Lack efficacy data, cause daytime sedation, and increase delirium risk especially in elderly 6
- Herbal supplements (e.g., valerian) and melatonin: Insufficient evidence of efficacy 6
- Tiagabine (anticonvulsant): Not recommended 6
- Barbiturates and chloral hydrate: Not recommended 6
Special Population Considerations
Elderly Patients (Age 65+)
Use lower doses of all hypnotics in older adults due to increased sensitivity and fall risk: 6, 2
- Zolpidem maximum 5 mg (not 10 mg) 6, 2
- Elderly patients are at higher risk for falls, cognitive impairment, complex sleep behaviors, and daytime sedation 6, 7
- Monitor closely for morning sedation and cognitive changes 6
Patients with Comorbid Depression/Anxiety
Sedating antidepressants are the preferred initial pharmacological choice when comorbid depression/anxiety is present, as they simultaneously address both conditions: 6, 2
- Consider mirtazapine or amitriptyline 6
- CBT-I remains first-line even in this population 2
- Monitor for worsening depression or suicidal ideation, particularly with hypnotics like suvorexant which showed dose-dependent increase in suicidal ideation in clinical studies 7
Patients with Medical Comorbidities
- Assess for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) if insomnia persists beyond 7-10 days of treatment 6, 7
- Suvorexant has not been studied in patients with severe obstructive sleep apnea or severe COPD; use caution in compromised respiratory function 7
Treatment Selection Algorithm
Step 1: Initiate CBT-I 1, 2, 3
- All patients should receive CBT-I as first-line treatment
- Deliver over 4-8 sessions using in-person or digital modalities
Step 2: If CBT-I insufficient or unavailable, add pharmacotherapy 1, 6
- Identify primary sleep complaint (onset vs. maintenance vs. both)
- Consider patient-specific factors: age, comorbidities, substance abuse history, medication interactions
Step 3: Select medication based on sleep pattern 6
- Sleep onset only: Zaleplon 10 mg, ramelteon 8 mg, or zolpidem 10 mg (5 mg elderly)
- Sleep maintenance only: Doxepin 3-6 mg, suvorexant, or eszopiclone 2-3 mg
- Both onset and maintenance: Eszopiclone 2-3 mg, zolpidem 10 mg (5 mg elderly), or temazepam 15 mg
- Comorbid depression/anxiety: Sedating antidepressants (mirtazapine, amitriptyline)
Step 4: Use lowest effective dose for shortest duration 6
- Prescribe short-term use only (typically less than 4 weeks for acute insomnia) 6
- Reassess after 1-2 weeks to evaluate efficacy and adverse effects 6
Step 5: If first-line medication fails 6
- Try alternative agent in same class
- Consider switching to different mechanism (e.g., BzRA to orexin antagonist)
- Reassess for underlying psychiatric or medical disorders 7
Critical Safety Considerations
All Hypnotics Carry Risks
Counsel patients about the following risks before prescribing any hypnotic: 6, 7
- Complex sleep behaviors: Sleep-walking, sleep-driving, eating, making phone calls while not fully awake—can occur after first dose or any subsequent use 7
- Daytime impairment: Driving impairment, cognitive and behavioral changes 6, 7
- Falls and fractures: Particularly in elderly patients 6, 7
- Worsening depression/suicidal ideation: Immediately evaluate any new behavioral signs or symptoms 7
- Anterograde amnesia: Particularly with doses above 10 mg zolpidem 8
Discontinue Immediately If:
- Patient experiences complex sleep behavior 7
- New suicidal ideation or behavioral changes emerge 7
- Insomnia fails to remit after 7-10 days, suggesting underlying psychiatric or medical disorder 7
Drug-Specific Warnings
Suvorexant (Belsomra): 7
- Dose-dependent increase in suicidal ideation observed in clinical studies
- Can cause sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms (leg weakness)
- Prescribe lowest number of tablets feasible at one time in patients with depression
Zolpidem: 8
- Use 5 mg maximum in elderly (not 10 mg)
- Statistically significant decrease in next-day performance on cognitive testing
- Anterograde amnesia can occur, especially at doses ≥10 mg
Common Pitfalls to Avoid
- Do not prescribe hypnotics as first-line treatment without attempting CBT-I—this violates guideline recommendations and deprives patients of more effective, durable therapy 1, 3
- Do not rely on sleep hygiene education alone—it lacks efficacy as a single intervention and must be combined with other CBT-I components 1, 5
- Do not use doses appropriate for younger adults in elderly patients—zolpidem requires age-adjusted dosing (5 mg maximum in elderly) 6, 2
- Do not continue pharmacotherapy long-term without periodic reassessment—medications should be used short-term with regular monitoring 6
- Do not prescribe trazodone for insomnia—AASM explicitly recommends against it 6
- Do not recommend over-the-counter antihistamines or herbal supplements—they lack efficacy data and carry safety concerns 6
- Do not fail to assess for underlying sleep disorders—if insomnia persists beyond 7-10 days of treatment, evaluate for sleep apnea, restless legs syndrome, or other primary sleep disorders 6, 7
- Do not combine multiple sedative medications—this significantly increases risks of complex sleep behaviors, cognitive impairment, falls, and fractures 6
Patient Education Requirements
Before prescribing any sleep medication, educate patients about: 6
- Treatment goals and realistic expectations
- Safety concerns and potential side effects
- Importance of behavioral treatments (CBT-I) alongside or instead of medication
- Risk of complex sleep behaviors and need to discontinue if they occur
- Caution against driving or hazardous activities until response is known
- Need for regular follow-up and reassessment