Treatment of Insomnia: Latest Guidelines
First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I is the mandatory initial treatment for all adults with chronic insomnia and must be implemented before or alongside any pharmacological intervention. 1, 2
- CBT-I demonstrates superior long-term efficacy compared to medications, with durable benefits that persist beyond treatment completion and minimal risk of adverse effects 1, 2
- The therapy consists of multiple evidence-based components that should be combined: stimulus control therapy, sleep restriction therapy, cognitive restructuring around sleep beliefs, and relaxation techniques 2
- CBT-I can be effectively delivered through individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books—all formats show comparable effectiveness 1
- Sleep hygiene education alone is insufficient as monotherapy but must be incorporated with other CBT-I components, including avoiding excessive caffeine, evening alcohol, late exercise, and optimizing the sleep environment 1, 2
Common pitfall: Sleep restriction therapy should be used cautiously in patients with seizure disorders or bipolar disorder due to potential sleep deprivation effects 1
Pharmacological Treatment Algorithm
When to Add Medications
Pharmacotherapy should only supplement—never replace—CBT-I, and is indicated when behavioral interventions are insufficient or unavailable 1, 2
First-Line Pharmacological Options
For sleep onset insomnia specifically:
For sleep maintenance insomnia specifically:
For combined sleep onset and maintenance insomnia:
Medication Selection Factors
The choice of specific agent must be directed by: symptom pattern (onset vs. maintenance), past treatment responses, comorbid conditions (especially depression/anxiety), contraindications, concurrent medication interactions, patient age, and side effect profile 3, 1
Second-Line and Alternative Options
If first-line agents fail or are contraindicated:
- Alternative short-intermediate acting benzodiazepine receptor agonists from the first-line list 3, 1
- Sedating antidepressants (trazodone, amitriptyline, doxepin, mirtazapine) are preferred when comorbid depression/anxiety exists 3, 1
- Lemborexant or daridorexant (newer orexin receptor antagonists) may be considered, though carry only weak recommendation strength 1, 4
Important distinction: Trazodone is explicitly NOT recommended by the American Academy of Sleep Medicine for sleep onset or maintenance insomnia, despite common clinical use, as trials show harms outweigh benefits 1, 2
Medications NOT Recommended
The following should be avoided for chronic insomnia:
- Over-the-counter antihistamines (diphenhydramine) due to lack of efficacy data, daytime sedation, and delirium risk especially in elderly 1, 2
- Herbal supplements (valerian) and melatonin due to insufficient efficacy evidence 1, 2
- Barbiturates and chloral hydrate 3, 2
- Long-acting benzodiazepines (increased risks without clear benefit) 1
- Tiagabine (anticonvulsant) 1
Critical Safety Considerations and Monitoring
Initial Prescribing Principles
- Use the lowest effective dose for the shortest duration possible 1
- Prescribe short-term use only (typically less than 4 weeks for acute insomnia) 1
- All hypnotics carry risks including daytime impairment, complex sleep behaviors (sleep-driving, sleep-walking), falls, fractures, cognitive impairment, and driving impairment 1
Mandatory Patient Education Before Prescribing
Patients must be counseled about: treatment goals and realistic expectations, safety concerns, potential side effects and drug interactions, the importance of behavioral treatments, potential for dosage escalation, and risk of rebound insomnia 3, 2
Follow-Up Schedule
- Monitor patients every few weeks during the initial treatment period to assess effectiveness, side effects, and need for ongoing medication 3, 2
- Reassess after 1-2 weeks to evaluate efficacy on sleep latency, sleep maintenance, daytime functioning, and adverse effects including morning sedation 1
- If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders such as sleep apnea, restless legs syndrome, or circadian rhythm disorders 1
Long-Term Management
- Efforts should be made to employ the lowest effective maintenance dosage and taper medication when conditions allow 3
- Medication tapering and discontinuation are facilitated by concurrent CBT-I 3
- Long-term administration may be nightly, intermittent (three nights per week), or as needed based on symptom pattern 3
Special Population: Elderly Patients (Age 65+)
Elderly patients require age-adjusted dosing and heightened monitoring:
- Zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity and fall risk 1
- Temazepam 7.5 mg for elderly or debilitated patients 2
- Higher risk of falls, cognitive impairment, complex sleep behaviors, and fractures with all hypnotics 1
- Benzodiazepines should be avoided in older adults and those with cognitive impairment 1
Common pitfall: Using doses appropriate for younger adults in elderly patients without age adjustment 1
Comorbid Depression/Anxiety
When insomnia coexists with depression or anxiety:
- Sedating antidepressants become the preferred initial pharmacological choice as they simultaneously address both conditions 3, 1
- Options include: trazodone, amitriptyline, doxepin (higher doses than used for insomnia alone), and mirtazapine 3
- CBT-I must still be initiated alongside antidepressant therapy 1
- For patients with cardiovascular disease, sertraline has lower QTc prolongation risk than citalopram/escitalopram, and mirtazapine is safe while aiding sleep 1
Combined Therapy Approach
- Combined therapy (CBT-I plus medication) shows no consistent advantage or disadvantage over CBT-I alone in long-term outcomes 3
- However, combining multiple sedative medications significantly increases risks including complex sleep behaviors, cognitive impairment, falls, and fractures, particularly in elderly patients 1
- The decision to combine treatments should be based on symptom pattern, treatment goals, past responses, comorbid conditions, and contraindications 3