Treatment of Insomnia in Adults
Cognitive behavioral therapy for insomnia (CBT-I) is the mandatory first-line treatment for all adults with chronic insomnia disorder, regardless of age or comorbidities, and should be initiated before any pharmacological intervention is considered. 1, 2
Initial Treatment Approach
CBT-I as First-Line Therapy
- CBT-I receives a strong recommendation with moderate-quality evidence as the initial treatment for chronic insomnia disorder in all adult patients 1
- CBT-I is a multicomponent intervention combining cognitive therapy around sleep, behavioral interventions (sleep restriction and stimulus control), and sleep hygiene education 1
- Multiple delivery methods are effective, including in-person individual or group therapy, telephone-based, web-based modules, and self-help books 1
- CBT-I demonstrates clinically significant improvements in global outcomes including increased remission rates, reduced insomnia severity, improved sleep onset latency, reduced wake after sleep onset, and improved sleep efficiency 1
- CBT-I is specifically effective in older adults, with moderate-quality evidence showing reduced wake after sleep onset and improved sleep efficiency 1
Addressing Access Barriers
- When trained CBT-I providers are unavailable, digital CBT-I platforms are recommended as equally effective alternatives 2
- Brief behavioral therapy for insomnia (BBT), sleep restriction therapy alone, stimulus control alone, and relaxation therapy receive conditional recommendations when full CBT-I is not accessible 1
- Sleep hygiene as a single-component therapy is not recommended due to minimal benefits compared to control conditions 1
Pharmacological Treatment
When to Consider Medications
- Pharmacological therapy should only be added after CBT-I has been unsuccessful, using a shared decision-making approach that discusses benefits, harms, and costs 1
- This recommendation carries a weak grade due to low-quality evidence for long-term medication use 1
Short-Term Pharmacological Options (≤4 weeks)
First-tier medications:
- Benzodiazepines (triazolam, estazolam, temazepam, flurazepam, quazepam) for short-term use 2
- Benzodiazepine receptor agonists (Z-drugs): eszopiclone, zolpidem, zaleplon - low to moderate-quality evidence shows improved sleep onset latency, total sleep time, and wake after sleep onset 1, 2
- Daridorexant (dual orexin receptor antagonist) with strong evidence 2
- Low-dose sedating antidepressants (particularly doxepin) - moderate-quality evidence in older adults for improved insomnia severity and sleep outcomes 1, 2
Longer-Term Pharmacological Options
- Orexin receptor antagonists (suvorexant, lemborexant, daridorexant) can be used for up to 3 months or longer, with moderate-quality evidence showing improved treatment response and sleep outcomes 1, 2, 3
- Prolonged-release melatonin 2 mg can be used for up to 3 months specifically in patients ≥55 years of age 2, 4
- Ramelteon showed no statistically significant difference from placebo in the general population but decreased sleep onset latency in older adults (low-quality evidence) 1
Medications NOT Recommended
- Antihistaminergic drugs (including diphenhydramine) are not recommended despite common use 2
- Antipsychotics are not recommended for insomnia treatment 2
- Fast-release melatonin is not recommended 2
- Phytotherapeutics lack sufficient evidence 2
Critical Safety Considerations
Medication Risks
- Observational studies demonstrate serious adverse effects with hypnotic drugs including dementia, serious injury, and fractures, particularly in older adults 1
- FDA warnings include daytime impairment, "sleep driving," behavioral abnormalities, and worsening depression 1
- The FDA recommends lower dosages than those used in many clinical trials, especially for older adults 1
- Evidence is insufficient to evaluate long-term benefits versus harms of pharmacologic treatments 1
Deprescribing Protocols
- Discontinuation of benzodiazepines and Z-drugs must be gradual, with dose reductions of 10-25% each week 4
- Multi-component CBT-I, daridorexant, eszopiclone, and melatonin 2 mg PR can facilitate gradual discontinuation within a cross-tapered program 4
- Daridorexant and melatonin 2 mg PR do not require special switching or deprescribing protocols 4
Special Population: Older Adults (≥65 years)
- CBT-I remains the first-line treatment with demonstrated efficacy in older adults 1, 2, 5
- Preferred pharmacological options when needed: low-dose doxepin, prolonged-release melatonin (≥55 years), ramelteon, and dual orexin receptor antagonists 5
- Increased caution is warranted due to age-related alterations in sleep physiology and higher risk of adverse effects from hypnotics 5
Adjunct Therapies
- Light therapy and exercise interventions may be useful as adjunct therapies to CBT-I (conditional recommendation) 2
- These should not replace CBT-I but can enhance its effectiveness 2
Diagnostic Evaluation Before Treatment
- Clinical interview encompassing sleep and medical history is essential 2
- Sleep questionnaires and diaries should be used 2
- Polysomnography is indicated for suspected comorbid sleep disorders (periodic limb movement disorder, sleep-related breathing disorders) or treatment-resistant insomnia 2
- Actigraphy is not recommended for routine evaluation but may be useful for differential diagnosis 2