What is the recommended first-line treatment for an adult patient with insomnia, possibly with a history of sleep disorders or mental health conditions such as anxiety or depression?

Cognitive Behavioral Therapy for Insomnia (CBT-I) as First-Line Treatment

Cognitive behavioral therapy for insomnia (CBT-I) should be used as the initial treatment for all adults with chronic insomnia disorder, regardless of age or presence of comorbid psychiatric or medical conditions. 1, 2

Why CBT-I is the Standard of Care

The American College of Physicians and American Academy of Sleep Medicine both issue strong recommendations for CBT-I as first-line therapy based on its superior long-term efficacy, sustained benefits lasting up to 2 years, and favorable benefit-to-risk ratio compared to pharmacological options. 1, 2

Key Evidence Supporting CBT-I

• Meta-analyses demonstrate clinically significant improvements in remission rates, responder rates, sleep quality, sleep onset latency (reduced by 19 minutes), and wake after sleep onset (reduced by 26 minutes). 1, 3
• Sleep efficiency improves by approximately 10%, with effects sustained at long-term follow-up. 3
• CBT-I is effective across all patient subgroups, including those with no comorbidities, psychiatric comorbidities (depression, PTSD, anxiety), and medical comorbidities (cancer, fibromyalgia, chronic pain). 1, 4
• For patients with depression and comorbid insomnia, effect sizes are 0.5 for insomnia reduction and 0.5 for depression symptom improvement. 4
• For patients with PTSD and comorbid insomnia, effect sizes are particularly robust at 1.5 for insomnia reduction and 1.3 for PTSD symptom improvement. 4

Essential Components of Effective CBT-I

A complete CBT-I program must include at least three of the following core components to achieve optimal outcomes: 2, 5, 6

Critical Active Components (in order of efficacy):

• Cognitive restructuring (incremental odds ratio 1.68) - addresses maladaptive thoughts and beliefs about sleep using Socratic questioning, thought records, and behavioral experiments. 5, 6
• Third-wave components (incremental odds ratio 1.49) - includes mindfulness-based approaches and acceptance strategies. 6
• Sleep restriction therapy (incremental odds ratio 1.49) - limits time in bed to match actual sleep duration, creating mild sleep deprivation that strengthens homeostatic sleep drive and consolidates sleep. 2, 5, 6
• Stimulus control (incremental odds ratio 1.43) - strengthens the association between bed/bedroom and sleep by instructing patients to go to bed only when sleepy, use bed only for sleep and sex, leave bed if unable to sleep within 15-20 minutes, and maintain consistent wake times. 2, 5, 6

Components to Include or Avoid:

• Sleep hygiene education should be included as an adjunct but is insufficient as monotherapy (incremental odds ratio 1.01, essentially no effect). 2, 7, 6
• Relaxation procedures are potentially counterproductive (incremental odds ratio 0.81) and should not be emphasized. 6

Treatment Structure and Delivery

Standard CBT-I is delivered over 4-8 sessions with a trained CBT-I specialist, with in-person one-on-one delivery being most effective (incremental odds ratio 1.83). 5, 7, 6

• The most efficacious combination—cognitive restructuring, third-wave components, sleep restriction, and stimulus control delivered in-person—increases remission rates by 33% compared to psychoeducation alone, with a number needed to treat of 3.0. 6
• Brief Behavioral Therapy for Insomnia (BBT-I) is an abbreviated 1-4 session version emphasizing behavioral components, appropriate when resources are limited or patients prefer shorter treatment. 5, 7
• Digital and telehealth formats can increase access, though in-person delivery remains most effective. 1, 7
• Sleep diary data must be collected before and throughout treatment to monitor progress and guide adjustments. 5, 7

When to Consider Pharmacotherapy

Medications should only be considered as second-line treatment in the following specific circumstances: 2

• Patient is unable to participate in CBT-I (e.g., severe cognitive impairment, lack of access to trained providers)
• Patient still has significant symptoms despite completing an adequate trial of CBT-I
• As a temporary adjunct during CBT-I for severe symptoms (with plan for discontinuation)

Medication Options (if needed):

• Orexin receptor antagonists (suvorexant 10-20 mg, daridorexant) can be used for up to 3 months or longer, with no abuse potential. 2, 8
• Low-dose doxepin (3-6 mg) for sleep maintenance insomnia, reduces wake after sleep onset by 22-23 minutes. 2
• Benzodiazepine receptor agonists (eszopiclone 2-3 mg, zolpidem, zaleplon) for short-term use (≤4 weeks), though longer use may be considered in select cases. 2, 8
• Ramelteon (8 mg) for sleep onset insomnia, safe for long-term use with no abuse potential. 2

Critical Pitfalls to Avoid

• Never use sleep hygiene education alone as primary treatment—it is ineffectual as monotherapy and may make patients less receptive to effective behavioral interventions. 5, 7
• Do not prescribe medications as first-line treatment—this undermines long-term outcomes and creates dependency risk. 5
• Avoid over-the-counter antihistamines (diphenhydramine) due to lack of efficacy data, daytime sedation, anticholinergic effects, and delirium risk, especially in older adults. 2, 5
• Do not use trazodone for insomnia—the American Academy of Sleep Medicine explicitly recommends against it due to insufficient efficacy data. 2
• Avoid antipsychotics as first-line treatment due to problematic metabolic side effects. 2
• Do not use melatonin for chronic insomnia treatment (except prolonged-release formulation in patients ≥55 years)—insufficient evidence for efficacy. 5, 8
• Avoid benzodiazepines due to higher risk of tolerance, dependence, cognitive impairment, falls, and complex sleep behaviors compared to newer agents. 2

Special Populations and Contraindications

• Sleep restriction therapy may be contraindicated in patients working in high-risk occupations (e.g., commercial drivers, heavy machinery operators), those predisposed to mania/hypomania, or those with poorly controlled seizure disorders. 5, 7
• For older adults, CBT-I is particularly appropriate given the increased risk of falls, cognitive impairment, and adverse effects with medications. 5
• Temporary side effects during early CBT-I treatment include daytime fatigue, sleepiness, mood impairment, and cognitive difficulties, but these typically resolve by end of treatment. 7

Implementation Algorithm

1. Initiate CBT-I with a trained specialist, including cognitive restructuring, sleep restriction, stimulus control, and sleep hygiene education over 4-8 sessions. 1, 2, 6
2. Monitor progress with sleep diaries throughout treatment, adjusting time in bed based on sleep efficiency thresholds. 5, 7
3. If CBT-I is ineffective or not feasible, consider short-term pharmacotherapy with FDA-approved agents (orexin receptor antagonists preferred for longer use, BzRAs for short-term only). 2, 8
4. If combining medication with CBT-I, extend CBT-I throughout drug tapering to prevent relapse. 9
5. Follow-up regularly until insomnia stabilizes, then every 6 months to monitor for recurrence. 5