Combination treatment with cognitive behavioral therapy for insomnia and pharmacotherapy may offer modest benefits compared with medication alone but does not provide clinically meaningful improvements over cognitive behavioral therapy for insomnia alone, according to a new clinical practice guideline from the American Academy of Sleep Medicine (AASM).
The guideline, based on a systematic review and meta-analysis of randomized controlled trials, provides evidence-based recommendations for the management of chronic insomnia disorder in adults. Combination therapy was defined as the concurrent initiation of cognitive behavioral therapy for insomnia (CBT-I) and insomnia medication. The recommendations clarify how combination therapy compares with established treatment approaches.
CBT-I remains the preferred first-line treatment
The AASM task force issued two conditional recommendations (both based on low-certainty evidence):
- For combination therapy over pharmacotherapy alone
- Against combination therapy over CBT-I alone
Compared with medication alone, combination therapy led to small, clinically meaningful improvements in global insomnia severity and sleep continuity, although these benefits were modest. Combination treatment was also associated with slightly higher rates of adverse effects, particularly morning sleepiness.
In contrast, adding medication to CBT-I did not result in clinically meaningful improvements in insomnia severity, sleep continuity, or daytime functioning. Although some analyses suggested a short-term increase in total sleep time (TST) with combination therapy, this did not translate into clinically meaningful improvements in other key outcomes.
Taken together, the recommendations support CBT-I as the preferred first-line treatment, with combination therapy considered in selected circumstances and pharmacotherapy alone reserved for specific clinical scenarios.
Individualized treatment decisions remain central
The guideline emphasizes shared decision-making, particularly given the conditional nature of the recommendations, with treatment selection guided by patient preferences, clinical priorities, and access to care.
- Combination therapy may be appropriate for patients who:
- Prioritize rapid symptom relief
- Prioritize short-term increases in total sleep time
- Require quicker improvement for functional or safety reasons
- CBT-I alone may be preferred for patients who:
- Prioritize long-term improvements
- Seek better daytime functioning
- Wish to avoid medication-related adverse effects
Pharmacotherapy alone remains a reasonable option when CBT-I is unavailable, unaffordable, or not feasible, or when patients are unable to engage in behavioral interventions.
Evidence limitations and research gaps
The certainty of evidence supporting these recommendations was low, reflecting several limitations:
- A small number of RCTs directly comparing treatment strategies
- Emphasis on short-term outcomes, with limited long-term data
- Limited representation of diverse populations
- Narrow range of studied medications, primarily older hypnotics
Notably, newer agents such as dual orexin receptor antagonists have not been studied in combination with CBT-I. In addition, most trials evaluated concurrent treatment, whereas real-world care often involves sequential strategies (e.g., adding CBT-I after medication or vice versa), for which evidence remains insufficient.
Access and equity considerations
Limited access to CBT-I remains a major barrier to optimal care. The guideline highlights disparities in availability, particularly in underserved and rural areas, which may lead to greater reliance on pharmacotherapy.
Digital CBT-I and telemedicine approaches may help expand access, although challenges related to cost, engagement, and technology access persist. Improving availability of behavioral treatments is critical to reducing inequities in insomnia care.
Clinical implications
Overall, the guideline reinforces a pragmatic, patient-centered approach to care:
- CBT-I is preferred as first-line therapy
- Combination therapy is favored over medication alone but not over CBT-I
- Pharmacotherapy alone remains appropriate in selected situations
Clinicians are encouraged to tailor treatment strategies using shared decision-making, balancing clinical effectiveness, patient preferences, and access to care.
Disclosures are available in the published guideline.
