The clinical practice guideline makes two conditional recommendations.
Key takeaways:
- Pharmacological and behavioral-psychological treatments are frequently used together to treat insomnia in clinical practice.
- CBT-I by itself is the most efficacious first-line treatment for insomnia.
- The recommendations are designed to support shared, patient-centered decision-making rather than a one-size-fits-all approach.
A new clinical practice guideline from the American Academy of Sleep Medicine (AASM) provides evidence‑based recommendations on the combined use of behavioral‑psychological and pharmacological therapies to treat chronic insomnia disorder in adults.
The guideline is published in the Journal of Clinical Sleep Medicine and is accompanied by a systematic review, meta-analysis, and evaluation of the comparative efficacy and potential harms of combination therapy.
Previous AASM clinical practice guidelines published in 2017 and 2021 recommended pharmacological therapy and behavioral-psychological treatment, such as cognitive behavioral therapy for insomnia (CBT-I), as individual treatment options for chronic insomnia disorder. However, those guidelines did not evaluate whether combining medications and CBT-I improves outcomes compared with either approach alone. Despite this lack of comparative evidence, pharmacological and behavioral-psychological treatments are frequently used together in clinical practice, either initiated simultaneously or added sequentially.
“Combination therapy for insomnia is widely used in clinical practice, yet the evidence guiding how and when to combine treatments has been surprisingly limited,” says lead author Daniel J. Buysse, MD, professor of psychiatry, medicine, and clinical and translational science at the University of Pittsburgh, in a release. “Our analysis suggests that CBT-I by itself is the most efficacious first-line treatment for insomnia. However, using medication with CBT-I may provide modest benefit for some specific outcomes, such as total sleep time. These recommendations are meant to support thoughtful, patient‑centered decision‑making rather than a one‑size‑fits‑all approach.”
Two Conditional Recommendations
Based on the available evidence, the guideline issues two conditional recommendations with low certainty of evidence.
Conditional recommendation for:
In adults with chronic insomnia disorder, the AASM suggests the use of combination treatment with CBT-I plus insomnia medication over insomnia medication alone. (Conditional recommendation, low certainty of evidence).
Conditional recommendation against:
In adults with chronic insomnia disorder, the AASM suggests against the use of combination treatment of CBT-I plus insomnia medication over CBT-I alone. (Conditional recommendation, low certainty of evidence).
Patients who place higher value on increasing total sleep time early in the course of treatment, and/or who place lower value on reducing daytime symptoms with treatment, may reasonably select combination treatment versus CBT-I alone, the authors remark.
The recommendations emphasize the importance of shared decision-making, taking into account patient values, treatment goals, and preferences when selecting an insomnia treatment strategy.
To develop the guideline, the AASM commissioned a task force of sleep medicine experts to systematically review the published literature and assess the benefits and harms of combination therapy.
The guideline was endorsed by nine leading medical and sleep health organizations, including the American Academy of Family Physicians, the American Geriatrics Society, and the Anxiety and Depression Association of America. Additional endorsers include the American Academy of Physician Associates, the Canadian Sleep Society, the Nurse Practitioner Association of Canada, the Sleep Charity, the Sleep Health Foundation, and the Society of Behavioral Sleep Medicine.
