DARIEN, IL – A new clinical practice guideline from the American Academy of Sleep Medicine 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, 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," said lead author Dr. Daniel J. Buysse, professor of psychiatry, medicine, and clinical and translational science at the University of Pittsburgh. "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."
Chronic insomnia disorder occurs in roughly 10% to 15% of adults and is commonly encountered in both primary care and specialty sleep medicine settings. Behavioral-psychological therapies and pharmacological treatments are among the most widely used approaches for managing the disorder.
Based on the available evidence, the guideline issues two conditional recommendations with low certainty of evidence. The AASM suggests the use of combination therapy with CBT‑I and a medication instead of using a medication alone, reflecting meaningful improvements in key sleep outcomes for some patients. In contrast, the guideline suggests against the use of combination therapy rather than using CBT‑I alone, as behavioral-psychological treatment by itself often produces meaningful and durable improvements without the added risks associated with pharmacotherapy. 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 this 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, taking into consideration the certainty of evidence, beneficial and harmful effects, patient values and preferences, and resource use. The draft guideline was posted for public comment, and the AASM board of directors approved the final recommendations.
The American Academy of Family Physicians affirmed the value of the guideline. The American Geriatrics Society affirmed the value of this document, which it defines as supporting the general principles in the document and believes it is of general benefit to its membership. This guideline was endorsed by the American Academy of Physician Associates, the Anxiety and Depression Association of America, the Canadian Sleep Society, the Nurse Practitioner Association of Canada, the Sleep Charity, the Sleep Health Foundation, and the Society of Behavioral Sleep Medicine.
The co-authors of the guideline are J. Todd Arnedt, Luis Buenaver, Dr. Judy L. Chang, Julio Fernandez-Mendoza, Dr. Salma I. Patel, Eric S. Zhou, Dr. Yngve Falck-Ytter, Suzanne Hyer, Uzma Kazmi, Dr. Mandeep Singh, and Emerson M. Wickwire.
View more AASM clinical practice guidelines and learn more about the guideline development process .
