Combining Defined Sleep with CBT-I

CBT-I is the foundation

The American Academy of Sleep Medicine makes a strong recommendation for CBT-I in adults with chronic insomnia disorder (Edinger et al., Journal of Clinical Sleep Medicine, 2021). CBT-I typically runs four to eight sessions and combines cognitive strategies with education about sleep regulation and behavioral techniques such as stimulus control and sleep restriction. We encourage every appropriate patient to complete a full course.

Why combine therapies

Combination approaches have been studied directly. In a randomized trial of 160 adults with persistent insomnia, patients received six weeks of CBT-I alone or CBT-I together with a nightly sleep medication (Morin et al., JAMA, 2009). Response during the first six weeks was similar in both groups. The best long-term outcome came from patients who started with the combination and then continued with CBT-I alone: 68% were in remission at the six-month follow-up. That trial used zolpidem; its lesson for practice is that a nightly agent and CBT-I can be paired from the start, with CBT-I carrying the lasting benefit.

How Defined Sleep complements a CBT-I program

• A different outcome. Defined Sleep's clinical trial measured sleep architecture: the share of the night spent in deep and REM sleep, recorded nightly by validated wearable actigraphy. CBT-I works on the behaviors and thoughts that perpetuate insomnia. Together they address both.
• Non-sedating. Patients should expect gradual, natural drowsiness rather than being “knocked out,” so Defined Sleep sits comfortably with stimulus control and sleep restriction instructions.
• The same instructions. Two softgels one hour before bed, no caffeine within three hours, no alcohol within two hours, and the bed reserved for sleep. Patients hear one consistent message from both therapies.
• Suitable for nightly use. No adverse events were reported in the clinical trial.

Pairing them in practice

• Start or refer for CBT-I.
• Introduce Defined Sleep at the same visit, after checking the drug interaction list.
• Reinforce the shared sleep instructions at each CBT-I session.
• Review the patient's sleep diary and, if they use a wearable, their deep and REM sleep over the course of treatment.

Review the trial data Dosing & administration