Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD

Summary

Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is suboptimal. Insomnia is considered a barrier to long-term adherence. The overarching theme of the proposal is to compare the effectiveness of cognitive behavioral therapy for insomnia (CBT) plus eszopiclone, a nonbenzodiazepine hypnotic, versus CBT alone in Veterans with PTSD who are diagnosed with both OSA and insomnia, using a randomized, clinical trial, on sleep quality of life, PTSD severity, and CPAP adherence.

Timeline

Start

2019-12-01

Primary completion

2024-09-30

Completion

2025-03-30

Outcome

Missed primary endpoint

registry analysis (other test); BBTI Plus Eszopiclone vs BBTI; p = 0.05; Mixed Models Analysis NCT03937713 ↗

paper No significant group allocation effects x time interactions were detected. PMID 40202618 ↗

Publications

• El-Solh AA, Lawson Y, Martinson A, Wilding G. Cognitive Behavioral Therapy Alone or in Combination with Eszopiclone in Comorbid Insomnia and Obstructive Sleep Apnea in Veterans with Posttraumatic Stress Disorder: A Randomized Trial. Psychiatr Q. 2025 Dec;96(4):787-802. doi: 10.1007/s11126-025-10143-9. Epub 2025 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	2 mg	Oral

Indications