Are clinical trials for insomnia recruiting real-world patients?

Recent Phase III trials of hypnotic medications that have led to Food and Drug Administration approval have severely restrictive eligibility criteria. One hundred patients referred for insomnia who received a hypnotic medication at a large tertiary referral center were identified. Data were extracted to evaluate whether these patients would be eligible to be included in any of the recent Phase III trials. Of the 100 patients identified, only 3 were eligible. Most were excluded because of a prior or concurrent trial of cognitive behavioral therapy for insomnia. If this criterion were set aside, only 12% would have been eligible to participate. The remaining top reasons for exclusion were medical comorbidities, daytime napping, and sleep apnea. These findings question the generalizability of the regulatory studies and suggest that future trials should enroll patients with less-restrictive criteria to help determine the effectiveness of these medications in real-world settings.

Automated summary

Recent Phase III trials of hypnotic medications have severely restrictive eligibility criteria, with only 3 out of 100 referred insomnia patients receiving these medications being eligible. Only 12% would have been eligible if the criterion of prior or concurrent trial of cognitive behavioral therapy for insomnia were set aside. Medical comorbidities, daytime napping, and sleep apnea were the main reasons for exclusion. These findings question the generalizability of regulatory studies and call for future trials with less-restrictive criteria.