It is considered chronic when it persists for three or more months at a frequency of at least three incidences per week. Insomnia disorder is defined as a complaint of difficulty initiating or maintaining sleep. The established placebo response models can serve as a tool to predict placebo response at different baseline levels, which help to inform clinical trial design, decision-making in drug development, and clinical practices related to the pharmacological management of insomnia.
This study quantified the distribution of the placebo response and identified a positive relationship between the severity of sleep parameters measured at baseline and the degree of their improvement. And, little is known about the magnitude of placebo responses in insomnia trials and what elements of clinical trials determine placebo variability. Placebo response in pharmacotherapy of insomnia varies considerably, making it difficult to prove the effectiveness of a new drug is superior to a placebo.
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