Sleep initiation and maintenance disorders — indication assessment

§1Assessment

§1.1Definition

Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.

§1.2Anchor and additional outcomes

The Institute designates one anchor outcome per indication so that estimates for different compounds are reported on a common measure. The anchor for this indication is the first outcome below.

1. Sleep-onset latency
2. Wake after sleep onset
3. Total sleep time
4. Pittsburgh Sleep Quality Index

§1.3State of the evidence

The Institute assesses 2 compounds in this indication, drawing on 2 trial records and 0 evidence syntheses. No compound is graded above low certainty in this indication, which the Institute records as the principal finding for it.^[1,2]

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
2. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.