Semax in sleep initiation and maintenance disorders — evidence extract
No eligible study has been identified for Semax in sleep initiation and maintenance disorders. The Institute records the question as not assessed and states what would change that.
§1Evidence extract: Sleep initiation and maintenance disorders
§1.1Question and anchor outcome
- Population
- Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.
- Intervention
- Semax, intranasal in the approved russian presentations; also supplied for subcutaneous use
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Sleep-onset latency
Additional outcomes the Institute extracts for this indication: Wake after sleep onset; Total sleep time; Pittsburgh Sleep Quality Index.
§1.2Contributing trials
No trial has been identified for Semax in sleep initiation and maintenance disorders. No certainty rating is issued where that is so, for the reason given at §1.3.
§1.3Why no certainty rating is issued
The Institute rates certainty in a body of evidence. Where no eligible study has been identified there is no such body, and the domain-by-domain assessment used elsewhere in this series is not rendered: an inconsistency judgement requires two estimates to be inconsistent with one another, and an imprecision judgement requires an interval. Neither exists here.
The outcome is therefore recorded as not assessed. It is listed in the certainty index under that heading rather than at the lowest rating, because a rating of very low certainty says that evidence was found and is weak, and that is not what has happened.
What would change this: a controlled study in the population stated at §1.1, reporting the anchor outcome, retrievable in a form the Institute can appraise. The evidence gaps recorded in the monograph at §9 state what such a study would need to measure.
§1.4What this extract does not establish
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.
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