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Table 5 GRADE evidence profile

From: Efficacy and safety of Z-substances in the management of insomnia in older adults: a systematic review for the development of recommendations to reduce potentially inappropriate prescribing

Certainty assessment

№ of patients

Effect

Certainty

Importance

№ of studies

Study design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerations

BDLM

Placebo

Relative (95% CI)

Absolute (95% CI)

Mortality

0

        

not estimable

 

CRITICAL

Hospitalization (timing of exposure: 30 days; assessed with: number of cases with hospitalization for traumatic brain injury and hip fractures)

3 (80–82)

observational studies

      

CRITICAL

Quality of life (Eszopiclone vs. placebo) (follow up: mean 12 weeks; assessed with: SF-36)

1 (66)

randomized trials

serious a

not serious

not serious

not serious

none

194

194

mean 71.6 higher (0 to 0)

MODERATE

CRITICAL

Accidental event (follow up: mean 3 months; assessed with: events)

1 (83)

observational studies

not serious

not serious

not serious

not serious

none

440/156,987 (0.3%)

0.5/988 (0.1%)

OR 2.77 (CI95 0.38 to 19.76)

1 more per 1000 (from 0 fewer to 9 more)

HIGH

CRITICAL

Hip fracture with Zolpidem (timing of exposure: range 1 day to 180 days; assessed with: events)

3 (78, 81, 82)

observational studies

not serious

not serious

not serious

not serious

none

4307 cases 17,115 controls

OR 1.50 (CI95 0.96 to 2.34)

HIGH

CRITICAL

Any fracture with Zolpidem (timing of exposure: mean 1 day; assessed with: events)

2 (76, 79)

observational studies

not serious

not serious

not serious

not serious

none

7518 cases 30,072 controls

OR 1.22 (CI95 1.01 to 1.48)

HIGH

CRITICAL

Falls (timing of exposure: mean 1 day; assessed with: events)

1 (75)

observational studies

serious b

not serious

not serious

not serious

none

165 cases 165 controls

OR 2.38 (CI95 1.04 to 5.43)

MODERATE

CRITICAL

Effect “well-rested” (follow up: 12 weeks; assessed with: sleep quality 11-point Likert scale Eszopiclone 2 mg vs placebo; Scale from: 0 to 11)

1 (73)

randomized trials

     

79

80

SMD 7.1 SD higher (0 to 0)

CRITICAL