AMBIEN CR: renal conclusion is extrapolated from immediate-release data
What matters first
Product: Adult oral AMBIEN CR extended-release tablets. Not immediate-release or sublingual zolpidem; usual dosing and safety restrictions still apply.
- Renal action / finding
- Label: no renal adjustment; CR-specific renal study was not performed.
- Evidence or dialysis limit
- Not hemodialyzable does not supply a new supplemental-dose regimen.
- Monitoring / application
- Do not transfer the immediate-release study dose to CR; retain sedative safety restrictions.
- Product / population
- Adult oral AMBIEN CR extended-release tablets. Not immediate-release or sublingual zolpidem; usual dosing and safety restrictions still apply.
- Renal measure
- Renal conclusion supported by an immediate-release ESRD/hemodialysis study
- Source revision
- 08/2024
- Retrieved
- 2026-11-07 (not the revision date)
Not hemodialyzable does not supply a new supplemental-dose regimen.
Section 12.3, renal impairment; boxed warning context
The label states that renal dose adjustment is not necessary, but AMBIEN CR was not directly studied in renal impairment. The supporting study used immediate-release zolpidem in 11 patients with ESRD receiving hemodialysis. Zolpidem was not hemodialyzable. The historical immediate-release study dose is not a CR prescribing recommendation. Age, sex, hepatic status, next-day impairment and the boxed complex-sleep-behavior warning remain relevant despite the renal conclusion.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d934da3-bd77-4470-e063-6294a90a64f5
