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The physiological effects of zolpidem in people with obstructive sleep apnoea

The effects of zolpidem on OSA severity

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001287224
Acronym
ZolpidemOSA
Enrollment
20
Registered
2018-07-31
Start date
2018-07-31
Completion date
2019-07-10
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this physiology study is to determine the effects of zolpidem (10mg) on obstructive sleep apnoea severity, upper airway muscle activity, the respiratory arousal threshold and breathing parameters during sleep.

Interventions

Standard dose of zolpidem (10mg, oral tablet), each participant to receive zolpidem once, immediately before bed. Zolpidem to be taken orally in front of the investigator for these single-night, acute in-laboratory studies. 1 week washout between visits.

Sponsors

Neuroscience Research Australia (NeuRA)
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

Otherwise healthy, men and women with obstructive sleep apnoea Patients who have a low-moderate respiratory arousal threshold (between zero and -25cmH2O epiglottic pressure just prior to arousal) as estimated from their baseline sleep study.

Exclusion criteria

Patients with confirmed overnight blood oxygen saturation nadir (SaO2) less than 70% from baseline sleep study Patients who are estimated to have a high arousal threshold (less than -25cmH2O epiglottic pressure prior to arousal) Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. -Patients with any other medical condition which may interfere in the evaluation of the study. -Patients with a previous history of addiction to alcohol or drugs. -Patients taking medications known to affect sleep or muscle activity.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026