Women more sensitive than men to sublingual zolpidem

Women more sensitive than men to sublingual zolpidem

(HealthDay)—Clearance of zolpidem (administered as a sublingual tablet; ZST) is lower in females compared to males, according to a study published in the March issue of The Journal of Clinical Pharmacology.

David J. Greenblatt, M.D., from the Tufts University School of Medicine in Boston, and colleagues evaluated the effect of dose and gender on the pharmacokinetics (PK) and pharmacodynamics (PD) of zolpidem in healthy nonelderly male and female volunteers (11 and 13 males). Participants received a single morning dose of ZST (1.0, 1.75, and 3.5 mg) or placebo.

The researchers found that, in male and female subjects, ZST PK were linear, with area under the curve (AUC) proportional to dose. Oral clearance and elimination half-life was independent of dose; however, in females, the AUC averaged 40 to 50 percent higher, compared to males receiving the same dose. Body weight incompletely explained the gender effect. In females, particularly at the 3.5-mg dose, ZST produced PD changes consistent with benzodiazepine agonist effects. PD effects were significantly related to plasma zolpidem concentrations for several PD variables when data were aggregated across subjects, although there was variability in individuals' response. Regardless of plasma concentration, PD effects of zolpidem seldom differed from placebo in men.

"PD effects of zolpidem from ZST are greater in female subjects, due to a combination of higher plasma concentrations and greater intrinsic sensitivity," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Transcept Pharmaceuticals, which funded the study and is a manufacturer of .

More information: Abstract
Full Text

add to favorites email to friend print save as pdf

Related Stories

US approves drug for middle-of-the-night insomniacs

Nov 23, 2011

The US Food and Drug Administration, for the first time, approved Wednesday medication specifically designed for those who wake up in the middle of the night and cannot fall back to sleep.

FDA: lower ambien's dose to prevent drowsy driving

May 15, 2013

(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...

FDA requires lower doses for sleep medications (Update)

Jan 10, 2013

(HealthDay)—The U.S. Food and Drug Administration announced Thursday that it is asking manufacturers of sleep medications containing zolpidem—including Ambien—to lower the recommended doses and to provide ...

Recommended for you

A new tool in drug overdose prevention

3 hours ago

The Center for Disease Control reported earlier this month that the heroin overdose death rate across 28 states it surveyed doubled between 2010 and 2012. This sharp increase and the chilling statistics that say more than 11 ...

Nasal spray treats heroin overdose

Oct 28, 2014

"Every year, drug overdoses are responsible for roughly 1000 ambulance calls in Oslo," says Arne Skulberg, an anaesthesiologist, a PhD candidate at NTNU and the 2014 winner of Norway's Researcher Grand Prix ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.