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Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg

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Abstract

Rationale

Alprazolam extended-release (XR) is approved for the treatment of panic disorder. This sustained formulation is absorbed in a delayed manner and is therefore expected to produce fewer and less severe side effects than its immediate release equivalent (alprazolam IR). The effect of alprazolam XR on potentially dangerous daily activities, such as driving a car, is expected to be less as compared to alprazolam IR.

Objectives

The present study was designed to compare the effects of alprazolam XR (1 mg) and alprazolam IR (1 mg) on actual driving ability and cognitive function.

Method

Eighteen healthy volunteers (aged 20–45 years) participated in a double-blind, placebo-controlled, three-way crossover study. At 4 h post-dose, subjects performed a standardized driving test on a primary highway in normal traffic. Cognitive and psychomotor tests were assessed 1, 2.5, and 5.5 h post-dose. Memory functioning was measured only 1 h after administration.

Results

Both formulations severely impaired driving performance between 4 and 5 h after administration. The magnitude of impairment in the driving test observed with alprazolam XR was about half that observed with alprazolam IR. Laboratory test results were in line with the driving data.

Conclusions

The acute impairing effects of alprazolam XR 1 mg on driving and psychomotor functions were generally less, as compared to its immediate-release equivalent, but still of sufficient magnitude to increase the risk of becoming involved in traffic accidents.

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Acknowledgment

This research was supported by a grant from Pfizer, New York, USA.

We like to thank Anita van Oers, Janneke Guijaux, Roland Otten, Henk Brauers, Willy Jeurissen, Irma Brauers and Cees van Leeuwen for their assistance in data collection.

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Authors and Affiliations

  1. Experimental Psychopharmacology Unit, Brain and Behavior Institute, Faculty of Psychology, Maastricht University, Maastricht, The Netherlands

    Tim R. M. Leufkens, Annemiek Vermeeren, Peter van Ruitenbeek & Johannes G. Ramaekers

  2. Department of Toxicology, The Netherlands Forensic Institute (NFI), The Hague, The Netherlands

    Beitske E. Smink

  3. Department of Neurocognition, Faculty of Psychology, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands

    Tim R. M. Leufkens

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  1. Tim R. M. Leufkens
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  2. Annemiek Vermeeren
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  3. Beitske E. Smink
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  4. Peter van Ruitenbeek
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  5. Johannes G. Ramaekers
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Correspondence to Tim R. M. Leufkens.

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Leufkens, T.R.M., Vermeeren, A., Smink, B.E. et al. Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg. Psychopharmacology 191, 951–959 (2007). https://doi.org/10.1007/s00213-006-0669-8

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  • DOI: https://doi.org/10.1007/s00213-006-0669-8

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