ReGen's zolpidem non-sedating in antidormancy trial

UK-based biotechnology firm ReGen Therapeutics says that data from a study of its novel formulation of zolpidem indicate that the drug is non-sedating. The firm explained that the assessment had been designed to examine the antidormancy effects of the drug in conscious, fully-perceptive ambulant patients who have various disabilities as a result of brain damage.

The drug, which is an off-patent sedative that was formally marketed by French drug major Sanofi-Aventis under the brand names Stilnox and Ambien (Marketletters passim), was examined in a Phase II placebo-controlled study at sites in the UK and South Africa, where its antidormancy effect was first identified.

The results showed that the 2.5mg dosage, delivered in the form of a sublingual spray, was no more sedating than placebo, while the 5mg and 10mg formulations were sedative in a dose dependant manner. The trial also demonstrated that the spray version of the product had a faster onset of action than tablet versions of the drug.