Vanda Pharmaceuticals Inc today announced the results of a HETLIOZ (tasimelteon) driving study to measure next day performance. Tasimelteon did not impair measures of driving performance, whereas the active control, zopiclone, showed significant impairment.
In this triple crossover study, 48 healthy volunteers drove 100 km in a validated driving simulator the morning after taking a bedtime dose of either tasimelteon 20 mg, zopiclone 7.5 mg, or placebo. The volunteers were instructed to operate the driving simulator for approximately 1 hour with a speed of 55 mph while maintaining lane position.
Treatment with tasimelteon 20 mg at bedtime demonstrated no next day driving impairment compared to placebo. Treatment with zopiclone 7.5 mg dosed at bedtime was associated with a meaningful and significant increase in standard deviation of lateral position (SDLP), a measure of lane weaving, compared to the placebo treatment.
A secondary analysis of the paired differences between treatments (a symmetry analysis) confirmed that tasimelteon did not impair next day driving while there was an impairment with zopiclone. A difference of 4.4 cm is considered equivalent to the driving impairment associated with a blood alcohol (BAC) level of 0.05%, a level associated with increased crash risk.
“Compared to other sleep agents where we’ve investigated next-day residual effects on driving, tasimelteon demonstrated no impairment when evaluated 9 hours after dosing,” says Gary G. Kay, PhD, president of Cognitive Research Corporation, the contract research organization who ran the study, in a release. Kay serves as a consultant for the National Highway Transportation Safety Administration (NHTSA) and is an expert in drug-impaired driving.
HETLIOZ is currently approved for the treatment of Non-24 Hour Sleep Wake Disorder. Vanda plans to file a supplemental new drug application for HETLIOZ for the treatment of jet lag disorder with the FDA in 2018. It is not currently approved by any regulatory authority for the treatment of jet lag.
Zopiclone is a non-benzodiazepine sleep agent marketed at a dose of 7.5 mg in countries outside the United States. In the US, eszopiclone the s-enantiomer of zopiclone, is available under the brand name Lunesta.