Request Not To Control Suvorexant
One commenter opposed controlling suvorexant because they believed that there was a lack of strong scientific evidence that suvorexant has been abused, and the comparison of suvorexant with zolpidem (schedule IV) is incorrect due to each compound eliciting its effects via different mechanisms of action. The commenter was also concerned that controlling suvorexant will make it more difficult for patients to obtain the substance once it is approved by the FDA.
DEA Response: The DEA does not agree. Suvorexant is a novel, first in class, new chemical substance and information on actual abuse data is not currently available. The legislative history of the CSA addresses the assessment of a new drug's potential for abuse,\2\ and data from clinical studies investigating the abuse potential for suvorexant suggests that its effect is similar to zolpidem (schedule IV). Similarly, while the mechanism of action for suvorexant is distinct from any currently marketed drug for insomnia, human abuse potential studies demonstrated that suvorexant produced effects that were indistinguishable from zolpidem (schedule IV).