Zaleplon

Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class

Recommendation (from TRS)

Summary
Zaleplon, chemical name 3¢-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)- N-ethylacetanilide, has not previously been reviewed by WHO. Zaleplon selectively binds to the brain alpha subunit of the GABAA omega-1 receptor. Its pharmacological properties are similar to those of zolpidem, and it is indicated for the short-term (2 to 4 weeks) management of insomnia. It produces a benzodiazepine-type with- drawal syndrome upon discontinuation of long-term use and studies on subjective effects show its similarity to triazolam. Zaleplon has been on the market for only a short time and the number of reports of abuse-related adverse drug reactions received by the international drug monitoring programme are as yet very few.

Recommendation
Although the abuse potential of this substance is considered to be similar to that of zolpidem and triazolam, critical review was not recommended at this stage as the information on actual abuse avail- able to the Committee was insufficient to confirm the existence of significant public health and social problems in more than one coun- try. However, the Committee recommended that WHO continue the surveillance of zaleplon1.

ECDD Recommendation

Recommended for surveillance at 33rd ECDD (2003) Although the abuse potential of this substance is considered to be similar to that of zolpidem and triazolam, critical review was not recommended at this stage as the information on actual abuse available to the 33rd Committee was insufficient to confirm the existence of significant public health and social problems in more than one country. However, the 33rd Committee recommended that WHO continue the surveillance of zaleplon.