ZolpiMist™ is a US FDA approved, patented, cherry-flavoured, oro-mucosal spray formulation of zolpidem tartrate (marketed as tablets under the brand name of Ambien or Stilnox). Zolpidem tartrate is a non-benzodiazepine prescribed for the short-term treatment of insomnia characterised by difficulties with sleep initiation, as per Ambien’s approved indication. In July 2020, ZolpiMist was approved by the Therapeutics Goods Administration (TGA). Once listed on the Australian Register of Therapeutics Goods (ARTG), ZolpiMist can be commercialised throughout Australia.
ZolpiMist provides a convenient and easy-to-use alternative route of administration, by delivering a therapeutic dose with one or two actuations of the spray into the oral cavity.
ZolpiMist advantages may include reduced sleep patient convenience, and ease of use as it is administered without the need of water, unlike conventional tablets. Additionally, it may be used in patient populations experiencing difficulties in swallowing and/or suffering with gastrointestinal (GI) disorders that restrict the absorption of drugs via the GI mucosa.
Partners / agreements
SUDA has exclusive license agreements with:
- Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries Limited for Brazil, Mexico and Chile.
- Mitsubishi Tanabe Pharma Singapore, a subsidiary company of Mitsubishi Tanabe Pharma for Singapore, Malaysia and the Philippines.
- Mitsubishi Tanabe Pharma Korea, a subsidiary company of Mitsubishi Tanabe Pharma, for South Korea