The Food and Drug Administration has approved NovaDel Pharma Inc.’s Zolpimist for the short-term treatment of insomnia.

 

The approval was given based on data from two randomized studies in which Zolpimist was compared to Ambien tablets in young and elderly healthy volunteers.

 

“We believe the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” commented Steven B. Ratoff, Chairman of the Board and Interim CEO of NovaDel.

 

Zolpimist is an oral spray that contains zolpidem tartrate, the same active ingredient found in the widely used prescription sleep aid Ambien. The substance is absorbed through the oral mucosa directly into systemic circulation. According to NovaDel, the most commonly observed side effects in clinical trials were headache, sleepiness and dizziness.

 

Zolpimist was approved in 5-milligram and 10-milligram strengths. It should be taken “immediately before bedtime and users should be prepared to get a full night’s sleep of seven to eight hours,” NovaDel said in a news release.

 

Cautions that apply to other prescription sleep aids also apply to Zolpimist. The company cautions patients to avoid engaging in any activities that require full alertness, such as driving or operating hazardous machinery the morning after taking any sleep medication. Also people taking such drugs should see a doctor if they experience any unusual changes in thinking or behavior. For full prescribing information, including the FDA medication guide and patient instructions for use, please visit www.novadel.com.

 

Zolpimist is NovaDel's second product approved by the FDA that uses NovaDel's proprietary NovaMist oral spray technology.