MONDAY, Dec. 22, 2008 (HealthDay News) -- NovaDel Pharma's Zolpimist (zolpidem tartrate) oral spray has been approved by the U.S. Food and Drug Administration for short-term treatment of insomnia, the drug's maker said Monday.
Approved in 5-milligram and 10-milligram strengths, the spray contains the same active ingredient as the widely used
prescription sleep aid Ambien.
Approval for Zolpimist was given based on data from two randomized studies in which Zolpimist was compared to Ambien tablets in young and elderly healthy volunteers.
Zolpimist 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.
Some people who have taken this type of drug, called a sedative hypnotic, have reported unusual cases of sleepwalking, including driving or eating, while not fully awake, the company said. While sedative hypnotics are not narcotic, they do have some risk of dependency. The most common side effects observed in clinical testing of Zolpimist were headache, drowsiness and dizziness.
More information
The National Heart Lung and Blood Institute has more about this condition.
