Oral Spray Sleep Drug Zolpimist Approved
Zolpimist Approved for Short-Term Treatment of Insomnia
Dec. 22, 2008 -- The FDA has approved a prescription oral spray called Zolpimist, which contains the sleep drug Ambien's active ingredient, for the short-term treatment of insomnia brought on by difficulty falling asleep.
NovaDel Pharma Inc., the drug company that makes Zolpimist, issued a news release today announcing the FDA's approval. An FDA spokesperson wasn't immediately available for comment.
NovaDel states that oral sprays may work faster than tablets and "eliminate the requirement for water or for the need to swallow, potentially improving patient convenience and adherence," and that Zolpimist is "bioequivalent" to Ambien tablets.
Because Zolpimist works rapidly, patients should take it "immediately before bedtime and be prepared to get a full night's sleep (7-8 hours)," states NovaDel's news release.
According to NovaDel, the most commonly observed side effects in clinical trials of Zolpimist were headache, sleepiness, and dizziness.
Cautions that apply to other prescription sleep aids apply to Zolpimist.
For instance, NovaDel cautions patients to "use extreme care in or avoid engaging in any activities requiring full alertness, such as driving or operating hazardous machinery the morning after taking any sleep medication," and to see a doctor if they experience any "unusual changes in thinking or behavior" while using Zolpimist.