New insomnia medication approved by FDA

Flemington, United States, December 22: The Food and Drug Administration (FDA) yesterday sanctioned approval to the Novadel Zolpimist, an oral spray for short-term treatment of insomnia.

The approval was based primarily on data based studies comparing it to Ambien, a popular sleeping pill used by both young and old for sleep disorders. The study compared the safety of spray vs. tablets.

There was an assessment of drug concentration, exposure, absorption and level of sedation. The main ingredient, zolopiderm tartrate, in the spray was the same as the one used in Ambien. The results demonstrated a bioequivalence between Zolpimist and Ambien.

Steven B Ratoff, Chairman of NovaDel, stated, “We believe the FDA Approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa.

“This achievement is another major milestone for NovaDel as it further validates our ability to develop innovative drugs based on the NovaMist technology. We are actively seeking a partner to commercialize this innovative product and believe that this approval should enhance those efforts.”

Clinical studies reveal that a low dose of Zolpimist is effective in treating insomnia patients who wake up during the night and have difficulty falling back asleep. NovaDel suggests the oral spray as it works faster and can "eliminate the requirement for water or for the need to swallow, potentially improving patient convenience and adherence.”

Because of its quick action the usage is recommended just before bedtime for a stretch of undisrupted sleep for seven to eight hours. The commonly linked side effects of Zolpimist are nausea, sleepiness and headache.

NovaDel warns 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." They also advise consultations with a doctor if "unusual changes in thinking or behavior" persist while using Zolpimist.

Insomnia is a sleeping disorder characterized by difficulty in falling asleep or maintaining asleep. It is typically followed by functional impairment while awake. Insomniacs have been known to complain about being unable to close their eyes or "rest their mind" for more than a few minutes at a time. They tend to wake up early and often complain of disturbed sleep.

According to the U.S. Department of Health and Human Services, in 2007, approximately 64 million Americans suffered from insomnia. Nearly 14 percent required some sleep related aid.