Zolpimist Mouth Spray Insomnia Treatment OKed By FDA

Kathleen Blanchard's picture
Zolpimist Insomnia Treatmetn

NovaDel Pharma, Inc. has received approval from the FDA for the insomnia treatment drug containing the active ingredient found in Ambien. The drug Zolpimist, is delivered as a mouth spray, and is approved for insomnia treatment short-term. The drug contains Zolpidem, found in Ambien, one of the most popular drugs on the market used for the treatment of insomnia.

Steven B. Ratoff, Chairman of the Board and Interim CEO of NovaDel, says, "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. 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." Zolpidem is the second drug developed by the company as a mouth spray.

The drug is approved for use in those who has difficulty falling asleep, and should be taken immediately before going to bed.


Warnings about the insomnia treatment spray include avoidance of driving or operating heavy machinery the morning after using the insomnia spray. The company also warns of the possibility of sleepwalking, the same warning that comes with the oral drug Ambien. Other warnings include drug dependence, dizziness and headache.

Criteria for insomnia include difficulty falling asleep, or staying asleep. The mouth spray developed by the company is designed for rapid absorption when compared to conventional pills that are taken by mouth. Studies also show that drugs sprayed into the mouth are easier metabolized by the liver, as they are is eliminated from the body.

Other drugs for the treatment of angina, nausea, central nervous system disorders and migraine headache are also available as oral sprays. The company says using mouth sprays for drug delivery improves patient adherence and the inconvenience of swallowing a pill. Zolpimist for insomnia treatment is the newest addition.

The new mouth spray to treat insomnia is the latest addition to a multi-million dollar market for the treatment of insomnia. Sales of drugs for insomnia treatment are estimated to reach $3.8 billion by 2011.

SOURCE: NovaDel Pharma Inc.