Oral Spray Form of Zolpidem Approved for Short-Term Insomnia Treatment

Laurie Barclay, MD

December 23, 2008

December 23, 2008 — NovaDel announced yesterday that the US Food and Drug Administration (FDA) has approved an oral spray formulation of zolpidem tartrate (Zolpimist) for the short-term treatment of insomnia characterized by difficulty with sleep initiation.

The oral spray, which is available in 5- and 10-mg dosing strengths, allows for fast absorption through the oral mucosa of zolpidem, which is also the active agent in Ambien (sanofi-aventis), currently the most prescribed sedative hypnotic worldwide for treatment of insomnia.

"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," Steven B. Ratoff, chairman of the board and interim CEO of NovaDel, said in a news release.

Findings supporting the FDA approval came from 2 randomized, open-label, dose-ranging studies showing bioequivalence between Zolpimist spray and Ambien tablets in young and elderly healthy volunteers. These studies compared the pharmacokinetics and safety of comparable doses of zolpidem given by oral spray or in tablets. Outcome measures included maximum drug concentration (C max), total exposure to drug (area-under-the-curve/AUC0-inf), speed of drug absorption, and level of sedation achieved. NovaDel also submitted to the FDA data from process validation and registration stability batches manufactured at the intended commercial facility.

Because of the rapid onset of action of the oral spray formulation of zolpidem, it should be taken immediately before bedtime on nights when patients can get a full night's sleep (7 – 8 hours). Patients should use extreme caution or completely avoid driving, operating hazardous machinery, or other activities requiring full alertness on the morning after taking any sleep medication. Medications for insomnia should not be taken with alcohol.

In controlled clinical trials, the most commonly observed adverse effects were headache, somnolence, and dizziness. Use of sedative hypnotics may result in complex behaviors including somnambulism — driving or eating while not fully awake — with amnesia for the event. Severe allergic reactions may also occur. Patients who experience such events should immediately contact their physician, discontinue use of the drug, and not be rechallenged.

The oral spray formulation of zolpidem tartrate is intended for short-term use, and prolonged use of any sedative hypnotic should be avoided without first consulting a physician. Patients with unusual changes in thinking or behavior or with persistent sleep problems should also consult their physician, because these problems may suggest another medical condition. Although sedative hypnotics are nonnarcotic, there is some risk for dependency.

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