Thin-film Way To Better Sleep

Now here is a question for you. When you reach for a tablet of Ambien, do you have performance anxiety — in the nicest possible sense of the words, of course? It seems that a number of people are finding it difficult to swallow their Ambiens (and others medications). In some, this is a psychological problem. Because the patient resents the idea of being medicated, the resistance is increasingly demonstrated through an inability to swallow the “offending” pills. In others, it is a taste issue. Even though the tablet may only be on the tongue for a few seconds, this is enough to trigger a gagging response. Unfortunately, manufacturers make an effort to flavour medications which are in a liquid form, but only rarely do so when they expect the pill or capsule to be swallowed.

There are also people whose underlying conditions may make swallowing more difficult or whose digestive systems may react adversely to the medications. For example, if you need to give a medication to either an autistic child or one who is hyperactive, actually getting a swallowing response may be challenging. For different reasons, if you already have an anxiety or panic condition, you may be predisposed to find some physical activities more alarming or be unable to swallow during an attack. If you have reduced saliva, or problems with your throat, the physical action of swallowing anything may be difficult even if you attempt to wash down solids.

In some cases, it may be safe to crush the tablet and to mix the resulting powder with a strongly flavoured drink or puree (this is not recommended with Ambien, particularly in Ambien CR extended-release form, because it can release too much of the active ingredients into your blood stream too quickly). Obviously crushing overcomes the problem of swallowing a physical object, but it may not solve the problems of taste. Some people can still taste an unusual flavour in any masking medium.

So here comes US-based MonoSol which acquired the technology from Kosmos Pharma in January 2004, and now specialises in the development of edible film strips which are designed to dissolve quickly on the tongue to deliver the medication. The film strips look like postage stamps and they are already used both in and cold remedies, and in breath-freshening strips. The delivery system is more convenient than using liquids which can be spilled, and more easily administered as a pleasant-tasting lozenge to improve

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patient compliance. Unlike some other dissolving systems, the MonoSol film is not fragile.

MonoSol is currently working to complete development of a film delivery system for Ambien. The physical development work is now complete, and the company is currently conducting a pilot trial of a thin-film version of Ambien to establish that this system delivers a dose that is the bioequivalent to the tablet form. The company expects a successful outcome — it has already successfully tested a version of Zofran, an antiemetic used post-surgery and in cancer therapy. The only difficulty arises from the financial climate. MonoSol has just cancelled an IPO intended to raise around $65m to fund research and development. Nevertheless, it is expected to continue development of the current projects including Ambien.

So if you are finding it difficult to swallow your Ambien, relief may be on the way. There is only one final thought. Ambien currently works to induce sleep in around fifteen minutes. Dissolving systems work rather more quickly. If you do decide to use the film system when it arrives on the market, make sure you are lying down when you take your first Ambien film.