Reaffirming the notion that there is indeed a pill for every ill, the U.S. Food and Drug Administration has approved Intermezzo® (zolpidem tartrate sublingual tablets) for use as needed for the management of insomnia associated with middle-of-the-night awakenings and difficulty returning to sleep. This is the first time the FDA has approved a drug specifically for this indication. The agency warns that Intermezzo® should be used only when there are at least four hours of bedtime remaining.

The word intermezzo is a term from the musical world – particularly opera – and is defined as a “brief interlude.” This is actually a clever brand name for the drug as per its usage indication outlined above; but it’s also a dicey concept beckoning misuse.

Here’s a quick refresher if you’re not familiar with generic names. Zolpidem tartrate is Ambien®. And sublingual administration allows for rapid absorption into the blood stream when placed under the tongue. The recommended and maximum doses of Intermezzo® are 1.75mg for women and 3.5mg for men. The recommended dose is lower for women because women excrete zolpidem at a slower rate compared to men.

When it comes to sleep difficulties, if there’s a way to mismanage a medication, some people will find it. My concerns regarding Intermezzo® use are as follows:

  • Some users will ignore the indications and use this drug to help them get to sleep. Why not do so? If the drug helps reinitiate sleep after awakening, why wouldn’t it help someone get to sleep in the first place? The problem with taking it to get to sleep is that upon awakening in the middle of the night people will repeat the dose. This is a no-no.
  • Folks who awaken more than once during the night, say every two hours or so, would likely exceed the maximum dosage recommendations above.
  • Those who use regular 5mg or 10mg Ambien® at bedtime and also experience middle-of-the-night awakenings could easily become confused with what dose they’re taking and when – if they also use Intermezzo®. And this will happen, because some prescribers will issue prescriptions for both to the same person.
  • The warning regarding use at least four hours before arising as planned will be violated. Optimally, if one is scheduled to rise at 7am, Intermezzo® shouldn’t be used after 3am. Those who count on a pill to promote or maintain sleep will ignore time frames; it’s that simple.

There are too many variables associated with the sleep-wake cycle to micromanage insomnia. Intermezzo® is a bad idea because the drug is rife for manipulation.

Also, for some people, broken sleep may actually be natural sleep.

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Joe Wegmann is a licensed clinical social worker and a clinical pharmacist with over 30 years of experience in counseling and medication treatment of depression and anxiety. Joe’s new book, www.pesi.com. To learn more about Joe’s programs or to contribute a question for Joe to answer in a future article, visit his website at www.thepharmatherapist.com, or e-mail him at joe@thepharmatherapist.com.