Reaffirming the notion that there is indeed a pill for every ill, on November 23rd of this month the US Food and Drug Administration 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.

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 or misuse 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 not be helped by this drug given 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. They’re married to the medication, so guidelines be damned.

There are too many variables associated with the sleep-wake cycle to micromanage   insomnia. Intermezzo® is a bad idea because the drug is ripe for manipulation. Also, for some people, broken sleep may actually be natural sleep.