New Insomnia Drug: New or Revised Version of an Old Generic?

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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Insomnia has a huge impact on people’s lives, with many relying on a medication for sleep. Sales of Ambien and Lunesta were over $3 billion in 2007. Ambien and Ambien CR then became available as generics (zolpidem and zolpidem er) so the hunt was on for new brand name insomnia medications, which are big money makers.

There is a new kid on the block for insomnia, but as it turns out it’s not so new. The insomnia drug Intermezzo has just been approved by the FDA for treatment of middle-of-the-night awakening.

What is Intermezzo?
Intermezzo is sublingual (dissolvable on the tongue) zolpidem. It is indicated for people who wake up in the middle of the night and want to get back to sleep immediately for a few hours. At this time, Intermezzo is the only prescription sleep medication indicated for dosing in the middle of the night.

How is it used?
– The recommended dose of Intermezzo is 1.75 mg for women and the elderly and 3.5 mg for men.

– It is taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep.

Intermezzo is not supposed to be taken when you have fewer than 4 hours of bedtime remaining before your planned time of waking.

How is it different from generic Ambien (zolpidem)?

The peak effect of Ambien and zolpidem 5 mg or 10 mg tablets is 90 minutes. The peak effect of Intermezzo (sublingual zolpidem) is 35 – 75 minutes. It is much shorter, meaning Intermezzo works faster. Is that worth the cost? You decide . . .

Dr O.

Intermezzo was approved by the FDA on November 23, 2011 and does not yet have a projected release date. As a new brand name drug, it will likely be expensive, possibly in the current range of Ambien ($90 – $180 for a 30-day prescription without insurance), and may not be covered by some insurance plans.

Update for clarification:

Intermezzo is a new shorter-acting sublingual form of zolpidem designed for quick onset of action (35 minutes), lasting about 2.5 to 3 hours.

Similarly, the generic version of Sonata (zaleplon) is also a short-acting sleep medication in the same class. The onset of action of zaleplon is 30 minutes, similar to Intermezzo, yet it lasts a little longer at about 4 hours. So if you took zaleplon when you woke up in the middle of the night, which is the approved indication for Intermezzo, you would need to have more than 4 hours of sleep left.

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