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Insomnia: A Short Review

Insomnia occurs in most people at some time in their life, even if only briefly. But 20%-50% of people have insomnia on a regular basis. Current treatments have focused on behavioral therapies aimed at reducing lifestyle factors that exacerbate or precipitate insomnia and pharmacologic treatments to settle the sleep disturbance once it has occurred. Most sleeping pills, hypnotics, have been developed to be taken at or before bedtime with the aim of promoting sleep for the approximately 8 hours that most people require. However, we recognize that many people are able to fall asleep without difficulty but then unexpectedly awaken during the night and are unable to return to sleep. Approximately 35% of people have middle-of-the-night (MON) awakenings at least 3 nights per week.

Enter, Intermezzo

Intermezzo®, sublingual low-dose zolpidem tartrate, is a hypnotic that has been developed especially for people who have MON awakenings and who have at least 4 hours remaining to sleep. Most hypnotics are not approved for MON awakenings as they have doses or half-lives that could cause sedation around the time of awakening at the end of the sleep episode and therefore could impair alertness and be hazardous to activities such as driving. The newer hypnotics that are specific for the benzodiazepine receptors that promote sleep, the so-called non-benzodiazepine receptor agonists, such as zolpidem, zaleplon, and eszopiclone, are the most commonly prescribed hypnotics for insomnia. Two other relatively new hypnotic medications, ramelteon, a melatonin agonist, and low-dose doxepin, an antihistamine antidepressant medication, are also approved for insomnia but not for MON insomnia.

Zolpidem tartrate is approved by the US Food and Drug Administration in doses of 5 mg or more as Ambien®, Ambien CR®, Zolpimist™, Edluar™, and zolpidem generics, but only Intermezzo, which has a half-life of approximately 2.5 hours, is FDA approved for MON awakenings. Intermezzo is formulated in a sublingual, rapidly absorbed form at doses of 1.75 mg and 3.5 mg.

The Evidence and Therapeutic Role

Studies of Intermezzo in insomnia patients who are permitted to take the medication up to 7 nights per week have found that patients only needed the medication 5 nights a week for the first week and 4 tablets per week by the fourth week. Only 18% needed the medication nightly by the fourth week. The time to fall back to sleep, latency to persistent sleep, total sleep time, ratings of sleep quality, and level of refreshed sleep have been shown to be significantly improved compared with placebo when taken 4 hours after lights out at night. Adverse effects were mild and transient, with headache and nausea being the most common, and no adverse effects were seen on the mucosa of the mouth.

The dosing of Intermezzo is different in men vs women, as women tend to have higher serum concentrations than men. The 1.75-mg dose is recommended for women and 3.5-mg dose for men. Because the time of taking the medication may vary from patient to patient it is recommended that patients have at least 4 hours remaining for sleep.

Intermezzo is likely to be a well-received hypnotic by most people who have either MON awakenings or who have only 4 or more hours available for sleep.

Medscape Neurology © 2011 WebMD, LLC