FDA approves new drug for insomnia to be taken in middle of night

By Deborah Kotz , Globe Staff

The US Food and Drug Administration approved a low-dose sleeping pill today to treat insomnia that causes middle-of-the-night waking followed by a difficulty returning to sleep. Other higher-dose insomnia drugs are approved by the FDA to be taken before bedtime but Intermezzo (zolpidem tartrate), the name of the new drug, can be taken in the middle of the night.

That’s convenient for those who may want to wait before taking a bedtime sleeping pill until they know that their sleep has been irreversibly interrupted. About two to three million Americans visit doctors every year to get help for middle of the night wakenings. Up until now, many of them simply took higher dose sleeping pills when they woke -- a practice frowned upon by the FDA since it can cause extreme morning drowsiness.

Intermezzo should only be taken when a person has at least four hours of sleep remaining and hasn’t consumed any alcohol, according to the FDA.

A higher dose formulation of zolpidem tartrate (Ambien) has been on the market for nearly 20 years and used before bedtime to prevent insomnia. The drug has been available in cheaper generic versions for the past four years at a cost of about $2 to $3 a pill.

With a cost that hasn’t yet been determined, Intermezzo will be formulated in a 1.75 mg tablet dose for women and those over age 65 and 3.5 mg for men under 65, to be taken once per night, according to the FDA. (Men, women, and seniors metabolize the drug differently.) Ambien and its generic equivalents are typically formulated as 5 mg or 10 mg tablets.

While some doctors may simply prescribe 5 mg of generic Ambien -- telling patients to cut the pills in half -- that’s a messy method that may result in women getting too high a dose and men getting too small of one.

“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said Dr. Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research in a statement. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”

In two clinical trials involving more than 370 patients, those with middle of the night insomnia who took Intermezzo had a shorter time falling back asleep after waking compared to people taking a placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Like other sleep medicines, the FDA says Intermezzo may cause serious side effects, “including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.”

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.