Pharmaceutical

FDA approves new prescription sleeping pill

Insomniacs now have a new prescription sleep aid option. After several rejections based on safety issues, Food and Drug Administration (FDA) has finally approved Intermezzo, a lower dose version of the prescription sleeping pill Ambien, for people who wake in the middle of the night and have trouble falling back to sleep.

Intermezzo (zolpidem tartrate siblingual tablets) was approved based on two clinical trails involving more than 370 patients, which found that patients who took the drug fell back to sleep faster than those who took a placebo. The most common side effects were headache, nausea and fatigue.

The recommended and maximum doses of Intermezzo are 3.5 milligrams for men and 1.75 milligrams for women, per night. The dosage for women is less because the drug takes longer to clear in women than men. The lower dosage compared to Ambien means there is less risk of a person having too much drug in his or her body upon waking, which can cause dangerous drowsiness and impaired driving.

The FDA’s approval of Intermezzo follows two previous rejections in 2009 and again in July 2011 due to concerns over potential side effects the following day, including the potential impact on driving.

Zolpidem, the active ingredient in Intermezzo, belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep. The siblingual tablets are to be placed under the tongue. The tablet should not be swallowed or taken with water.

Source: Your Life