STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.
The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.
"In this outpatient pivotal trial, patients taking Intermezzo reported significantly reduced time to return to sleep than those taking placebo, which confirms that patients who wake in the middle of the night and have difficulty returning to sleep have an important treatment option to consider," study author and director of the Sleep Disorders and Research Center at Detroit's Henry Ford Hospital Thomas Roth said.
Patients in the study were randomized to receive 3.5 mg of Intermezzo or placebo, and while all the patients took the 3.5 mg dose, only the 1.75 mg dose has the FDA's approval for use in women, the company said. Over four weeks, the drug "significantly" reduced patient-estimated latency to sleep onset following middle-of-the-night awakenings compared with placebo, the study found.