A new formulation of the insomnia drug zolpidem tartrate (Ambien) has been approved with a lower dosage, and with a different brand name, to treat middle-of-the-night awakenings followed by difficulty returning to sleep, the FDA said.
Called Intermezzo, the sublingual tablet product has a maximum recommended dose of 1.75 mg for women and 3.5 mg for men, to be taken once per night. The gender difference stems from slower clearance rates in women, according to the FDA.
In contrast, the standard Ambien dose is 10 mg.
"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 Robert Temple, MD, 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."
The agency said the low-dose formulation was evaluated in two clinical trials with more than 370 patients. Patients taking the low-dose drug had shorter sleep latency after awakening compared with placebo. The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue.
As with other sleep medications, the product may lead to somnambulation, risk of which is increased when it is combined with alcohol or other sedative drugs.
The new formulation is manufactured by Transcept Pharmaceuticals of Port Richmond, Calif.