Sublingual Zolpidem tartrate lozenge for the treatment of insomnia

摘要

Sublingual Zolpidem tartrate (SZT) is a sublingual lozenge containing a low dose of the nonbenzodiazepine hypnotic Zolpidem tartrate. Pharmacokinetic evaluations suggest that this formulation produces higher drug plasma levels within the first 15-20 min after dosing than the standard oral tablet using only approximately 30% of the standard dose. Published data suggest that SZT is generally safe and effective at rapidly inducing sedation without residual next-day effects, as long as the patient has at least 4 h remaining in bed at the time of administration. SZT is currently being reviewed by the US FDA for potential approval for insomnia characterized by middle-of-the-night awakenings with difficulty returning to sleep.