New indication: FDA approved Zolpidem tartrate sublingual tablets or the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep.
On November 23, 2011, FDA approved zolpidem tartrate sublingual tablets for the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep. Zolpidem is a GABAA agonist that acts as a hypnotic agent by selectively binding to BZ1 receptors.
Efficacy. Sublingual zolpidem's efficacy was established in 2 randomized, double-blind, placebo-controlled trials in patients characterized with difficulty returning to sleep after MOTN wakening. In an 82-adult participant (aged 18 to 64 years) sleep-laboratory study using 1.75- and 3.5-mg scheduled doses of sublingual zolpidem or placebo, participants assigned to zolpidem realized significantly shortened sleep latency as measured by objective (polysomnography) and subjective (patient-estimated) measures compared to placebo. Of note, sublingual zolpidem's effect on sleep latency was similar for females receiving the 1.75-mg and males receiving the 3.5-mg dose. In a second 4-week study of 295 patients in a similar population but using as needed (PRN) dosing, sublingual zolpidem 3.5 mg again significantly shortened the patient-estimated time to fall back to sleep after MOTN wakening compared to placebo.
Safety. The safety of sublingual zolpidem was evaluated during the same 2 double-blind, placebo-controlled trials of adult patients. Combined, these trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of sublingual zolpidem, respectively. The most common adverse events (occurring in >1%) during clinical trials included headache, nausea, and fatigue. Zolpidem is a central nervous system (CNS) depressant and may impair alertness, motor function, and respiratory function. Consequently, driving and other complex motor functions may be impaired due to zolpidem. "Sleep-driving" and other complex behaviors while not fully awake may occur, and this risk increases with higher doses and/or coadministration with other CNS depressants (eg, alcohol). Zolpidem use may worsen depression or result in suicidal thinking. Patients should be re-evaluated within 7 to 10 days to determine any comorbid diagnosis to insomnia and any adverse reactions that may have occurred because of zolpidem administration.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.