Fentanyl, a synthetic opioid previously available for parenteral use in anesthesia (Sublimaze, and others) and in a transdermal patch for chronic pain (Duragesic - Medical Letter, 34:97, 1992), has now also been marketed as a raspberry-colored lozenge on a plastic handle (Fentanyl Oralet - Abbott), which resembles a lollipop. The new formulation will probably be promoted mainly for premedication of children before anesthesia, but has also been approved by the US Food and Drug Administration (FDA) for preanesthetic use in adults and for use in anesthesia or 'monitored anesthesia care' in...

The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due to middle-of-the-night awakening. Ambien and other zolpidem formulations available in the US are labeled for use only at bedtime.

Tramadol hydrochloride (Ultram - Ortho-McNeil), a centrally-acting analgesic marketed in Germany since 1977, was recently approved by the US Food and Drug Administration for oral treatment of moderate to moderately severe pain. Despite some opioid activity, tramadol has not been scheduled as a controlled substance.

The nicotine receptor partial agonist varenicline (Chantix - Pfizer) appears to be the most effective drug available to treat tobacco dependence, but the FDA has added a warning to the package insert about neuropsychiatric symptoms and exacerbations of preexisting psychiatric illness associated with its use. Agitation, hostility, depressed mood, suicidal ideation and suicidal behavior have been reported as postmarketing adverse events in patients who took varenicline and stopped smoking and in those who took the drug and continued to smoke.

The FDA has approved a buccal film formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Bunavail – BioDelivery Sciences) for maintenance treatment of opioid dependence. Sublingual tablet and film formulations of the same combination were approved earlier. The manufacturer of Bunavail claims that the new product is superior to sublingual formulations because of the convenience of buccal administration and better absorption into the blood, permitting use of lower doses.

Fentanyl, a synthetic opioid previously available for parenteral use in anesthesia (Sublimaze), has now been marketed in a controlled-release transdermal formulation (Duragesic - Janssen) for use in patients with chronic pain severe enough to require opioid analgesia. It is not recommended for treatment of postoperative pain because of the drug's slow onset and prolonged duration of action.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

Onapgo (Supernus), a solution for continuous subcutaneous infusion containing the dopamine agonist apomorphine, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Subcutaneously injected apomorphine (Apokyn, and generics) has been available for intermittent use for years. Vyalev, a foscarbidopa/foslevodopa solution for subcutaneous infusion, was approved in 2024 for the same indication.

Three nicotine-releasing adhesive patches for the skin (Habitrol - Ciba-Geigy; Nicoderm - Marion Merrell Dow; and PROSTEP - Lederle) have been approved by the US Food and Drug Administration to aid withdrawal from smoking. Nicotrol (Parke-Davis) may also be approved soon. All the manufacturers recommend using the patches in conjunction with a behavioral modification program.

Venlafaxine (Effexor, Effexor XR - Wyeth), an antidepressant that inhibits both norepinephrine and serotonin reuptake, was first approved by the FDA in 1993. It has been used mainly as a second-line agent for patients who have not responded to a selective serotonin reuptake inhibitor (SSRI). Some Medical Letter consultants have had the clinical impression that venlafaxine is more effective than an SSRI, particularly for patients with severe, classic depression (melancholia), and believe it should be considered a first-line drug (Treatment Guidelines from the Medical Letter 2003, 1:69). Is...