Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has approved Intermezzo® (zolpidem tartrate sublingual tablet) C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Middle-of-the-night awakening with difficulty falling back to sleep is a form of insomnia that is estimated to affect millions of adults in the United States.1 Intermezzo is the first and only prescription sleep aid indicated for dosing in the middle of the night to treat this form of insomnia.
Intermezzo is formulated as a sublingual tablet containing a bicarbonate-carbonate buffer. Intermezzo is rapidly absorbed in both women and men. The recommended dose of Intermezzo for non-elderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. These recommended doses are specific to each gender because women clear zolpidem from the body at a lower rate than men. The 1.75 mg dose is recommended for patients over the age of 65. The recommended doses of other FDA approved zolpidem products range between 5 mg and 12.5 mg and are indicated for bedtime use.
The safety and efficacy of Intermezzo were evaluated in two placebo-controlled studies for the treatment of patients with insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. In both a sleep laboratory study and an outpatient study, treatment with Intermezzo after a middle-of-the-night awakening helped patients return to sleep significantly faster than placebo. The most commonly reported adverse reactions in these studies were headache, nausea and fatigue.2
Transcept has agreed to FDA post-marketing commitments including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment in accordance with the Pediatric Research Equity Act (PREA).
Transcept and Purdue are parties to a collaboration agreement for the development and commercialization of Intermezzo in the United States. Under this collaboration agreement, Purdue has until December 8, 2011 to notify Transcept whether it will proceed with the commercialization of Intermezzo.
About IntermezzoIntermezzo® (zolpidem tartrate sublingual tablet) C-IV is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Intermezzo is formulated as a sublingual tablet that contains a bicarbonate-carbonate buffer and is intended to be placed under the tongue where it is allowed to disintegrate completely before swallowing. Intermezzo is available in doses of 1.75 mg and 3.5 mg.
Important Safety InformationIntermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
Intermezzo, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking Intermezzo and may be fatal. Patients who develop angioedema or anaphylaxis after treatment with zolpidem should not be re-challenged with Intermezzo.
Abnormal thinking and behavior changes have been reported to occur in association with the use of sedative-hypnotics, including decreased inhibition, bizarre behavior, agitation, and depersonalization, as well as visual and auditory hallucinations. Complex behaviors such as \"sleep-driving\" and \"sleep-eating,\" with amnesia for the event, have been reported with sedative-hypnotics. The use of alcohol and other CNS depressants with zolpidem appears to increase the risk of such behaviors. Discontinuation of zolpidem should be strongly considered for patients who report a sleep-driving episode. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative-hypnotics. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation. Post-marketing reports of abuse, dependence, and withdrawal resulting from the use of oral zolpidem tartrate have been received. There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem.
Intermezzo should only be taken in bed. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Patients should not drive or undertake other dangerous activities after taking Intermezzo until they are fully awake. Patients should be cautioned about possible combined effects with CNS-depressant drugs. Intermezzo should not be taken with alcohol.
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1 Ohayon, M., Using difficulty resuming sleep to define nocturnal awakenings. Sleep Med. Mar 2010 11(3): 236241. 2 Intermezzo Prescribing Information. November 2011.
SOURCE: Transcept Pharmaceuticals, Inc.
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