Information about Intermezzo for your patients

Navigate through the sections below for important information about Intermezzo for your patients.

Where can I check the formulary coverage of Intermezzo?

View the formulary coverage of Intermezzo in your area with the Formulary Status Tool. Simply select the state, region, and insurance plan to see your patients’ Intermezzo formulary status.

Inclusion on formulary does not imply superior clinical efficacy or safety.

Are there any savings programs for my patients?

Trial and Savings Cards are no longer available online. However, existing savings cards (marked with an expiration date of March 31, 2014) will be honored up to June 30, 2014. If you are looking for ways for your patients to save on your Intermezzo prescription please visit our partner RelayHealth and learn more about the eVoucherRx™ program, which provides real-time electronic coupons to help reduce out-of-pocket expenses on Intermezzo.

How should patients take Intermezzo?

Read the Instructions for Use at the end of the Medication Guide for detailed instructions on how your patients should take Intermezzo.

Intermezzo is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Limitations of Use: Intermezzo should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking.

  • Intermezzo is to be taken exactly as prescribed. Patients take only one Intermezzo tablet per night if needed
  • Patients should not take Intermezzo if they drank alcohol that evening or before bed
  • The Intermezzo tablet pack should be removed from the pouch just prior to dosing
  • While in bed, Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing
  • The tablet should not be swallowed whole
  • For optimal effect, Intermezzo should not be administered with or immediately after a meal
  • If your patient's insomnia fails to improve after 7 to 10 days, it may indicate the presence of primary psychiatric and/or medical illness that should be evaluated

How should Intermezzo be stored?

  • Patients should store Intermezzo at room temperature, 68° to 77°F (20° to 25°C) and protect Intermezzo from moisture
  • The patient should be instructed not to remove the Intermezzo tablet from the unit-dose pouch until the patient is ready to consume it
  • Tell patients to keep Intermezzo out of reach of children

What is the most important information my patients should know about Intermezzo?

Patients must follow the Instructions for Use at the end of the Medication Guide when they take Intermezzo. If patients do not follow the Instructions for Use, they might be drowsy in the morning without knowing it.

  • Intermezzo is to be taken only once per night, if needed
  • Tell patients that Intermezzo should only be taken if they have at least 4 hours of bedtime left

Intermezzo may cause serious side effects in patients, including:

  • Getting up out of bed while not being fully awake and doing an activity that they do not know they are doing. Patients may not remember these events the next morning. Patients have a higher chance for doing these activities if they drank alcohol that day or take other medicines that make them sleepy with Intermezzo. Reported activities include:
    • driving a car (“sleep-driving”)
    • making and eating food
    • talking on the phone
    • having sex
    • sleepwalking
  • Tell patients to take Intermezzo exactly as prescribed
  • Patients should not take Intermezzo if they:
    • drank alcohol that day or before bed
    • took another medication for sleep
    • do not have at least 4 hours of bedtime remaining

Who should not take Intermezzo?

  • Patients with hypersensitivity to zolpidem or any other ingredients in Intermezzo. Refer to the end of the Medication Guide for a complete list of ingredients in Intermezzo
  • Patients who have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Edluar, or Zolpimist

Observed reactions with zolpidem include anaphylaxis and angioedema.

Intermezzo may not be right for some patients. Talk to your patients about all of their health conditions, including if they:

  • Have a history of depression, mental illness, or suicidal thoughts
  • Have a history of drug or alcohol abuse or addiction
  • Have a hepatic impairment
  • Have a respiratory condition
  • Are pregnant, planning to become pregnant, or breastfeeding
  • Are taking any other prescription or non-prescription medications

What are the possible side effects of Intermezzo?

Intermezzo may cause serious side effects in patients, including:

  • Complex behaviors such as “sleep-driving,” preparing and eating food, making phone calls, or having sex, with no memory of the event
  • Abnormal thinking and behavioral changes. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions
  • Memory loss
  • Anxiety
  • Severe anaphylactic and anaphylactoid reactions. Symptoms involve swelling of the tongue or throat, dyspnea, and nausea and vomiting. Patients who develop any of these symptoms should not be rechallenged with Intermezzo.

The most commonly reported adverse events of Intermezzo are:

  • Headache
  • Nausea
  • Fatigue
  • Monitor patients for tolerance, abuse, and dependence.

These are not all the side effects of Intermezzo. Please read the Full Prescribing Information.

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Important Safety Information

Intermezzo® (zolpidem tartrate) is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.

Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after taking Intermezzo, such that a potential negative effect on driving cannot be completely excluded.

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.

Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking zolpidem and may be fatal. Patients who develop angioedema or anaphylaxis should not be rechallenged.

Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as “sleep-driving” have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a “sleep-driving” episode.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.

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 a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.

The most commonly observed adverse reactions (>1%) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).

Please read the Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

Intended for healthcare professionals of the United States of America only. ©2014 Purdue Pharma L.P., Stamford, CT 06901-3431

Important Safety Informationclick to expand

Intermezzo® (zolpidem tartrate) is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.

Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after taking Intermezzo, such that a potential negative effect on driving cannot be completely excluded.

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.

Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking zolpidem and may be fatal. Patients who develop angioedema or anaphylaxis should not be rechallenged.

Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as “sleep-driving” have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a “sleep-driving” episode.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.

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 a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.

The most commonly observed adverse reactions (>1%) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).

Please read the Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

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