Outpatient studyIntermezzo reduced subjective (patient-estimated) time to fall back asleep after middle-of-the-night awakening compared to placebo

Mean time to fall back asleep after middle-of-the-night awakening was significantly shorter for Intermezzo 3.5 mg (38 minutes) compared to placebo (56 minutes)1,2

Intermezzo 3.5 mg decreased the time to fall back asleep after a middle-of-the-night awakening by approximately
30 minutes from baseline through 4 weeks1,2

Mean time to fall back asleep and reductions from baseline averaged across 4-week treatment period1,2

*P<0.0001 vs placebo.

  • Patients took Intermezzo 3.5 mg during the night on 62% of study nights1

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.

References: 1. Intermezzo Prescribing Information. Purdue Pharma L.P. 2. Roth T, Krystal A, Steinberg FJ, Singh NN, Moline M. Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study. Sleep. 2013;36(2):189-196.

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

Study design1,2

  • A randomized, double-blind, placebo-controlled, parallel- group, 4-week outpatient study in adult patients aged 18 to 64 years (N=295; 201 women, 94 men) with a history of insomnia characterized by difficulty returning to sleep after middle-of-the-night awakenings
  • Patients met diagnosis for primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR™) and had at least 3 prolonged middle-of-the-night awakenings per week that were at least 30 minutes in duration
  • Patients were randomized to Intermezzo 3.5 mg or placebo taken on a once-nightly, as-needed basis. Patients qualified to take study medication by calling an interactive voice response system (IVRS) after a middle-of-the-night awakening to confirm that they had been awake for at least 10 minutes and still had at least 4 hours remaining in bed
  • Each morning, patients called the IVRS and responded to questions about their sleep

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.

You are now leaving IntermezzoRX.com. If you wish to leave, please click Continue.