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  #1  
Old 01-04-2012, 05:36
staples Gold member staples is offline
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Intermezzo® (zolpidem tartrate) sublingual tablets, CIV

[top]Intermezzo®

Intermezzo®, sublingual low-dose zolpidem tartrate, is a hypnotic that has been developed especially for people who have middle-of-the-night awakenings and who have at least 4 hours remaining to sleep. Most hypnotics are not approved for middle-of-the-night awakenings as they have doses or half-lives that could cause sedation around the time of awakening at the end of the sleep episode and therefore could impair alertness and be hazardous to activities such as driving.

[top]Indications and usage

Intermezzo is a GABAA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.

[top]Dosage and administration

  • Take only if 4 hours of bedtime remain before the planned time of waking.
  • Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole.
  • The effect of Intermezzo may be slowed if taken with or immediately after a meal.
  • Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only once per night if needed.
  • Lower doses of CNS depressants may be necessary when taken concomitantly with Intermezzo.
  • Co-administration with CNS depressants: Recommended dose is 1.75 mg for men and women.
  • Geriatric patients and patients with hepatic impairment: Recommended dose is 1.75 mg for men and women.

[top]Dosage forms and strengths

1.75 mg and 3.5 mg sublingual tablets.

[top]Contraindicatoins

Known hypersensitivity to zolpidem.

[top]Warnings and precautions

  • CNS depressant effect: Impairs alertness and motor coordination. Instruct patients on correct use.
  • Evaluate for co-morbid diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use.
  • Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not re-challenge if such reactions occur.
  • "Sleep-driving" and other complex behaviors while not fully awake. Risk increases with dose and use with other CNS depressants and alcohol. Immediately evaluate any new onset behavioral changes.
  • Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least number of tablets feasible to avoid intentional overdose.
  • Respiratory Depression: Consider the risk before prescribing in patients with compromised respiratory function.

[top]Adverse reactions

Most commonly observed adverse reaction (> 1% in adult patients) are headache, nausea, and fatigue.

To report SUSPECTED ADVERSE REACTIONS, contact Transcept, Inc. at 1-888-619-0188 or FDA at 1-800-FDA-1088 or http://www.fda.gove/medwatch.

[top]Drug interactions

  • CNS depressants, including alcohol: Possible adverse additive CNS depressant effects.
  • Imipramine: Decreased alertness observed.
  • Chlorpromazine: Impaired alertness and psychomotor performance observed.
  • Rifampin: Combination use may decrease effect.
  • Ketoconazole: Combination use may increase effects.

[top]Use in specific populations

  • Pregnancy: Based on animal data, zolpidem may cause fetal harm.
  • Pediatric use: Safety and effectiveness of Intermezzo not established. With bedtime dosing of zolpidem, hallucinations observed (incidence 7%).

Full Prescribing Information
Attached Files
File Type: pdf 022328lbl.pdf (205.7 KB, 4 views)
  #2  
Old 12-04-2012, 17:14
Emin Emin is offline
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Re: Intermezzo® (zolpidem tartrate) sublingual tablets, CIV

I saw this about a month ago, I'm considering asking my doctor about getting some. To me, it makes more sense to make a zaleplon sublingual formulation because of the short half-life.

This is a very good site for newly approved drugs: http://www.drugs.com/newdrugs.html
  #3  
Old 12-04-2012, 18:38
staples Gold member staples is offline
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Re: Intermezzo® (zolpidem tartrate) sublingual tablets, CIV

Quote:
Originally Posted by Emin View Post
I saw this about a month ago, I'm considering asking my doctor about getting some. To me, it makes more sense to make a zaleplon sublingual formulation because of the short half-life.
While Zaleplon isn't specifically approved for middle-of-the-night awakenings, it is noted throughout literature on the nonbenzodiazepines that zaleplon's short duration implicates its use for this purpose, and its maximum recommended daily dose of 20mg allows doctors to easily prescribe enough for the patient to use it in the middle of the night if necessary. In other words: short of achieving on-label use, zaleplon in its oral formulation is already considered and appropriate agent for middle-of-the-night awakenings (at least in the US).

I was particularly excited to find out that zaleplon could be used this way, but unfortunately I was disappointed with zaleplon's efficacy (or, lack thereof). That is why I was happy to come across this new formulation of zolpidem. However, if you have found zaleplon effective and would like to use it for middle-of-the-night awakenings, your doctor may be happy to prescribe it for such (or s/he may not be familiar with this usage, in which case, you should use your discretion regarding finding a more specialized doctor or bringing this use to your current doctor's attention). I've uploaded the following (and there should be other papers/reviews already in the archive which mention this usage, but I'm sure I can find more if there aren't): Zaleplon: A Review of its Use in the Treatment of Insomnia.

Quote:
Originally Posted by Zaleplon: A Review of its Use in the Treatment of Insomnia
The pharmacokinetic profile of zaleplon (short t˝β and lack of active metabolites) makes this drug particularly well suited for patients with sleep onset insomnia. Its short duration of action and its rapid absorption enables zaleplon to be used on an ‘as needed’ basis. Thus, the patient does not have to predict which nights insomnia is likely to occur and can control administration of the drug. In addition, because of its lack of next-day effects, zaleplon is useful for middle-of-the-night administration as long as patients then receive at least 4 hours sleep after taking the dose.
Thanks for the link!

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ambien, insomnia treatment, sublingual administration, zolpidem, zolpidem tartrate

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