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AMBIEN CR (Zolpidem Tartrate Extended Release) Sleep Aid

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References

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References

  1. Consumer Health Sciences. The Insomnia/Sleep Difficulties Market—Key Results. National Health and Wellness Survey, 2008 [US]. Princeton, NJ; Consumer Health Sciences; June 2008.
  2. Krystal, AD, Erman M, Zammit GK, Soubrane C, Roth T; on behalf if the ZOLONG Study Group. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep.2008;31(1):79-90.
  3. Erman M, Guiraud A, Joish VN, Lerner D. Zolpidem extended-release 12.5 mg associated with improvements in work performance in a 6-month randomized, placebo-controlled trial. Sleep.2008;31(10):1371-1378.
  4. Ambien CR® (zolpidem tartrate extended release) Prescribing Information. Bridgewater, NJ: sanofi-aventis Inc; 2009.
  5. Ambien CR® Now available in the US for the Treatment of Insomnia [press release]. Paris, France: sanofi-aventis; October 7, 2005.
  6. Bogan RK. Treatment options for insomnia—pharmacodynamics of zolpidem extended-release to benefit next-day performance. Postgrad Med. 2008;120(3):161-171.
  7. Weinling E, McDougall S, Andre F, Bianchetti G, Dubruc C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol. 2006;20(4):397-403.
  8. Lieberman JA. Update on the safety considerations in the management of insomnia with hypnotics: incorporating modified-release formulations into primary care. Prim Care Companion J Clin Psychiatry. 2007;9(1):25-31.
  9. Ambien® (zolpidem tartrate) Prescribing Information. Bridgewater, NJ: sanofi-aventis Inc; 2009.
  10. Data on file, sanofi-aventis, PDY 4054.
  11. Stanley N, Hindmarch I, Legangneux E, Emegbo S. Zolpidem modified-release formulation has greater persistence of activity compared to standard zolpidem in a pharmacodynamics model assessing the return to sleep following nocturnal awakening. Poster presented at: 158th Annual Meeting of the American Psychiatric Association; May 21-26, 2005; Atlanta, Georgia.
  12. Emsellem HA. Insomnia and speaking to your healthcare provider about sleep problems. National Sleep Foundation Web site. http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.4407737/k.9301/Faculty_Lounge.htm Accessed May 13, 2009.
  13. Wang JS, DeVane CL. Pharmacokinetics and drug interactions of the sedative hypnotics. Psychophramacol Bull. 2003;37(1):10-29.
  14. Taylor DJ, Lichstein KL, Durrence HH, Reidel BW, Bush AJ. Epidemiology of insomnia, depression, and anxiety. Sleep. 2005;28(11):1457-1464.
  15. Ohayon MM, Caulet M, Lemoine P. Comorbidity of mental and insomnia disorders in the general population. Compr Psychiatry. 1998;39(4):185-197.
  16. Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003 Jan-Feb;37(1):9-15.
  17. Data on file, sanofi-aventis, CSR 0166.
  18. Data on file, sanofi-aventis, CSR 0167.
  19. Neylan TC. Treatment of sleep disturbances in depressed patients. J Clin Psychiatry. 1995;56(Suppl.)2:56-61.
  20. National Sleep Foundation Sleep Report Card. National Sleep Foundation Web site. http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.4401667/k.B8D1/Sleep_Report_Card.htm. Accessed May 13, 2009.
  21. Breslau N, Roth T, Rosenthal L, Andreski P. Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults. Biol Psychiatry. 1996;39(6):411-418.
  22. Thase ME. Antidepressant treatment of the depressed patient with insomnia. J Clin Psychiatry. 1999;60(Suppl.17):28-31.
  23. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005;56(3):332-343.
  24. Sleep aids: can antihistamines help me sleep? Mayo Clinic Web site.
    http://www.mayoclinic.com/health/sleep-aids/AN01820, Accessed May 13, 2009.
  25. Kupfer DJ and Reynolds CF. Management of Insomnia. N Engl J Med. 1997;336(5):341-346.
  26. Kay GG. The effects of antihistamines on cognition and performance. J Allergy Clin Immunol. 2000;105(6 Pt 2):S622-7.
  27. OTC sleep aids and supplements: What’s best and safe? Mayo Clinic Web site.
    http://www.mayoclinic.com/health/sleep-aids/SL00016, Accessed May 13, 2009.
  28. Olubodun JO, et al. Pharmacokinetic properties of zolpidem in elderly and young adults: possible modulation by testosterone in men. Br J Clin Pharmacol. 2003;56(3):297-304.
pagedivide

* Maximum benefit is $240 off, up to $20 off each prescription (up to 12 prescriptions), depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

IMPORTANT SAFETY INFORMATION

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 6.25 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep. Patients should not take AMBIEN CR unless they are prepared to get a full night’s sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN CR should not be taken with alcohol as it may increase these abnormal behaviors. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The most commonly observed adverse effects in controlled clinical trials were headache, somnolence, and dizziness. Because individuals with a history of addiction or substance abuse are at increased risk of habituation and dependence, they should be under careful surveillance when receiving AMBIEN CR or any other hypnotic. AMBIEN CR is a Schedule IV controlled substance.

Please refer to the full prescribing information.