Insomnia Relief Insomnia-Anxiety Omega Receptors Stay Asleep Sleep Efficiency Sleep Architecture Unique Benzodiazepine Metabolism Flexible Dosing Patient Assistance

Preserve sleep architecture

  • In a placebo-controlled study in 8 elderly patients with chronic insomnia, short-term use of Restoril™ 7.5 mg preserved sleep architecture (the percent of time spent in each of the sleep stages); REM sleep was not significantly different throughout the night.22
  • REM sleep essentially unchanged at all dosages.
 
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Important safety information: Restoril™ is indicated for the short-term treatment of insomnia (generally 7 to 10 days). 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. Restoril™ is contraindicated in women who are pregnant or may become pregnant because of the potential risk to the fetus. The most common side effects of Restoril™ are drowsiness, dizziness, lightheadedness, and difficulty with coordination. Severe allergic reactions have been reported in patients taking sedative-hypnotics, including Restoril™. Complex behaviors such as “sleep driving” have also been reported. Although behaviors such as “sleep driving” may occur with Restoril™ alone at therapeutic doses, the use of alcohol or other CNS depressants with Restoril™ appears to increase the risk of these unusual behaviors, as does the use of Restoril™ doses exceeding the maximum recommended dose. Use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft.

Healthcare Provider Letter

For more information about Restoril™ (temazepam) capsules, please read the complete prescribing information.

References: 1. Lader MH. Insomnia and short-acting benzodiazepine hypnotics. J Clin Psychiatry. 1983;44:47-53. 2. Erman MK, Loewy D, Scharf MB. Comparison of temazepam 7.5 mg with temazepam 15 mg for the treatment of transient insomnia. Curr Med Res Opin. 2004;20:441-449. 3. Elie R, Rüther E, Farr I, et al. Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. J Clin Psychiatry. 1999;60:536-544. 4. Morgan PJ, Chapados R, Chung FF, Gauthier M, Knox JWD, Le Lorier J. Evaluation of zolpidem, triazolam, and placebo as hypnotic drugs the night before surgery. J Clin Anesth. 1997;9:97-102. 5. Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003;26:793-799. 6. Roehrs T, Vogel G, Sterling W, Roth T. Dose effects of temazepam in transient insomnia. Arzneimittelforschung. 1990;40:859-862. 7. Restoril™ [package insert]. St Louis, Mo: Mallinckrodt Inc; 2002. 8. Charney DS, Mihic SJ, Harris RA. Hypnotics and sedatives. In: Hardman JG, Limbird LE, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001:399-427. 9. Xanax® [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn Co; 2001. 10. Valium® [package insert]. Manati, Puerto Rico: Roche Products; 2000. 11. Klonopin® [package insert]. Nutley, NJ: Roche Laboratories; 2001. 12. Cupp MJ, Tracy TS. Cytochrome P450: new nomenclature and clinical implications. Am Fam Physician. 1998;57:107-116. 13. National Sleep Foundation. When you can’t sleep: ABCs of ZZZs. Available at: http://www.sleepfoundation.org/publications/ZZZs.cfm. Accessed on October 28, 2004. 14. Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders: an opportunity for prevention? JAMA. 1989;262:1479-1484. 15. Breslau N, Roth T, Rosenthal L, Andreski P. Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults. Biol Psychiatry. 1996;39:411-418. 16. McKernan RM, Rosahl TW, Reynolds DS, et al. Sedative but not anxiolytic properties of benzodiazepines are mediated by the GABAA receptor a1 subtype. Nat Neurosci. 2000;3:587-592. 17. Stahl SM. Selective actions on sleep or anxiety by exploiting GABA-A/benzodiazepine receptor subtypes. J Clin Psychiatry. 2002;63:179-180. 18. Fry J, Scharf M, Mangano R, Fujimori M, and the Zaleplon Clinical Study Group. Int Clin Psychopharmacol. 2000;15:141-152. 19. Ambien® [package insert]. New York, NY: Sanofi-Synthelabo Inc; 2002. 20. Sonata® [package insert]. Bristol, Tenn: Monarch Pharmaceuticals; 2002. 21. Erman MK, Loewy D, Scharf MB. Effects of temazepam 7.5 mg and temazepam 15 mg on sleep maintenance and sleep architecture in a model of transient insomnia. Curr Med Res Opin. 2005;21:223-229. 22. Vgontzas AN, Kales A, Bixler EO, Myers DC. Temazepam 7.5 mg: effects on sleep in elderly insomniacs. Eur J Clin Pharmacol. 1994;46:209-213. 23. Moroz G. High-potency benzodiazepines: recent clinical results. J Clin Psychiatry. 2004;65(suppl 5):13-18. 24. Liebowitz MR, Coplan JD, Martinez J, et al. Effects of intravenous diazepam pretreatment on lactate-induced panic. Psychiatry Res. 1995;58:127-138. 25. Lewis KP, Stanley GD. Pharmacology. Int Anesthesiol Clin. 1999;37:73-86. 26. Lunesta™ [package insert]. Marlborough, Mass: Sepracor Inc; 2004. 27. Lipitor® [package insert]. New York, NY: Pfizer Parke-Davis; 2004. 28. Zoloft® [package insert]. New York, NY: Pfizer Inc; 2003. 29. Advair Diskus® [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2004. 30. Singulair® [package insert]. West Point, Pa: Merck & Co, Inc; 2004. 31. Viagra® [package insert]. New York, NY: Pfizer Inc; 2003. 32. Coumadin® [package insert]. Princeton, NJ: Bristol-Myers Squibb Co; 2002. 33. McNamara JO. Drugs effective in the therapy of the epilepsies. In: Hardman JG, Limbird LE, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001:521-547. 34. Nizoral® [package insert]. Titusville, NJ: Janssen Pharmaceutica; 1998. 35. Uniphyl® [package insert]. Stamford, Conn: Purdue Pharmaceutical Products LP; 2004.