Temazepam shares the actions of other benzodiazepines and is used as a hypnotic agent in the short-term treatment of insomnia generally for periods not exceeding 7-10 days in duration. The failure of insomnia to remit after 7-10 days of temazepam therapy may indicate the presence of an underlying psychiatric and/or medical condition. Prolonged use of hypnotics is usually not indicated and should be undertaken only upon further evaluation of the patient. The possibility that insomnia may be a symptom of an underlying condition for which there may be a more specific treatment should be considered.
Administration 
Temazepam is administered orally at bedtime.
Dosage
Dosage of temazepam must be individualized, and the smallest effective dosage should be used (especially in geriatric or debilitated patients or in those with liver disease or low serum albumin). Prolonged administration of temazepam should be avoided.
The usual adult dose of temazepam is 15 mg; however, 7.5 mg may be adequate in some patients, while others may require 22.5 or 30 mg. For transient insomnia, 7.5 mg may be adequate to improve sleep latency. In geriatric or debilitated patients, an initial dose of 7.5 mg should be used until individual response is determined. In patients who have received prolonged (e.g., for several months) temazepam therapy at dosages exceeding 15 mg daily, abrupt discontinuance of the drug should be avoided since manifestations of withdrawal can be precipitated; if the drug is to be discontinued in such patients, it is recommended that dosage be gradually tapered.
A boxed warning has been included in the prescribing information for all benzodiazepines describing the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with all drugs in this class.900 Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs.900 Frequent follow-up with patients receiving benzodiazepines is important.900 Reassess patients regularly to manage their medical conditions and any withdrawal symptoms.900 Clinicians should assess a patient's risk of abuse, misuse, and addiction. 900 Standardized screening tools are available ([Web]).900 To reduce the risk of acute withdrawal reactions, use a gradual dose taper when reducing the dosage or discontinuing benzodiazepines.900 Take precautions when benzodiazepines are used in combination with opioid medications.900
Temazepam shares the toxic potentials of the benzodiazepines, and the usual precautions of benzodiazepine administration should be observed. (See Cautions in the Benzodiazepines General Statement 28:24.08.)
Pediatric Precautions
Safety and efficacy of temazepam in children younger than 18 years of age have not been established.
Chemistry and Stability
Chemistry
Temazepam is a benzodiazepine. Temazepam occurs as a white, crystalline powder. The drug is very slightly soluble in water and sparingly soluble in alcohol.
Stability
Temazepam capsules should be stored in tight containers at 20-25°C.
Additional Information
For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, chronic toxicity, acute toxicity, drug interactions, laboratory test interferences, and dosage and administration of temazepam, see the Benzodiazepines General Statement 28:24.08.
AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions September 27, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
320. Rall TW. Hypnotics and sedatives; ethanol: benzodiazepines and management of insomnia. In: Gilman AG, Rall TW, Nies AS et al. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press; 1990:346-58,369-70.
358. Bloom FE. Neurohumoral transmission and the central nervous system: amino acids. In: Gilman AG, Rall TW, Nies AS et al, eds. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press; 1990:256-8.
359. Haefely W. The GABA-benzodiazepine interaction fifteen years later. Neurochem Res . 1990; 15:169-74. [PubMed 2159122]
360. De Feudis FV. Overview—GABAa receptors. Ann NY Acad Sci . 1990; 585:231-40. [PubMed 2162643]
361. Mohler H, Malherbe P, Draguhn A et al. GABAa-receptors: structural requirements and sites of gene expression in mammalian brain. Neurochem Res . 1990; 15:199-207. [PubMed 2159125]
362. Farrant M, Gibbs TT, Farb DH. Molecular and cellular mechanisms of GABA/benzodiazepine-receptor regulation: electrophysiological and biochemical studies. Neurochem Res . 1990; 15:175-91. [PubMed 2159123]
363. Sieghart W. Benzodiazepine receptor subtypes and their possible clinical significance. Psychopharmacol Ser . 1989; 7:131-7. [PubMed 2574448]
364. Knapp RJ, Malatynska E, Yamamura HI. From binding studies to the molecular biology of GABA receptors. Neurochem Res . 1990; 15:105-12. [PubMed 2159117]
365. Williams M. Anxioselective anxiolytics. J Med Chem . 1983; 26:619-28. [PubMed 6132997]
366. Rogawski MA, Porter RJ. Antiepileptic drugs: pharmacological mechanisms and clinical efficacy with consideration of promising developmental stage compounds. Pharmacol Rev . 1990; 42:223-86. [PubMed 2217531]
367. Haefely WE. Pharmacology of the benzodiazepine receptor. Eur Arch Psychiatry Neurol Sci . 1989; 238:294-301. [PubMed 2569974]
368. Haefely WE. Benzodiazepines. Int Anesthesiol Clin . 1988; 26:262-72. [PubMed 2461909]
369. Schoch P, Richards JG, Haring P et al. Co-localization of GABA receptors and benzodiazepine receptors in the brain shown by monoclonal antibodies. Nature . 1985; 314:168-71. [PubMed 2983231]
370. Haefely W. Endogenous ligands of the benzodiazepine receptor. Pharmacopsychiatry . 1988; 21:43-6. [PubMed 2834760]
629. Food and Drug Administration. Sedative-hypnotic drug products. [March 14, 2007] MedWatch drug labeling changes. Rockville, MD; April 2007. From FDA website. [Web]
700. US Food and Drug Administration. Drug safety communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. Silver Spring, MD; 2016 Aug 31. From FDA website. [Web]
701. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA . 2013; 309:657-9. [PubMed 23423407]
703. Hughes A. Letter to manufacturers of benzodiazepines: safety labeling change notification. Silver Spring, MD: US Food and Drug Administration. Accessed 2017 Mar 20. [Web]
704. Seymour S. Letter to manufacturers of opioid antitussives: safety labeling change notification. Silver Spring, MD: US Food and Drug Administration. Accessed 2017 Mar 20. [Web]
705. Park TW, Saitz R, Ganoczy D et al. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ . 2015; 350:h2698. [PubMedCentral][PubMed 26063215]
706. Jones CM, McAninch JK. Emergency Department Visits and Overdose Deaths From Combined Use of Opioids and Benzodiazepines. Am J Prev Med . 2015; 49:493-501. [PubMed 26143953]
707. Dasgupta N, Funk MJ, Proescholdbell S et al. Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality. Pain Med . 2016; 17:85-98. [PubMed 26333030]
708. Nuckols TK, Anderson L, Popescu I et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med . 2014; 160:38-47. [PubMed 24217469]
709. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep . 2016; 65:1-49. [PubMed 26987082]
710. Manchikanti L, Abdi S, Atluri S et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician . 2012; 15(3 Suppl):S67-116.
711. New York City Department of Health and Mental Hygiene. New York City emergency department discharge opioid prescribing guidelines. From NYC Health website. 2013 Jan. [Web]
712. Washington State Agency Medical Directors' Group (AMDG). Interagency guideline on prescribing opioids for pain, 3rd ed. From Washington State AMDG website. 2015 Jun. [Web]
900. US Food and Drug Administration. Drug safety communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class Includes potential for abuse, addiction, and other serious risks. Silver Spring, MD; 2020 Sep 23. From FDA website. [Web]