Temazepam
Generic Name: temazepam
Brand Names:
Temazepam
DESCRIPTION Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1, 3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is: C 16 H 13 ClN 2 O 2 MW = 300.7 Temazepam, USP is a white or almost white crystalline powder, freely slightly soluble in methanol and methylene chloride. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.
Overview
DESCRIPTION Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1, 3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is: C 16 H 13 ClN 2 O 2 MW = 300.7 Temazepam, USP is a white or almost white crystalline powder, freely slightly soluble in methanol and methylene chloride. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.
Uses
INDICATIONS AND USAGE Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Dosage
DOSAGE AND ADMINISTRATION While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined. Discontinuation or Dosage Reduction of Temazepam Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.
Side Effects
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam capsules at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam Capsules % Incidence (n=1076) Placebo %Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System –...
Interactions
Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Warnings
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe temazepam capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/.
Storage
HOW SUPPLIED Temazepam Capsules, USP 15 mg Maroon cap / Opaque pink body, size 3, hard gelatin capsules imprinted with “A223” on body in black ink, filled with white to off white powder. NDC 51407-507-05 Bottle of 500 capsules 30 mg Maroon cap / Opaque blue body, size 3, hard gelatin capsules imprinted with “A225” on body in black ink, filled with white to off white powder.
Frequently Asked Questions
What is Temazepam used for?▼
INDICATIONS AND USAGE Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
What are the side effects of Temazepam?▼
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam capsules at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam Capsules % Incidence (n=1076) Placebo %Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System –...
Can I take Temazepam during pregnancy?▼
Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/.
What are the important warnings for Temazepam?▼
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe temazepam capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.