temazepam
Generic: TEMAZEPAM
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
904b8986-24da-48eb-bb0a-33d41b4eb005
Indications & Usage
INDICATIONS AND USAGE Temazepam Capsules, USP 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, USP 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.
For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules, USP 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.
Warnings
WARNINGS Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
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.
Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior.
Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class.
Because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), it is important to use the lowest possible effective dose.
Elderly patients are especially at risk.
Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol.
Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons.
Although behaviors such as sleep-driving may occur with temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a "sleep-driving" episode.
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with sleep-driving, patients usually do not remember these events.
Amnesia and other neuro-psychiatric symptoms may occur unpredictably.
In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines ( see DRUG ABUSE AND DEPENDENCE ).
Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam.
Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.
Some patients have required medical therapy in the emergency department.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Patients who develop angioedema after treatment with temazepam should not be rechallenged with the drug.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
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.
Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior.
Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class.
Because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), it is important to use the lowest possible effective dose.
Elderly patients are especially at risk.
Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol.
Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons.
Although behaviors such as sleep-driving may occur with temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a "sleep-driving" episode.
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with sleep-driving, patients usually do not remember these events.
Amnesia and other neuro-psychiatric symptoms may occur unpredictably.
In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines ( see DRUG ABUSE AND DEPENDENCE ).
Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam.
Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.
Some patients have required medical therapy in the emergency department.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Patients who develop angioedema after treatment with temazepam should not be rechallenged with the drug.
Adverse Reactions
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam 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 % 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 2.0 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 - anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular - dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses - hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
Side effects were usually mild and transient.
Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam % 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 2.0 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 - anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular - dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses - hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).