"The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
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The following serious adverse reactions are discussed in greater detail in other sections of the label:
- CNS-depressant effects and next-day impairment [see WARNINGS AND PRECAUTIONS]
- Benzodiazepine withdrawal syndrome[see WARNINGS AND PRECAUTIONS]
- Abnormal thinking and behavior changes, and complex behaviors[see WARNINGS AND PRECAUTIONS]
- Worsening of depression[see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of Doral. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.
|DORAL 15 mg||PLACEBO|
|NUMBER OF PATIENTS||267||268|
|% OF PATIENTS REPORTING|
|Central Nervous System|
|Autonomic Nervous System|
|Dry Mouth||2||< 1|
A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of quazepam 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be well tolerated. Caution must be used in interpreting this data due to the small size of the study.
Read the Doral (quazepam tablets) Side Effects Center for a complete guide to possible side effects
Benzodiazepines, including DORAL, produce additive CNS depressant effects when coadministered with ethanol or other CNS depressants (e.g. psychotropic medications, anticonvulsants, antihistamines). Downward dose adjustment of Doral and/or concomitant CNS depressants may be necessary because of additive effects.
Drug Abuse And Dependence
Quazepam is classified as a Schedule IV controlled substance by federal regulation.
Abuse and Dependence
Addiction-prone individuals (e.g. history of drug addiction or alcoholism) should be under careful surveillance when receiving Doral because of increased risk of abuse and dependence. Benzodiazepine withdrawal symptoms can occur following discontinuation of Doral [see WARNINGS AND PRECAUTIONS].
Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.
Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
Read the Doral Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/28/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Doral Information
Doral - User Reviews
Doral User Reviews
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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