{"id":"zolpidem","brandName":"Ambien","genericName":"zolpidem","companyId":"sanofi","companyName":"Sanofi","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Ambien, also known as zolpidem, is a medication primarily used for the short-term treatment of sleeping problems, specifically insomnia. It works by acting as a positive allosteric modulator of the GABA A receptor alpha-1/beta-1/gamma-2, helping to decrease the time to sleep onset and improve sleep duration.","enrichmentLevel":3,"visitCount":2,"mechanism":{"target":"α1 subunit containing GABA A receptors","modality":"Small molecule","explanation":"Zolpidem works by binding to specific sites on GABA A receptors that contain the α1 subunit. This binding increases the frequency at which chloride channels open, leading to a reduction in neuronal activity and promoting sleep.","oneSentence":"Zolpidem binds to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing chloride channel opening and inhibiting neuronal excitation.","technicalDetail":"Zolpidem is a GABA A receptor positive modulator that binds to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening, which results in the inhibition of neuronal excitation."},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: COMPLEX SLEEP BEHAVIOUR Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Tablets. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Tablets . Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )"],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"8549 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"8379 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"8148 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"6370 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"6250 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"6221 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"5864 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"5525 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"5423 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"5194 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Headache","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Drowsiness","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Drugged feelings","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Daytime drowsiness","drugRate":"1.1%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Dizziness/vertigo","drugRate":"0.8%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"0.6%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Amnesia","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Falls","drugRate":"0.4%","severity":"common","organSystem":""},{"effect":"Impaired 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suicide","drugRate":"0.5%","severity":"serious"}]},"trials":["NCT01485393","NCT02671760","NCT03885141","NCT00976105","NCT00833521","NCT04118387","NCT01987739","NCT05106153","NCT02456532","NCT03056053","NCT01685073","NCT00492232","NCT02839200","NCT01243060","NCT00770510","NCT05746143","NCT01551485","NCT00086281","NCT00999219","NCT00042146","NCT02783729","NCT00283946","NCT02374567","NCT00956319","NCT00784875","NCT01181232","NCT07420816","NCT00466193","NCT00814502","NCT00568789","NCT02648776","NCT00227942","NCT00777829","NCT00283790","NCT01071889","NCT03375203","NCT01024192","NCT03269760","NCT06640023","NCT02484963","NCT01920334","NCT01689909","NCT00286936","NCT03331042","NCT01006525","NCT02607696","NCT00440323","NCT06512155","NCT00939367","NCT02578472"],"indications":{"approved":[{"name":"Initial insomnia","diseaseId":"initial-insomnia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United 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