zaleplon 5 MG Oral Capsule

INDICATIONS AND USAGE Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ) . It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.

West-Ward Pharmaceuticals Corp.

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] febrile neutropenia` `[3] off label use` `[4] pneumonia` `[5] pyrexia` `[6] drug ineffective` `[7] nausea` `[8] diarrhoea` `[9] headache` `[10] death`

5 years ago

CAPSULE GREEN 54 656

5 years ago

54 656 CAPSULE GREEN

HOW SUPPLIED

ZALEPLON capsules, USP 5 mg capsule is supplied as a light green opaque capsule with “54 656” printed in black ink on cap and body, containing a white to an off-white powder. NDC 0054-0084-25: Bottle of 100 capsules 10 mg capsule is supplied as a green opaque capsule with “54 888” printed in black ink on cap and body, containing a white to an off-white powder. NDC 0054-0085-25: Bottle of 100 capsules STORAGE CONDITIONS Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000505/01 Revised February 2023

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zaleplon 5 MG Oral Capsule

FDA Reported Adverse Reactions [1] dyspnoea [2] febrile neutropenia [3] off label use [4] pneumonia [5] pyrexia [6] drug ineffective [7] nausea [8] diarrhoea [9] headache [10] death

CAPSULE GREEN 54 656

54 656 CAPSULE GREEN

More pills like CAPSULE 54 656

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] febrile neutropenia` `[3] off label use` `[4] pneumonia` `[5] pyrexia` `[6] drug ineffective` `[7] nausea` `[8] diarrhoea` `[9] headache` `[10] death`