UC San Diego

The undersigned, Daniel F. Kripke, M.D., submits this Citizen Petition under the Federal Food, Drug & Cosmetic Act, 21 C.F.R. §§ 10.30, to request that the Commissioner of Food and Drugs take the following administrative actions with respect to the so-called hypnotic drugs listed herein. For at least the following drugs: zolpidem, temazepam, szopiclone, zaleplon, triazolam, flurazepam, and quazepam, in all brands and forms prescribed to treat insomnia or patient reported sleep disorders, and any barbiturates including pentobarbital, amobarbital, and secobarbital still prescribed, either on- or off-label, to induce sleep, Petitioner requests the following actions.