HealthDay News — Hypnotic sleep aid use was associated with a three- to five-fold higher mortality risk compared to nonuse, even among patients taking relatively few pills a year, study data indicate.

Patients prescribed 0.4 to 18 doses per year had a hazard ratio of 3.60 compared with patients who did not have a prescription for hypnotics, Daniel F. Kripke, MD, from the Scripps Clinic Viterbi Family Sleep Center in La Jolla, Calif., and colleagues reported in BMJ Open.

Dosing increases correlated with higher mortality risks, with the hazard ratio climbing to 4.43 among those prescribed 18 to 132 doses a year, and 5.32 for those prescribed more than 132 doses per year (P<0.001 for all comparisons versus nonusers).

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Between 320,000 to 507,000 excess deaths associated with hypnotics were estimated to have occurred in the United States in 2010, according to the researchers.

“From this nonrandomized study, we cannot be certain what portion of the mortality associated with hypnotics may have been attributable to these drugs, but the consistency of our estimates across a spectrum of health and disease suggests that the mortality effect of hypnotics was substantial,” the researchers wrote.

They noted that patients prescribed the highest doses of hypnotics had an increased risk for cancer (1.35).

The longitudinal cohort study examined data from 10,529 patients included in a large U.S. health system database that had at least one prescription for a hypnotic drug between Jan. 1, 2002 to Sept. 30, 2006, who were matched with 23,674 patients who did not have a prescription for a hypnotic during the study period.

Hypnotic users were mostly women (63.9%) with a mean age of 54 years, and the most frequently used sleeping pills were zolpidem (4,338) and temazepam (2,076). During the 2.5 year follow up period, the mean morbidity score was 1.53 among hypnotic users. Overall, 6.1% of sleeping pill users died compared with 1.2% of nonusers.

“Against meager benefits, it is prudent to weigh the evidence of mortality risks from the current study and 24 previous reports, in order to reconsider whether even short-term use of hypnotics, as given qualified approval in National Institute for Clinical Excellence guidance, is sufficiently safe,” the researchers concluded.

Kripke DF. BMJ Open. 2012; 2: e000850.